Duration of Protection: GSK DTaP Vaccines

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

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

Study Overview

• Status: Completed
• Conditions: Tetanus; Diphtheria; Acellular Pertussis
• Intervention / Treatment: Biological: Infanrix; Biological: Pediarix; Biological: Kinrix

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCR-positive pertussis cases; 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.	Biological: Infanrix; 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.; Biological: Pediarix; 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).; Biological: Kinrix; Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
PCR-negative pertussis controls; 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.	Biological: Infanrix; 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.; Biological: Pediarix; 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).; Biological: Kinrix; Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
KPNC-matched controls; 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).	Biological: Infanrix; 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.; Biological: Pediarix; 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).; Biological: Kinrix; Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)	Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls	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)	Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls	Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)	Estimation derived from comparing PCR-positive cases and matched controls	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)	Estimation derived from comparing PCR-positive cases and matched controls	Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Klein NP, Bartlett J, Fireman B, Aukes L, Buck PO, Krishnarajah G, Baxter R. Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 2017 Jun 8;35(26):3395-3400. doi: 10.1016/j.vaccine.2017.05.008. Epub 2017 May 12.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Estimate): November 1, 2015
• Last Update Submitted That Met QC Criteria: October 29, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Corynebacterium Infections; Diphtheria
• Other Study ID Numbers: 201477