An observational study in Diphtheria, Acellular Pertussis and Tetanus, sponsored by GlaxoSmithKline. Completed. Open to participants aged 47 Months to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-01.
Sponsored by GlaxoSmithKline · Observational
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
265 studies on the registry are indexed under Diphtheria; 16 are open to participants now.
This study's enrollment of 1 is below the median of 682 across 23 observational studies indexed under Diphtheria.
Browse Diphtheria studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.
Inclusion Criteria:
Inclusion criteria for cases:
Inclusion criteria for PCR-negative controls:
Inclusion criteria for KPNC-matched controls:
Exclusion Criteria:
Exclusion criteria for controls:
Cases will be all individuals who tested PCR-positive for pertussis and negative for parapertussis during the study period and who received 5 doses of DTaP vaccines (either manufactured by GSK or any brand, depending on study objective) through 84 months of age before testing PCR-positive.
Biological: Infanrix · Biological: Pediarix · Biological: Kinrix
Controls will consist of persons who tested PCR-negative for both pertussis and parapertussis and who received 5 DTaP doses (either manufactured by GSK or any brand, depending on study objective) before testing PCR negative.
Biological: Infanrix · Biological: Pediarix · Biological: Kinrix
Controls will consist of all KPNC members of the same sex, age (year and quarter of birth), race or ethnic group (7 groups; 6 for reported, 1 for imputed), and medical centre as each pertussis case and who were members on the date the case tested PCR-positive (anchor date).
Biological: Infanrix · Biological: Pediarix · Biological: Kinrix
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.
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).
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Time frame: 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)
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Time frame: 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)
Estimation derived from comparing PCR-positive cases and matched controls
Time frame: 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)
Estimation derived from comparing PCR-positive cases and matched controls
Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline