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OpenTrials
Completed

NCT Number: NCT00129129

Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine

This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, each administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age. The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.

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Key information

Conditions

Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Infections Meningococcal Infections Neisseria Meningitidis Neisseriaceae Infections Pasteurellaceae Infections

Age range

6 week–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Little Rock, Arkansas, United States

Loading trial locations.

About this study

The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the MenC and MenY antigens will be summarized.

MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A, C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3 to 5 years of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • For Groups A and B
  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • Healthy male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering the study.
  • Born after a gestation period between 36 and 42 weeks.
  • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
  • For Group C
  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • Healthy male or female between, and including, 3 and 5 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering the study.

Exclusion criteria

-For Groups A and B

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliovirus, and/or Streptococcus pneumoniae; more than one previous dose of hepatitis B vaccine.
  • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and/or Streptococcus pneumoniae disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

For Group C

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the dose of study vaccine.
  • Previous vaccination against Neisseria meningitidis.
  • History of Neisseria meningitidis disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including dry natural latex rubber
  • Major congenital defects or serious chronic illness.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during the study period.

Treatment and study plan

GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine

Biological

Primary phase: 3 IM doses Booster phase: 1 IM dose

ActHIB

Biological

Primary phase: 3 IM doses Booster phase: 1 IM dose

Pediarix

Biological

Primary phase: 3 IM doses

Prevnar

Biological

Primary phase: 3 IM doses Booster phase: 1 IM dose

Menomune

Biological

Primary phase: 1 SC dose

Primary outcomes

  1. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value.

    Time frame: One month after the 3-dose primary vaccination course (at Month 5)

    The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  2. Concentration of Antibodies Against Streptococcus Pneumoniae Serotypes

    Time frame: One month after the 3-dose primary vaccination course (at Month 5)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  3. Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations

    Time frame: One month after the 3-dose primary vaccination course (at Month 5)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  4. Number of Subjects Reporting Any Grade 3 Symptoms

    Time frame: During the 4-day follow-up period after each primary vaccine dose

    "Symptoms" were defined as solicited local and general symptoms and unsolicited adverse events (AEs). A "Grade 3" symptom was defined as any symptom that prevented normal everyday activity. "Any" was defined as an occurrence of any specified symptom regardless of intensity grade. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  5. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value

    Time frame: One month after the fourth dose (at Month 11-14)

    The anti-PRP antibody cut-off value used for this outcome was 1.0 microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB/ActHIB groups .

Secondary outcomes

  1. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers ≥ the Cut-off Values

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    rSBA-MenC antibody cut-off values for this outcome were 1:8 and 1:128.

  2. Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Titers are presented as geometric mean titers (GMTs).

  3. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers ≥ the Cut-off Values

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    rSBA-MenY antibody cut-off values for this outcome measure were 1:8 and 1:128.

  4. Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Titers are presented as geometric mean titers (GMTs).

  5. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4

    Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

    A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.

  6. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers ≥ 1:4

    Time frame: One month after the primary vaccination course (at Month 5 for the MenHibrix and ActHIB groups)/one month after vaccination (at Month 1 for the Menomune Group)

    A composite outcome variable was formulated as follows for this immunogenicity analysis outcome: hSBA-Men titers ≥ 1:4 for subjects with post-vaccination rSBA-Men antibody titers ≥ 1:8 and lower than (<) 1:128.

  7. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above ≥ the Cut-off Values

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Anti-PSC antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

  8. Anti-polysaccharide C (Anti-PSC) Antibody Concentrations

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

  9. Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above ≥ the Cut-off Values

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Anti-PSY antibody cut-off values for this outcome were 0.3 µg/mL and 2.0 µg/mL.

  10. Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5 for the MenHibrix and ActHIB groups)/ prior to and one month after vaccination (at Day 0 and Month 1 for the Menomune Group)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

  11. Number of Subjects Reporting Medically Attended Visits

    Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

    A medically attended visit was defined as an hospitalization, an emergency room visit or a visit to or from medical personnel. This Outcome Measure only concerns subjects in the Menomune Group.

  12. Number of Subjects Reporting Rash

    Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns subjects in the Menomune Group.

  13. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: During the 31-day follow-up period after vaccination with Menomune vaccine at Day 0

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject . This Outcome Measure only concerns subjects in the Menomune Group.

