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OpenTrials
Completed

NCT Number: NCT02447978

Duration of Protection: GSK DTaP Vaccines

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infanrix

Biological

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

Biological

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

Biological

Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine

Primary outcomes

  1. Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)

    Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine

    Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls

  2. Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)

    Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine

    Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls

Secondary outcomes

  1. Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)

    Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine

    Estimation derived from comparing PCR-positive cases and matched controls

  2. Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)

    Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine

    Estimation derived from comparing PCR-positive cases and matched controls

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 19, 2015
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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