Duration of Protection: GSK DTaP Vaccines

Completed

• Conditions: Diphtheria; Tetanus; Acellular Pertussis
• Interventions: Biological: Infanrix; Biological: Pediarix; Biological: Kinrix

• Registration Number: NCT02447978
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KPNC-matched controls	Pediarix	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).
PCR-positive pertussis cases	Infanrix	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.
PCR-positive pertussis cases	Pediarix	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.
PCR-negative pertussis controls	Pediarix	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.
PCR-positive pertussis cases	Kinrix	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.
PCR-negative pertussis controls	Infanrix	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.
KPNC-matched controls	Infanrix	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).
KPNC-matched controls	Kinrix	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).
PCR-negative pertussis controls	Kinrix	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.

Primary Outcome Measures

Name	Time	Method
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)	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
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)	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

Secondary Outcome Measures

Name	Time	Method
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)	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
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)	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