Last updated: 06/26/2019 11:41:34

Duration of Protection: GSK DTaP Vaccines

GSK study ID
201477
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Duration of Protection Following Five Doses of GlaxoSmithKline’s (GSK’s) DTaP Vaccines in School Age Children
Trial description: The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

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:

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

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

Interventions:
Biological/vaccine: Infanrix
Biological/vaccine: Pediarix
Biological/vaccine: Kinrix
Enrollment:
1
Observational study model:
Other
Primary completion date:
2015-16-06
Time perspective:
Other
Clinical publications:
Klein NP et al. (2017) Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 35(26):3395-3400.
Medical condition
Diphtheria, acellular pertussis, Tetanus, Diphtheria-Tetanus-acellular Pertussis Vaccines
Product
GSK2647153A
Collaborators
Not applicable
Study date(s)
February 2015 to June 2015
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
47 months - 15 years
Accepts healthy volunteers
Yes
  • 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.
  • 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).

Trial location(s)

No location data available.

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2015-16-06
Actual study completion date
2015-16-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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