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Completed

NCT Number: NCT03630705

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico

Primary Objective:

1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico. 2. To describe the vaccine seroprotection (antibody titer >=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.

Secondary Objective:

1. To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF). 2. To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone. 3. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF. 4. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

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Key information

Conditions

Healthy Volunteers (Meningococcal Infection) Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number :4840001, Acapulco de Juárez, Guerrero, Mexico

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About this study

Study duration per participant was approximately 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:

  • Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.*
  • Born after a full-term pregnancy, with an estimated gestation age >= 37 weeks and a birth weight >= 2.5 kilograms.
  • Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
  • Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
  • In good health as determined by medical history and physical assessment.
  • For the Russian Federation: The participant's parents were able to verbally report or provide written documentation that the participant's mother was hepatitis B antigen negative during pregnancy with the participant.
  • * "2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days).
  • † In the Russian Federation, as per local regulations, only the participant's parent(s) were entitled to sign an informed consent form. A child under the responsibility of a guardian would not be included in the study.

Exclusion criteria

An individual fulfilling any of the following criteria was to be excluded from trial enrollment:

  • Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., meningitis polysaccharide or meningitis Conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella.
  • For Mexico: More than 1 previous dose of hepatitis B vaccine.
  • Receipt of immune globulins, blood or blood-derived products since birth.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
  • Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
  • Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Individuals with active tuberculosis.
  • History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / disease.
  • At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
  • History of intussusception.
  • History of any neurologic disorders, including seizures (febrile and non-febrile) and progressive neurologic disorders.
  • History of Guillain-Barré syndrome.
  • Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
  • Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
  • Receipt of oral or injectable antibiotic therapy within 72 hours of the first blood draw.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
  • For the Russian Federation, febrile illness was defined as temperature >= 37°C. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Treatment and study plan

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine

Biological

Pharmaceutical form: Liquid solution Route of administration : Intramuscular

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Biological

Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular

Other names: Menveo®

Measles, Mumps, and Rubella Virus Vaccine Live

Biological

Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous

Other names: M-M-R®II

Pneumococcal 13-valent Conjugate Vaccine

Biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Other names: Prevnar 13®

Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine

Biological

Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular

Other names: Pentaxim®

Hepatitis B vaccine

Biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Other names: ENGERIX-B®

Rotavirus Vaccine, Live, Pentavalent

Biological

Pharmaceutical form: Oral solution Route of administration: Oral

Other names: RotaTeq®

Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine

Biological

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Other names: Hexacima®

Primary outcomes

  1. Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.

  2. Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3

    Time frame: 30 days after the last vaccination at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.

Secondary outcomes

  1. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)

    The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titers less than (<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  2. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the last vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination hSBA titers <1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  3. Geometric Mean Concentration of Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) Antibodies Before Vaccination With Hexacima® Vaccine Administered Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination with Hexacima® vaccine) of the infant series (i.e., at the age of 2 months)

    Geometric mean concentration (GMCs) for PT and FHA were measured by electrochemiluminescent (ECL) assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  4. Geometric Mean Concentrations of Anti-rotavirus Serum Immunoglobulin A (IgA) Antibodies Before and After RotaTeq® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months) and 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    GMCs of Anti-rotavirus serum IgA antibodies were assessed using enzyme-linked immunosorbent assay (ELISA). Concentrations were measured in terms of units/milliliter (U/mL). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  5. Geometric Mean Concentration of Anti-pneumococcal Antibodies After Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    GMCs of anti-pneumococcal antibodies was assessed by electrochemiluminscent (ECL) assay. GMCs of Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were reported. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  6. Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) After Prevnar 13® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Prevnar 13® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Percentage of participants with anti-pneumococcal antibody concentrations >=0.35 micrograms per milliliter (mcg/mL) and >=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  7. Percentage of Participants With >=3-fold and >=4-fold Rise in Anti-rotavirus Serum IgA Antibody Concentrations After RotaTeq® Vaccine Administered Alone or Along With MenACYW Conjugate or Menveo® Vaccine: Groups 1 & 2 (up to the Infant Age of 6 Months)

