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Completed

NCT Number: NCT01939158

Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

12 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Garran, Australian Capital Territory, Australia

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About this study

The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.

Exclusion criteria

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Previous vaccination against Neisseria meningitidis.
  • Previous booster vaccination against Streptococcus pneumoniae.
  • Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*
  • Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Treatment and study plan

Meningococcal vaccine GSK134612

Biological

1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Prevenar 13™

Biological

1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

Primary outcomes

  1. Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  2. Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

    Time frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  3. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 1

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  4. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 1

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  5. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 3

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  6. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 3

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  7. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 5

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  8. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 5

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  9. Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

    Time frame: 1 month after administration of Prevnar 13 (i.e. at Month 1)

    GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.

Secondary outcomes

  1. Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  2. Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

    Time frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  3. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

    Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  4. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group

    Time frame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

    Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  5. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  6. Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  7. Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  8. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups

    Time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  9. Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 1, Year 3, Year 5

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  10. Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups

    Time frame: At Year 1, Year 3, Year 5

    Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  11. Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

    Time frame: At Year 1, Year 3, Year 5

    Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  12. Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups

    Time frame: At Year 1, Year 3, Year 5

    Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.

  13. Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

    Time frame: 1 month after administration of Prevnar 13 (i.e. at Month 1)

    Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.

  14. Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

    Time frame: 1 month after administration of Prevnar 13 (i.e. at Month 1)

    OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.

  15. Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups

    Time frame: 1 month after administration of Prevnar 13 (i.e. at Month 1)

    OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.

  16. Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination

    Time frame: Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])

    Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category.

  17. Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination

    Time frame: Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])

    Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively.

  18. Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)

    Time frame: Within 31 days post any vaccination

    An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.

  19. Number of Participants With Serious Adverse Events From Month 0 to Month 9

    Time frame: Month 0 to Month 9

    An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.

  20. Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study

    Time frame: Baseline up to end of study (up to 5 years)

    An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.

  21. Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9

    Time frame: Month 0 to Month 9

    New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2013
Registry last updated
Oct 5, 2021

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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