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
Study complete
Study complete
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
    Primary completion date:
    2015-16-06
    Observational study model:
    Other
    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)

    This study does not involve prospective enrollment of participants.

    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
    Study complete
    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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