  14. Number of Subjects With Anti-PRP Antibody Concentrations ≥ the Cut-off Values

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    Anti-PRP antibody cut-off values for this outcome were 0.15 µg/mL and 1.0 µg/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  15. Anti-PRP Antibody Concentrations

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  16. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.05 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  17. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.2 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups

  18. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations ≥ Cut-off

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    The Streptococcus pneumoniae antibody cut-off value for this outcome was 0.5 µg/mL for the 7 serotypes in Prevnar vaccine. Prevnar vaccine pneumococcal serotypes included the serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  19. Number of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentration ≥ 0.1 International Units Per Milliliter (IU/mL)

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    The anti-diphtheria and anti-tetanus antibody cut-off value for this outcome was ≥ 0.1 IU/mL. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

  20. Anti-diphtheria and Anti-tetanus Antibody Concentrations

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  21. Number of Subjects With Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentration ≥ 10.0 Milli-international Units Per Milliliter (mIU/mL)

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  22. Anti-hepatitis-B Surface Antigen (Anti-HBs) Antibody Concentrations

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  23. Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration ≥ 5.0 EL.U/mL

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  24. Anti PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: Prior to the primary vaccination course (at Day 0)

    Concentrations of antibodies are presented as GMCs expressed as EL.U/mL. Results for one month after the 3-dose primary vaccination course (at Month 5) are presented under the Primary Outcome Measures section. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  25. Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Antibody Titer ≥ 1:8

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  26. Anti-poliovirus Types 1, 2 and 3 Antibody Titers

    Time frame: Prior to and one month after the primary vaccination course (at Day 0 and Month 5)

    Titers are presented as geometric mean titers (GMTs). This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  27. Number of Subjects With Vaccine Response to PT, FHA and PRN

    Time frame: One month after the 3-dose primary vaccination course (at Month 5)

    Vaccine response to PT/FHA/PRN was defined as, for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month post-primary vaccination course, and, for initially seropositive subjects, antibody concentration one month post-primary vaccination course ≥ 1-fold the pre-vaccination antibody concentration. A seronegative/seronegative subject was defined as a subject with antibody concentration </≥ 5 EL.U/mL for anti-PT/FHA/PRN prior to vaccination. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  28. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms

    Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination

    Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  29. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms

    Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination

    Solicited local symptoms were pain, redness and swelling at injection site. "Any" = any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling larger than (>) 10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling > 30 mm. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  30. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms

    Time frame: Within 4 days (Day 0-3) after the 3-dose primary vaccination

    Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  31. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms

    Time frame: Within 8 days (Day 0-7) after the 3-dose primary vaccination

    Solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. "Any" = any report of the specified symptom irrespective of intensity grade and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness and Loss of appetite = symptom that interfered with normal activity; "Grade 3" for Drowsiness and Irritability/Fussiness = symptom that prevented normal activity; "Grade 3" Loss of appetite = not eating at all. Fever = rectal temperature ≥ 38.0 degrees Celsius (°C); "Grade 2 or 3" fever = rectal temperature higher than (>) 39°C; "Grade 3" fever = rectal temperature > 40°C. This Outcome Measure only concerns the MenHibrix and ActHIB groups

  32. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: From Dose 1 (at Day 0) through Day 30 following the last vaccine dose administered (Day 30 post Month 4 vaccination for MenHibrix and ActHIB groups, Day 30 post Month 1 for Menomune Group).

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  33. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: During the entire Primary Phase of the study, from Day 0 up to the end of Primary Phase safety follow-up period (6 months after the last vaccination).

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

  34. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  35. Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs)

    Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  36. Number of Subjects Reporting Rash

    Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae. This Outcome Measure only concerns the MenHibrix and ActHIB groups .

  37. Number of Subjects Reporting Emergency Room (ER) Visits or Visits to Physicians' Office, Related or Not to Common Illnesses

    Time frame: From Day 0 following Dose 1 throughout the study up to the day preceding the administration of the fourth dose of vaccine.

    Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

  38. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)

    Time frame: One month post fourth dose vaccination (at Month 11-14)

    Fourth dose responses to rSBA-MenC and rSBA-MenY were defined as follows (Definition 1):

    • Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after fourth dose (post-fourth dose antibody titer ≥1:32),
    • Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after fourth dose.

