Diphtheria, Acellular Pertussis, Tetanus
Conditions
Brief summary
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
Interventions
BIOLOGICALInfanrix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Indicated as a 5-dose series in infants and children 6 weeks to 7 years of age.
BIOLOGICALPediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Indicated as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).
BIOLOGICALKinrix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
ALL
Age
47 Months to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * 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).
Exclusion criteria
* 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). * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) | 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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) | 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) | 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 |
Outcome results
None listed