Clinical Trial: Duration of Protection: GSK DTaP Vaccines

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children

Brief Summary: The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

• Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine ]
  Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
• Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine ]
  Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine ]
  Estimation derived from comparing PCR-positive cases and matched controls
• Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine ]
  Estimation derived from comparing PCR-positive cases and matched controls

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: March 26, 2015
Date Started: February 2015
Date Completion:
Last Updated: October 29, 2015
Last Verified: October 2015