  39. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC and Y)

    Time frame: One month post fourth dose vaccination (at Month 11-14)

    Fourth dose responses to rSBA-MenC and rSBA-MenY were also assessed using a second definition (Definition 2):

    • Post-fourth dose rSBA antibody titers ≥1:32 in subjects seronegative at the pre-fourth dose time point (rSBA antibody titers < 1:8),
    • At least (i.e., greater than or equal to) a 4-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8 but < 1:128,
    • At least (i.e., greater than or equal to) a 2-fold rise in rSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:128.

  40. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)

    Time frame: One month post fourth dose vaccination (at Month 11-14)

    Fourth dose responses to hSBA-MenC and hSBA-MenY were defined as follows (Definition 1):

    • Initially seronegative subjects (pre-fourth dose antibody titer below cut-off: < 1:8) should have an antibody titer at least four-fold higher than the cut-off, one month after the fourth dose (post-fourth dose antibody titer ≥1:16),
    • Initially seropositive subjects (pre-fourth dose antibody titer above cut-off: ≥1:8) should have an antibody titer at least four-fold higher than the pre-fourth dose antibody titer, one month after the fourth dose.

  41. Number of Subjects With Fourth Dose Response for Neisseria Meningitidis Serogroup C and Y Serum Bacterial Assay Using Human Complement (hSBA-MenC and Y)

    Time frame: One month post fourth dose vaccination (at Month 11-14)

    Fourth dose responses to hSBA-MenC and hSBA-MenY were also assessed using a second definition (Definition 2):

    • Post-fourth dose hSBA antibody titers ≥1:16 in subjects seronegative at the pre-fourth dose time point (hSBA antibody titers < 1:8),
    • At least (i.e., greater than or equal to) a 4-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:4 but < 1: 8,
    • At least (i.e., greater than or equal to) a 2-fold rise in hSBA antibody titers in subjects with pre-fourth dose antibody titers ≥1:8.

  42. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.05 Microgram Per Milliliter (µg/mL)

    Time frame: One month after fourth dose vaccination (at Month 11-14)

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.05 µg/mL for the 7 serotypes in Prevnar vaccine.

    Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

  43. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.2 Microgram Per Milliliter (µg/mL)

    Time frame: One month after fourth dose vaccination (at Month 11-14)

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.2 µg/mL for the 7 serotypes in Prevnar vaccine.

    Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

  44. Number of Subjects With Streptococcus Pneumoniae Serotypes Antibody Concentrations Equal to or Above 0.5 Microgram Per Milliliter (µg/mL)

    Time frame: One month after fourth dose vaccination (at Month 11-14)

    Streptococcus pneumoniae antibody cut-off values assessed was ≥0.5 µg/mL for the 7 serotypes in Prevnar vaccine.

    Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

  45. Concentration of Antibodies Against Streptococcus Pneumonia Serotypes

    Time frame: One month post fourth dose vaccination (at Month 11-14)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

    Vaccine pneumococcal serotypes included serotypes 4, 6B, 9V, 14, 18C, 19F, 23F.

  46. Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Anti-PRP antibody cut-off values assessed were ≥0.15 µg/mL and ≥1.0 µg/mL.

  47. Anti-PRP Antibody Concentrations

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

  48. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Rabbit Complement (rSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    rSBA-MenC antibody cut-off values assessed were ≥1:8 and ≥1:128

  49. rSBA-MenC Antibody Titers

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Titers are presented as geometric mean titers (GMTs).

  50. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Rabbit Complement (rSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    rSBA-MenY antibody cut-off values assesse were ≥1:8 and ≥1:128.

  51. rSBA-MenY Antibody Titers

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Titers are presented as geometric mean titers (GMTs).

  52. Number of Subjects With Neisseria Meningitidis Serogroup C Serum Bacterial Assay Using Human Complement (hSBA-MenC) Antibody Titers Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    hSBA-MenC antibody cut-off values assessed were ≥1:4 and ≥1:8.

  53. hSBA-MenC Antibody Titers

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Titers are presented as geometric mean titers (GMTs).

