Clinical Trial: Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent The primary phase of this study is evaluating the safety 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.
This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Detailed Summary: Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) ]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) [ Time Frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) ]NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
- Number of Subjects Reporting Rash [ Time Frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) ]Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
- Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) [ Time Frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5) ]
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age) ]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.
Original Primary Outcome: Safety: Hib-MenCY-TT vaccine vs monovalent Hib vaccine with respect to AEs post primary vaccination.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: June 26, 2006
Date Started: September 2006
Date Completion:
Last Updated: November 3, 2016
Last Verified: November 2016