Clinical trial NCT02447978: Duration of Protection: GSK DTaP Vaccines
Official title: Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Acellular Pertussis
Tetanus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 1
Sex: ALL
Minimum age (years): 47
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.

Brief summary: The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.


Eligibility criteria: 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.

Primary outcomes:
measure: Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
timeFrame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
measure: Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
timeFrame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Secondary outcomes:
measure: Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
timeFrame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
measure: Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
timeFrame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.