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