Clinical Trial: Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae A

Brief Summary: The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule

Detailed Summary:
Sponsor: Crucell Holland BV

Current Primary Outcome:

  • Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component [ Time Frame: at 5 months (equivalent to 1 month after the third vaccination) ]
    Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
  • Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component [ Time Frame: at 14 months (equivalent to 12 months after the first vaccination ]
    Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)


Original Primary Outcome:

  • Immunogenicity - seroconversion to each vaccine component [ Time Frame: 1 month after the third vaccination ]
    Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
  • Immunogenicity - seroconversion to each vaccine component [ Time Frame: 1 year after the first vaccination ]
    Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)


Current Secondary Outcome: Safety: Adverse and Serious Adverse Events [ Time Frame: From Day 1 up to 30 days after the third vaccination ]

Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection


Original Secondary Outcome: Same as current

Information By: Crucell Holland BV

Dates:
Date Received: May 26, 2011
Date Started: April 2010
Date Completion:
Last Updated: August 29, 2013
Last Verified: August 2013