Duration of Protection: GSK DTaP Vaccines
Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
1 other identifier
observational
1
0 countries
N/A
Brief Summary
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2015
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 2, 2015
October 1, 2015
4 months
March 26, 2015
October 29, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
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
Study Arms (3)
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).
Interventions
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
Eligibility Criteria
Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.
You may qualify if:
- 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.
- KPNC members on the day their matched case under-went the PCR test (anchor date).
You may not qualify if:
- 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).
- Individuals will be excluded from serving as a control once they test positive for pertussis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (1)
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.
PMID: 28506516DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
May 19, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 2, 2015
Record last verified: 2015-10