Duration of Protection: GSK DTaP Vaccines

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447978
• Other study ID #: 201477
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: October 29, 2015
• Start date: February 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 47 Months to 15 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

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.
• 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).
• Kinrix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No