  54. Number of Subjects With Neisseria Meningitidis Serogroup Y Serum Bacterial Assay Using Human Complement (hSBA-MenY) Antibody Titers Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    hSBA-MenY antibody cut-off values assessed were ≥1:4 and ≥1:8.

  55. hSBA-MenY Antibody Titers

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Titers are presented as geometric mean titers (GMTs).

  56. Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Anti-PSC antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.

  57. Anti-PSC Antibody Concentrations

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).

  58. Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentrations Equal to or Above the Cut-off Values

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Anti-PSY antibody cut-off values assessed were ≥0.3 µg/mL and ≥2.0 µg/mL.

  59. Anti-PSY Antibody Concentrations

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL)

  60. Number of Subjects With Anti-tetanus Antibody Concentration Equal to or Above 0.1 International Units Per Milliliter (IU/mL)

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

  61. Anti-tetanus Antibody Concentrations

    Time frame: Prior to and one month after the fourth dose (at Month 10-13 and at Month 11-14)

    Concentrations of antibodies are presented as geometric mean concentrations (GMCs) expressed as international units per milliliter (IU/mL).

  62. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms

    Time frame: Within 4 days (Day 0-3) after fourth dose vaccination

    Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm

  63. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited Local Symptoms

    Time frame: Within 8 days (Day 0-7) after fourth dose vaccination

    Solicited symptoms assessed were pain, redness, swelling at the injection site and increase in limb circumference. "Any"= any report of the specified symptom irrespective of intensity grade; "Grade 2 pain" = cried/protested on touch; "Grade 3 pain" = cried when limb was moved/spontaneously painful; "Grade 2 or 3" redness/swelling = redness/swelling >10 millimeters (mm); "Grade 3" redness/swelling = redness/swelling >30 mm; "Grade 2" limb circumference (LC) = LC >20 mm; "Grade 3" LC = LC >40 mm

  64. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms

    Time frame: Within 4 days (Day 0-3) after fourth dose vaccination

    Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C

  65. Number of Subjects Reporting Any, Grade 2 or 3 and Grade 3 Solicited General Symptoms

    Time frame: Within 8 days (Day 0-7) after fourth dose vaccination

    Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness, loss of appetite. "Any"= any report of the specified symptom irrespective of intensity and relationship to vaccination. "Grade 2" for Drowsiness, Irritability/Fussiness & Loss of appetite = interfered with normal activity; "Grade 3" for Drowsiness, Irritability/Fussiness = prevented normal activity; "Grade 3" Loss of appetite = not eating at all; Fever = rectal temperature (T) ≥38.0 degrees Celsius (°C); "Grade 2 or 3" for fever = T >39.0°C; "Grade 3" for fever = T >40.0°C

  66. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: During the 31-day follow-up period following the fourth dose

    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

  67. Number of Subjects Reporting New Onset of Chronic Illness(es)

    Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  68. Number of Subjects Reporting Rash

    Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

    An episode of rash was defined as an episode of hives, idiopathic thrombocytopenic purpura, petechiae.

  69. Number of Subjects Reporting Emergency Room (ER) Visits or Physicians Office Visits Related or Not to Common Illnesses

    Time frame: From receipt of the fourth dose (at Month 10-13) through the end of the 6-month safety follow-up

    Emergency room (ER) visits or physicians office visits assessed were those unrelated to well-child care, vaccination, injury or common acute illnesses such as upper respiratory tract infections, otitis media, pharyngitis, gastroenteritis. This Outcome Measure only concerns the MenHibrix and ActHIB groups.

  70. Number of Subjects Reporting Large Swelling Reactions of the Injected Limb(s)

    Time frame: Within 4 days (Day 0-3) and within 8 days (Day 0-7) following the fourth dose

    Large injection site reactions were defined as either swelling with a diameter of > 30 mm or a > 30 mm increase in the circumference of the mid-thigh when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interfered with or prevented everyday activities (for example, active playing, eating, sleeping).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Evaluate Immuno and Safety of GSKBiologicals' HibMenCYTT vs Licensed Hib Conjugate Vaccine, Each Coadministered With Pediarix® and Prevnar®, in Healthy Infants. An Exploratory Control Group Will Receive Licensed Menomune® at 3 to 5 Years

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Aug 11, 2005
Registry last updated
Aug 24, 2018

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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