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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00289783 |
This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.
Condition | Intervention | Phase |
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Haemophilus Influenzae Type b Infection Meningococcal Infection |
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine Biological: ActHIB Biological: PedvaxHIB Biological: Prevnar Biological: M-M-R II Biological: Pediarix Biological: Varivax |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity Study to Evaluate 3 Hib-MenCY-TT Vaccine Lots & GSK Biologicals' Hib & N. Meningitidis Serogroups C&Y-Tetanus Toxoid Conjugate Vaccine Combined vs Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6 & 12 to 15 Months |
Enrollment: | 4441 |
Study Start Date: | February 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Primed with 3 doses of Hib-MenCY-TT vaccine Lot A co-administered with Pediarix. Boosted with 1 dose of Hib-MenCY-TT vaccine, with co-administration of M-M-R II and Varivax to all US subjects in Cohort 1.
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Biological: GSK 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.
Biological: Prevnar
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.
Biological: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Biological: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Biological: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
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Group B: Experimental
Primed with 3 doses of Hib-MenCY-TT vaccine Lot B co-administered with Pediarix. Boosted with 1 dose of Hib-MenCY-TT vaccine, with co-administration of M-M-R II and Varivax to all US subjects in Cohort 1
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Biological: GSK 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.
Biological: Prevnar
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.
Biological: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Biological: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Biological: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
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Group D: Active Comparator
Primed with 3 doses of ActHIB co-administered with Pediarix. Boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax to all US subjects in Cohort 1
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Biological: ActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.
Biological: PedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.
Biological: Prevnar
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.
Biological: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Biological: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Biological: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
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Group C: Experimental
Primed with 3 doses of Hib-MenCY-TT vaccine Lot C co-administered with Pediarix. Boosted with 1 dose of Hib-MenCY-TT vaccine, with co-administration of M-M-R II and Varivax to all US subjects in Cohort 1.
|
Biological: GSK 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.
Biological: Prevnar
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.
Biological: M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Biological: Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Biological: Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
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The subjects from this study will participate in one of three cohorts:
Treatment allocation:
Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site. Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB.
During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3. During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3.
The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.
Ages Eligible for Study: | 6 Weeks to 15 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and
Varivax if any of these criteria apply:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 103813, 105067 |
Study First Received: | February 9, 2006 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00289783 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Meningococcal vaccine Meningococcal disease Neisseria meningitidis Hib disease Immunogenicity |
Safety Primary and booster vaccination Infants Children |
Bacterial Infections Haemophilus Influenzae Fondaparinux Neisseria Meningitidis Orthomyxoviridae Infections Healthy Meningococcal Infection Tetanus |
Org 31540 Gram-Negative Bacterial Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Meningococcal Infections Influenza, Human Neisseriaceae Infections |
Bacterial Infections Virus Diseases Communicable Diseases RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections |
Meningococcal Infections Influenza, Human Orthomyxoviridae Infections Infection Gram-Negative Bacterial Infections Neisseriaceae Infections |