    Time frame: From Day 0 (before the first vaccination with RotaTeq® vaccine at the age of 2 months), 30 days after the vaccination with RotaTeq® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Anti-rotavirus IgA antibodies in human serum was measured by ELISA. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after 6-months vaccination) to pre-dose titer at age of 2 months (i.e., Day 0). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  8. Geometric Mean Titers (GMTs) of MMR Antibodies Following Vaccination With M-M-R®II Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMTs against anti-measles and anti-rubella antibodies were measured by Bulk Measles immunoglobulin G (IgG) Enzyme Immunoassay (EIA) and anti-mumps antibodies were assessed by ELISA. Titers were expressed in terms of 1/dilution.

  9. Geometric Mean Concentration of Anti-pneumococcal Antibodies Following Vaccination With Prevnar 13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with Prevnar13® vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMCs against Streptococcus pneumoniae polysaccharide (PS) serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution).

  10. Percentage of Participants With Anti-pneumococcal Antibody Concentrations (>=0.35 mcg/mL and >=1.0 mcg/mL) Following Vaccination With Prevnar13® Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with Prevnar 13® vaccine at the age of 12 months (i.e., at the age of 13 months)

    Percentage of participants with anti-pneumococcal antibody concentrations >=0.35 mcg/mL and >=1.0 mcg/mL for Prevnar 13 serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F was reported in this outcome measure.

  11. Percentage of Participants With Anti-MMR Antibodies (Ab) Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with M-M-R®II vaccine at the age of 12 months (i.e., at the age of 13 months)

    Percentage of participants with anti-measles Ab concentrations >=255 milli-international unit per milliliter (mIU/mL), anti-mumps Ab concentrations: >=10 Ab units/mL, and anti-rubella Ab concentrations >=10 international unit per milliliter (IU/mL) was reported in this outcome measure.

  12. Percentage of Participants With Antibodies Concentrations Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)

    Percentage of participants with anti-diphtheria Ab concentrations: >= 0.1 and 1 IU/mL, and anti-tetanus Ab concentrations: >= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers >= 8 (1/dilution), anti-hepatitis B surface (HBs) antigen Ab concentrations: >= 10 and >= 100 mIU/mL and anti-polyribosyl-ribitol phosphate (anti-PRP) Ab concentrations: >= 0.15 and 1.0 microgram per milliliter (mcg/mL) was reported in this outcome measure.

  13. Percentage of Participants With Vaccine Response for Pertussis (PT) and FHA Antibodies Following Vaccination With Hexacima® (DTaP-IPV-HB-Hib) Vaccine Administered Alone or Along With the MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with Hexacima® vaccine at the age of 12 months (i.e., at the age of 13 months)

    Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was >=4*lower limit of quantification (LLOQ), then the post-vaccination concentration was >=pre-vaccination concentration and if the pre-vaccination concentration was <4*LLOQ, then the post-booster vaccination concentration was >= 4*LLOQ. The LLOQ was equal to 2.00 Endotoxin units per milliliter (EU/mL).

  14. Geometric Mean Concentration of PT and FHA Antibodies Before Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before first vaccination with Pentaxim® vaccine) of the infant series (i.e., at the age of 2 months)

    GMCs for PT and FHA were measured by ECL assay. Concentration was expressed in terms of titers (1/dilution). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  15. Percentage of Participants With Antibodies Concentrations Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)

