Duration of Protection: GSK DTaP Vaccines

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: Kinrix; Biological: Infanrix; Biological: Pediarix

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: Pediarix

Biological: Kinrix

Biological: Infanrix

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: Pediarix

Biological: Kinrix

Biological: Infanrix

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: Pediarix

Biological: Kinrix

Biological: Infanrix