Meningococcal Infection Clinical Trial
Official title:
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.
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis
serogroups C and Y-tetanus toxoid conjugate vaccine.
The study will be conducted in a single blind manner up to 30 days after administration of
the booster dose; the extended safety follow-up after the booster dose will be conducted in
an unblinded manner.
All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially
co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.
Note: This protocol posting deals with the objectives & outcome measures for the booster
phase of the study. The objectives & outcome measures for the primary phase are presented in
a separate protocol posting (NCT00345579)
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention
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