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The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCR-positive pertussis cases | 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. |
| |
| PCR-negative pertussis controls | 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. |
| |
| KPNC-matched controls | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) | Estimation derived from comparing PCR-positive cases and matched controls | 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) |
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Inclusion Criteria:
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:
Exclusion Criteria:
Exclusion criteria for controls:
• Individuals will be excluded from serving as a control once they test positive for pertussis.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28506516 | Derived | Klein NP, Bartlett J, Fireman B, Aukes L, Buck PO, Krishnarajah G, Baxter R. Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 2017 Jun 8;35(26):3395-3400. doi: 10.1016/j.vaccine.2017.05.008. Epub 2017 May 12. |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C472675 | PEDIARIX |
| C051021 | DTPP vaccine |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Pediarix | Biological | 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). |
|
| Kinrix | Biological | Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine |
|
Estimation derived from comparing PCR-positive cases and matched controls |
| Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |