Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Browse trials for

• Influenza, Human 2,214

Keywords

• Primary and booster vaccination
• Neisseria meningitidis
• Hib disease
• Meningococcal vaccine
• Meningococcal disease
• Children
• Immunogenicity
• Safety
• Infants

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 4,441 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  Menhibrix A Group

  Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

  Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine · Biological: Pediarix · Biological: Prevnar · Biological: M-M-R II · Biological: Varivax

• Experimental
  Menhibrix B Group

  Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

  Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine · Biological: Pediarix · Biological: Prevnar · Biological: M-M-R II · Biological: Varivax

• Experimental
  Menhibrix C Group

  Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

  Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine · Biological: Pediarix · Biological: Prevnar · Biological: M-M-R II · Biological: Varivax

• Experimental
  Menhibrix Group

  Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

  Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine · Biological: Pediarix · Biological: Prevnar · Biological: M-M-R II · Biological: Varivax

• Active comparator
  ActHIB Group

  Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

  Biological: ActHIB · Biological: PedvaxHIB

Interventions

• BiologicalGSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine

  3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

• BiologicalActHIB

  3-dose intramuscular injection at 2, 4 and 6 months of age.

• BiologicalPedvaxHIB

  1 booster dose by intramuscular injection at 12 to 15 months of age.

• BiologicalPediarix

  3-dose intramuscular injection at 2, 4 and 6 months of age.

  Also known as: Infanrix penta

• BiologicalPrevnar

  3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

• BiologicalM-M-R II

  1 booster dose by subcutaneous injection at 12 to 15 months of age.

• BiologicalVarivax

  1 booster dose by subcutaneous injection at 12 to 15 months of age

Primary outcomes

1. Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations

   Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

2. Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

   Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

3. Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

   Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

4. hSBA-MenC Antibody Titers

   Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose

5. hSBA-MenY Antibody Titers

   Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: Prior to the fourth dose vaccination and 42 days after the fourth dose

6. Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

7. Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: 42 days after the fourth dose

8. Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: 42 days after the fourth dose

9. Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)

   The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine

   Time frame: 42 days after the fourth dose

10. Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter

    This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after the fourth dose

11. Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.

    Time frame: 42 days after the fourth dose

12. Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.

    Time frame: 42 days after the fourth dose

13. Number of Subjects With Anti-varicella Titer Equal to or Above 1:5

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.

    Time frame: 42 days after the fourth dose

Secondary outcomes

1. Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

2. Anti-D and Anti-T Antibody Concentrations

   Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

3. Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)

   Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

4. Anti-HBS Antibody Concentrations

   Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL) Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

5. Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

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

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

7. Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)

   This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

8. Anti-poliovirus Types 1, 2 and 3 Titers

   Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

9. Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values

   Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

   Time frame: One month after primary vaccination

10. Anti-PSC and Anti-PSY Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: One month after primary vaccination

11. Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

    Anti-PRP antibody cut-off values assessed were \>=0.15 microgram per milliliter (µg/mL) and \>=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

12. Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

    Anti-PRP antibody cut-off values assessed were \>=0.15 microgram per milliliter (µg/mL) and \>=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

13. Anti-PRP Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

14. Anti-PRP Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

15. Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

    hSBA-MenC/Y antibody cut-off values assessed were \>=1:4 and \>=1:8 The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

16. Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

    hSBA-MenC/Y antibody cut-off values assessed were \>=1:4 and \>=1:8. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

17. hSBA-MenC and hSBA-MenY Antibody Titers

    Titres are expressed as Geometric Mean Titers (GMTs). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

18. hSBA-MenC and hSBA-MenY Antibody Titers

    Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

19. Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

    Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 microgram per milliliter (µg/mL) and \>=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

20. Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

    Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 µg/mL and \>=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

21. Anti-PSC and Anti-PSY Antibodies Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

22. Anti-PSC and Anti-PSY Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and one month after fourth dose vaccination

23. Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value

    Anti-PRP antibody cut-off values assessed were \>=0.15 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

24. Anti-PRP Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course and prior to the fourth dose vaccination

25. Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values

    hSBA-MenC and hSBA-MenY antibody cut-off values assessed were \>=1:4 and \>=1:8. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: One month after the primary vaccination course

26. Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

    Anti-PSC and anti-PSY antibody cut-off values assessed were \>=0.3 µg/mL and \>=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

27. Anti-PSC and Anti-PSY Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

28. Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)

    This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination

29. Anti-PRP Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth vaccination and 42 days after fourth vaccination

30. Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4

    This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination and 42 days after fourth vaccination

31. Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

32. Anti-measles Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

33. Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values

    Anti-mumps antibody cut-off values assessed were \>=28 estimated dose 50 (ED50) and \>=51 ED50. The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

34. Anti-mumps Antibody Titers

    Titers are expressed as Geometric Mean Titers (GMTs). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

35. Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

36. Anti-rubella Antibody Concentrations

    Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

37. Number of Subjects With Anti-varicella Titer Equal to or Above 1:40

    The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

38. Anti-varicella Antibody Titers

    Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: 42 days after fourth vaccination

39. Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40

    anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based.

    Time frame: Prior to the fourth dose vaccination and one month after the fourth dose vaccination

40. Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

    Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

    Time frame: In the 4-day (Day 0-3) follow-up period after primary vaccination course

41. Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

    Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

    Time frame: In the 4-day (Day0-3) follow-up period after the fourth dose

42. Number of Subjects Reporting Solicited Local and General Symptoms

    Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.

    Time frame: Within the 4 days (Day 0-3) following each dose of the primary vaccination course

43. Number of Subjects Reporting Solicited Local and General Symptoms

    Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C

    Time frame: Within the 4 days (Day 0-3) post-vaccination period following the fourth dose

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

    Unsolicited AE covers any AE 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.

    Time frame: Within 31 days (Day 0-30) following the primary vaccination course

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

    Unsolicited AE covers any AE 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.

    Time frame: Within 31 days (Day 0-30) following the fourth dose

46. Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)

    Increased circumferential swelling defined as either swelling with a diameter of \>50 mm or a \>50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).

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

47. Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination

    Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.

    Time frame: Within 43 days (Day 0 through Day 42) after vaccination

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

    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.

    Time frame: From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose

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

    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.

    Time frame: From the fourth dose through the end of the 6-month safety follow-up

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

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

    Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

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

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

    Time frame: From the fourth dose through the end of the 6-month safety follow-up

52. Number of Subjects Reporting Rash

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

    Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

53. Number of Subjects Reporting Rash

    Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

    Time frame: From the fourth dose through the end of the 6-month safety follow-up

54. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

    Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

    Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

55. Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.

    Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

    Time frame: From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

56. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

    Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

    Time frame: From the fourth dose through the end of the 6-month safety follow-up

57. Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits

    Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

    Time frame: From the fourth dose through the end of the 6-month safety follow-up

58. Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).

    This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination

59. Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.

    This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

    Time frame: Prior to the fourth dose vaccination

Baseline characteristics

Publications

• Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. PubMed 21806393 ↗
• Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29. PubMed 21624883 ↗
• Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1. PubMed 22617844 ↗
• Bryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
• Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13. PubMed 22327493 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.