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Duration of Protection: GSK DTaP Vaccines

Primary Purpose

Diphtheria, Acellular Pertussis, Tetanus

Status

Completed

Phase

Locations

Study Type

Observational

Intervention

Infanrix

Pediarix

Kinrix

About this trial

This is an observational trial for Diphtheria

Eligibility Criteria

47 Months - 15 Years (Child)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

PCR-positive pertussis cases

PCR-negative pertussis controls

KPNC-matched controls

Arm 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.

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.

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).

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Estimation derived from comparing PCR-positive cases and matched controls

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

Estimation derived from comparing PCR-positive cases and matched controls

Full Information

NCT ID

NCT02447978

First Posted

March 26, 2015

Last Updated

October 29, 2015

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02447978

Brief Title

Duration of Protection: GSK DTaP Vaccines

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Acellular Pertussis, Tetanus

7. Study Design

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCR-positive pertussis cases

Arm Description

Arm Title

PCR-negative pertussis controls

Arm Description

Arm Title

KPNC-matched controls

Arm Description

Intervention Type

Biological

Intervention Name(s)

Infanrix

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Pediarix

Intervention Description

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).

Intervention Type

Biological

Intervention Name(s)

Kinrix

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Estimation derived from comparing PCR-positive cases and matched controls

Time Frame

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

Title

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

Description

Estimation derived from comparing PCR-positive cases and matched controls

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

47 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Population Description

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

Sampling Method

Non-Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

28506516

Citation

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.

Results Reference

derived

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Duration of Protection: GSK DTaP Vaccines

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