    Percentage of participants with anti-diphtheria Ab concentrations: >= 0.1 and 1 IU/mL, anti-tetanus Ab concentrations: >= 0.1 and 1 IU/mL, anti-poliovirus types 1, 2, and 3 Ab titers >= 8 (1/dilution), and anti-PRP Ab concentrations: >= 0.15 and 1.0 mcg/mL were reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  16. Percentage of Participants With Vaccine Response for PT and FHA Antibodies Following Vaccination With Pentaxim® (DTaP-Hib-IPV) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Pentaxim® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Pertussis and FHA vaccine response was defined as: if the pre-vaccination concentration was >=4*LLOQ, then the post-vaccination concentration was >= pre-vaccination concentration and if the pre-vaccination concentration was <4*LLOQ, then the post-booster vaccination concentration was >= 4*LLOQ. The LLOQ was equal to 2.00 EU/mL. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  17. Percentage of Participants With Anti-Hepatitis (HBs) Concentrations Following Vaccination With ENGERIX-B® (Hepatitis B) Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with ENGERIX-B® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Percentage of participants with anti-hepatitis B surface (HBs) antigen Ab concentrations: >=10 and >=100 mIU/mL was presented in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  18. Geometric Mean Concentrations of MMR Antibodies Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Conjugate Vaccine: Groups 3 and 4

    Time frame: 30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMCs against anti-measles and anti-rubella antibodies were measured by Bulk Measles IgG EIA, and anti-mumps antibodies were assessed by ELISA. Concentrations were expressed in terms of titers (1/dilution).

  19. Percentage of Participants With Anti-MMR Concentrations Following Vaccination With MMR Vaccine Administered Alone or Along With the MenACYW Vaccine or Routine Pediatric Vaccines: Groups 3 and 4

    Time frame: 30 days after the vaccination with MMR vaccine at the age of 12 months (i.e., at the age of 13 months)

    Percentage of participants with anti-measles Ab concentrations >=255 mIU/mL, anti-mumps Ab concentrations: >=10 Ab units/mL, and anti-rubella Ab concentrations >=10 IU/mL was reported in this outcome measure.

  20. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Before Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination with MenACYW Conjugate or Menveo® Vaccine) of the infant series (i.e., at the age of 2 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  21. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  22. Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccines: Groups 1 and 3 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months of the infant series (i.e., at the age of Month 7)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  23. Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3 (up to the Infant Age of 6 Months)

    Time frame: From Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with MenACYW Conjugate vaccine at the age of 6 months of infant series (i.e., at the age of 7 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the 6-months vaccination) to pre-dose titer at 2 months of age (i.e., Day 0). Group 2 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  24. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  25. Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)

    Time frame: 30 days after the vaccination with Menveo® vaccine at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  26. Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccinations With Menveo® Vaccine: Group 2 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination, at the age of 2 months), 30 days after vaccination with Menveo® vaccines at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at 2 months of age). Infant series here denotes the vaccines administered at the age of 6 months of participants.

  27. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Group 2 data were presented separately.

  28. Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Group 2 data were presented separately.

  29. Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine: Groups 1 and 3

    Time frame: Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 6 months) to pre-dose titer at Day 0 (i.e., before the first vaccination, at the age of 2 months). Group 2 data were presented separately.

  30. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 3

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)

    The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >=1:8. Group 2 data were presented separately.

  31. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Antibodies Following Last Vaccination With Menveo® Vaccine: Group 2

    Time frame: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.

  32. Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2

    Time frame: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.

  33. Percentage of Participants With >=4-Fold Rise in Antibody Titers Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Menveo® Vaccine: Group 2

    Time frame: Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Fold-rise was calculated as ratio of post-vaccination titer (i.e., 30 days after the vaccination at the age of 12 months) to pre-dose titer at Day 0 (i.e., before first vaccination, at the age of 2 months).

  34. Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With Menveo® Vaccine: Group 2

    Time frame: 30 days after the vaccination with Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)

    The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >=1:8.

