Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1 participants
OBSERVATIONAL
2015-02-28
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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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.
Infanrix
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.
Pediarix
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
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
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.
Infanrix
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.
Pediarix
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
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
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).
Infanrix
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.
Pediarix
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
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
Interventions
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Infanrix
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.
Pediarix
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
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
Eligibility Criteria
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Inclusion Criteria
* 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.
* KPNC members on the day their matched case under-went the PCR test (anchor date).
Exclusion Criteria
* 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).
• Individuals will be excluded from serving as a control once they test positive for pertussis.
47 Months
15 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
References
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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.
Other Identifiers
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201477
Identifier Type: -
Identifier Source: org_study_id
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