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Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 4021 |
| Start date | 2007-07 |
| Completion | 2008-11 |
Conditions
- Haemophilus Influenzae Type b
- Neisseria Meningitidis
Interventions
- GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
- PedvaxHIB
- Prevnar
- M-M-R II
- Varivax
Primary outcomes
- Number of Subjects Reporting Serious Adverse Events (SAEs) — From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
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. - Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) — From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. - Number of Subjects Reporting Rash — From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae - Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits — From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
- Number of Subjects With Serious Adverse Events (SAEs) — From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
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. - Number of Subjects With New Onset of Chronic Illnesses (NOCIs) — From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Countries
United States, Mexico