  35. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by Serum Bactericidal Assay Using Baby Rabbit Complement Following MenACYW Conjugate or Menveo® Vaccine: Groups 1 and 2 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination, at the age of 2 months), 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Group 3 data were presented separately. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  36. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following MenACYW Conjugate Vaccine: Group 3 (up to the Infant Age of 6 Months)

    Time frame: Day 0 (before the first vaccination, at the age of Month 2), 30 days after the vaccination of MenACYW Conjugate vaccine at the age of 6 months (i.e., at the age of 7 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using rabbit complement (rSBA). Titers were expressed in terms of 1/dilution. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  37. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Groups 1 and 2

    Time frame: 30 days after the vaccination with MenACYW Conjugate or Menveo® vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution. Group 3 data were presented separately.

  38. Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA Following Last Vaccination With MenACYW Conjugate Vaccine or Menveo® Vaccine: Group 3

    Time frame: 30 days after the vaccination with MenACYW Conjugate vaccine at the age of 12 months (i.e., at the age of 13 months)

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by rSBA. Titers were expressed in terms of 1/dilution.

  39. Number of Participants With Solicited Injection Site Reactions After Any and Each Vaccination

    Time frame: Within 7 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)

    SR: expected AR (sign/symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in protocol & CRF. Injection site reactions were tenderness, erythema & swelling. Assessment of injection site reactions after MenACYW Conjugate vaccine, Menveo, Prevnar 13, Hexacima, MMR, Pentaxim & ENGERIX-B allowed local reactogenicity assessment & helped to identify injection site reaction per vaccine received. Here, for Groups (Gps) 2 & 4: "0" in number analyzed for MenACYW vaccine (Vac.) categories signifies that no participant were evaluable; for Gps 1, 3 & 4: "0" in number analyzed for Menveo Vac. categories signifies that no participant were evaluable; for Gps 3 and 4: '0' in number analyzed field of Hexacima Vac. categories signifies that no participant were evaluable; for Gps 1 and 2: '0' in number analyzed field of Pentaxim and ENGERIX-B Vac. categories signifies that no participant were evaluable, as specified vaccines were not administered in specified groups.

  40. Number of Participants With Solicited Systemic Reactions After Any and Each Vaccination

    Time frame: Within 7 days after any vaccination and each vaccination (i.e., at the age of 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)

    A solicited reaction (SR) was an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. Reported AEs for each arm were presented as pre-specified in the study protocol.

  41. Number of Participants With Unsolicited Adverse Events After Any and Each Vaccination

    Time frame: Within 30 days after any vaccination and each vaccination (i.e., at the age 2 months, 3 months, 4 months, 4.5 months, 6 months and 12 months)

    An AE was any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.

  42. Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESIs)

    Time frame: From Day 0 (i.e., before first vaccination, at the age of 2 months) up to 30 days post last vaccination at the age of 12 months in each Group (i.e., up to the age of 13 months)

    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an event for which ongoing monitoring and rapid communication by the Investigator to the Sponsor must be done. Such an event might warrant further investigation in order to characterize and understand it. Depending on the nature of the event, rapid communication by the study Sponsor to other parties (e.g, regulators) might also be warranted. Reported AEs for each arm were presented as pre-specified in the study protocol.

  43. Percentage of Participants With hSBA Titers Distribution Less Than (<) 1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3 (up to Infant Age of 6 Months)

    Time frame: 30 days after the vaccination at the age of 6 months of the infant series (i.e., at the age of 7 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution < 1:4, 1:4 and 1:8 is reported in this outcome measure. Infant series here denotes the vaccines administered at the age of 6 months of participants.

  44. Percentage of Participants With hSBA Titers Distribution <1:4, 1:4 and 1:8 Against Meningococcal Serogroups A, C, Y, and W Following Last Vaccination With MenACYW Conjugate or Menveo® Vaccine: Groups 1, 2 and 3

    Time frame: 30 days after the vaccination at the age of 12 months (i.e., at the age of 13 months)

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Percentage of participants with hSBA Titers distribution < 1:4, 1:4 and 1:8 is reported in this outcome measure.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Acronym: MET33

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2018
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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