Duration of Protection: GSK DTaP Vaccines
Trial overview
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Timeframe: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Timeframe: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Timeframe: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Timeframe: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
- Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
- The 5th dose was given between the ages of 47 and 84 months.
- Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
- Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
- The 5th dose was given between the ages of 47 and 84 months.
- All 5 DTaP doses received were manufactured by GSK, depending on study objective (otherwise this criterion will not apply).
- Born in 1999 and later. Inclusion criteria for cases:
- All individuals meeting above inclusion criteria who tested PCR-positive for pertussis and negative for parapertussis during the study period. Inclusion criteria for PCR-negative controls:
- All individuals meeting above inclusion criteria who tested PCR-negative for both pertussis and parapertussis during the study period. Inclusion criteria for KPNC-matched controls:
- All individuals from the general KPNC population meeting above inclusion criteria who match a PCR-positive case on sex, age, race or ethnic group, and medical center.
- KPNC members on the day their matched case under-went the PCR test (anchor date).
Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
- Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
- Individuals who received reduced antigen content pertussis vaccine (Tdap) or any pertussis-containing vaccine after their 5th DTaP dose but before their PCR test date (or anchor date). Exclusion criteria for controls:
- Individuals will be excluded from serving as a control once they test positive for pertussis.
Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.