Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00489970

First received: June 21, 2007

Last updated: September 21, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 21, 2007

Last Updated Date

September 21, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Anti-D cut-off was defined as greater than or equal to 0.1 international units per mililiter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA).
Number of Subjects With Anti-diphtheria (Anti-D) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Anti-T cut-off was defined as greater than or equal to 0.1 IU/mL.
Number of Subjects With Anti-tetanus (Anti-T) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00489970 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
The cut-off for anti-PT concentrations was defined as equal to or greater than 5 ELISA units per mililiter (EL.U/mL).
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 ] [ Designated as safety issue: No ]
The cut-off for anti-FHA concentrations was defined as equal to or greater than 5 EL.U/mL.
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 ] [ Designated as safety issue: No ]
The cut-off for anti-PRN concentrations was defined as equal to or greater than 5 EL.U/mL.
Anti-D Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
Anti-D antibody concentration is expressed as geometric mean concentration (GMC) in IU/mL.
Anti-T Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
Anti-T antibody concentration is expressed as GMC in IU/mL.
Anti-PT Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
Anti-PT antibody concentration is expressed as GMC in EL.U/mL.
Anti-FHA Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
Anti-FHA antibody concentration is expressed as GMC in EL.U/mL.
Anti-PRN Antibody Concentration [ Time Frame: 1, 3 and 5 years following vaccination ] [ Designated as safety issue: No ]
Anti-PRN antibody concentration is expressed as GMC in EL.U/mL.
Number of Subjects With Anti-pertussis Toxoid (PT) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Number of Subjects With Anti-filamentous Hemagglutinin (FHA) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Number of Subjects With Anti-pertactin (PRN) Antibody Concentrations Equal to or Above Protocol Specified Cut-off [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Anti-D Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Anti-T Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Anti-PT Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Anti-FHA Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]
Anti-PRN Antibody Concentration [ Time Frame: 10 years following vaccination ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Persistence Study of GSK Bio's Tdap Vaccine 1, 3, 5 and 10 Years After Administration as a Single Dose in 106316 Study

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diphtheria
Pertussis
Tetanus

Intervention ^ICMJE

Procedure: 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.
Biological: Boostrix
A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.
Biological: Adacel
A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.

Study Arm (s)

Experimental: Boostrix Group
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.
Interventions:
- Procedure: Taking of blood samples
- Biological: Boostrix
Active Comparator: Adacel Group
Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
Interventions:
- Procedure: Taking of blood samples
- Biological: Adacel

Publications *

Weston W, Messier M, Friedland LR, Wu X, Howe B. Persistence of antibodies 3 years after booster vaccination of adults with combined acellular pertussis, diphtheria and tetanus toxoids vaccine. Vaccine. 2011 Nov 3;29(47):8483-6. Epub 2011 Sep 25.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1592

Estimated Completion Date

September 2016

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00489970

Other Study ID Numbers ^ICMJE

110080, 110082, 110084, 110086

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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