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Duration of Protection: GSK DTaP Vaccines

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ClinicalTrials.gov Identifier: NCT02447978
Recruitment Status : Completed
First Posted : May 19, 2015
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.

Condition or disease Intervention/treatment
Diphtheria Acellular Pertussis Tetanus Biological: Infanrix Biological: Pediarix Biological: Kinrix

Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Official Title: Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
Study Start Date : February 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: 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

  2. Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: 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


Secondary Outcome Measures :
  1. Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: 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

  2. Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   47 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447978


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02447978    
Other Study ID Numbers: 201477
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: November 1, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Diphtheria
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections