Overview

This trial is active, not recruiting.

Conditions acellular pertussis, tetanus, diphtheria
Treatments taking of blood samples, boostrix, adacel
Phase phase 3
Sponsor GlaxoSmithKline
Start date June 2007
End date September 2007
Trial size 1592 participants
Trial identifier NCT00489970, 110080, 110082, 110084, 110086

Summary

This protocol posting deals with objectives & outcome measures of the extension phase at years 1, 3, 5 and 10. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00346073).

This study will provide information regarding the persistence of antibodies to diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens, up to 10 years following vaccination with GSK Bio's tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination.
boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
(Active Comparator)
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
taking of blood samples
No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination.
adacel
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.

Primary Outcomes

Measure
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 1, 3 and 5 years following vaccination
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 10 years following vaccination
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 1, 3 and 5 years following vaccination
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 10 years following vaccination

Secondary Outcomes

Measure
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 1, 3 and 5 years following vaccination
Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 1, 3 and 5 years following vaccination
Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 1, 3 and 5 years following vaccination
Anti-D Antibody Concentration
time frame: 1, 3 and 5 years following vaccination
Anti-T Antibody Concentration
time frame: 1, 3 and 5 years following vaccination
Anti-PT Antibody Concentration
time frame: 1, 3 and 5 years following vaccination
Anti-FHA Antibody Concentration
time frame: 1, 3 and 5 years following vaccination
Anti-PRN Antibody Concentration
time frame: 1, 3 and 5 years following vaccination
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 10 years following vaccination
Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 10 years following vaccination
Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off
time frame: 10 years following vaccination
Anti-D Antibody Concentration
time frame: 10 years following vaccination
Anti-T Antibody Concentration
time frame: 10 years following vaccination
Anti-PT Antibody Concentration
time frame: 10 years following vaccination
Anti-FHA Antibody Concentration
time frame: 10 years following vaccination
Anti-PRN Antibody Concentration
time frame: 10 years following vaccination

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria: - All subjects who received study vaccination (GSK776423 or Adacel) in the primary study (NCT00346073) will be considered eligible to participate in this study. - Written informed consent must be obtained from the subject prior to each study time point.

Additional Information

Official title A Phase IIIb, Controlled, Multicenter Study to Evaluate Antibody Persistence at 1, 3, 5 and 10 Years Following Administration of a Single Dose of Tdap Vaccine to Healthy Subjects, 19 Years of Age and Older in the Study 106316
Description Open, multicenter study with the same two parallel groups as in the primary study (NCT00346073). No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 10 years after the dose of vaccination. Subjects were randomized (2:1 ratio) in the primary study and will not be further randomized during this persistence phase. This protocol posting is updated in order to comply with the FDA AA, Sep 2007.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.