Duration of Protection: GSK DTaP Vaccines

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

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

Conditions
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Tetanus, Diphtheria, Acellular Pertussis

Intervention / Treatment
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* Biological: Infanrix
* Biological: Pediarix
* Biological: Kinrix


Participation Criteria
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Eligibility Criteria
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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). Exclusion criteria for controls: • Individuals will be excluded from serving as a control once they test positive for pertussis.

Ages Eligible for Study
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Minimum Age: 47 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCR-positive pertussis cases<br>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<br>* 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.<br>Biological: Pediarix<br>* 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).<br>Biological: Kinrix<br>* Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine<br>|
| PCR-negative pertussis controls<br>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<br>* 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.<br>Biological: Pediarix<br>* 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).<br>Biological: Kinrix<br>* Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine<br>|
| KPNC-matched controls<br>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<br>* 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.<br>Biological: Pediarix<br>* 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).<br>Biological: Kinrix<br>* Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |