Duration of Protection: GSK DTaP Vaccines

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Diphtheria
Tetanus
Acellular Pertussis

Treatments

Biological: Pediarix
Biological: Infanrix
Biological: Kinrix

Study type

Observational

Funder types

Industry

Identifiers

NCT02447978
201477

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

47 months to 15 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

1 participants in 3 patient groups

PCR-positive pertussis cases
Description:
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.
Treatment:
Biological: Kinrix
Biological: Infanrix
Biological: Pediarix
PCR-negative pertussis controls
Description:
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.
Treatment:
Biological: Kinrix
Biological: Infanrix
Biological: Pediarix
KPNC-matched controls
Description:
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).
Treatment:
Biological: Kinrix
Biological: Infanrix
Biological: Pediarix

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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