Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

NCT ID: NCT00610168

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-01
• Study Completion Date: 2008-04-30

Brief Summary

The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a prior clinical study. Only subjects who received booster vaccination in the previous clinical study are eligible for participation in this study.

Detailed Description

This Protocol Posting has been updated in order to comply with FDA AA, Sep 2007.

Conditions

Acellular Pertussis; Tetanus; Diphtheria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BOOSTRIX I GROUP

Subjects, who had received Boostrix™ vaccine in the primary study (263855/004), received one additional booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Boostrix TM

Intervention Type: BIOLOGICAL

Single booster dose of vaccine

BOOSTRIX II GROUP

Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix™ vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Boostrix TM

Intervention Type: BIOLOGICAL

Single booster dose of vaccine

Interventions

Boostrix TM

Single booster dose of vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

dTpa vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
• Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004.
• A male or female subject, recruited 10 years after booster vaccination in study 263855/004.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
• Written informed consent obtained from the subject.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination or planned administration during the active study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004.
• History of documented diphtheria, tetanus, or pertussis diseases.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Occurrence of any of the following adverse event after a previous administration of a DTP vaccine :

• hypersensitivity reaction to any component of the vaccine,
• encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine,
• fever >= 40°C within 48 hours of vaccination not due to another identifiable cause,
• collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
• convulsions with or without fever, occurring within 3 days of vaccination.
• Acute disease at the time of enrolment.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Turku, , Finland

Countries

Finland

References

He Q et al. Immunity to pertussis 10 years after acellular booster vaccine in adolescence and response to a second dTpa booster in young adults. Abstract presented at the 19th annual european congress of clinical microbiology and infectious diseases, Helsinki, Finland, 16-19 May 2009.

Reference Type: BACKGROUND

Mertsola J, Van Der Meeren O, He Q, Linko-Parvinen A, Ramakrishnan G, Mannermaa L, Soila M, Pulkkinen M, Jacquet JM. Decennial administration of a reduced antigen content diphtheria and tetanus toxoids and acellular pertussis vaccine in young adults. Clin Infect Dis. 2010 Sep 15;51(6):656-62. doi: 10.1086/655825.

Reference Type: BACKGROUND

PMID: 20704493 (View on PubMed)

Mertsola J et al. Decennial administration of reduced-antigen dTpa vaccine in young adults - incidence of solicited local symptoms classified by pre-vaccination antibody concentrations. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Reference Type: BACKGROUND

Mertsola J et al. The immunogenicity and safety of repeated administration of dTpa booster in adolescents and young adults. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

Reference Type: BACKGROUND

Mertsola J et al. The immunogenicity of repeated administration of reduced-antigen-content dTpa booster in adults. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009

Reference Type: BACKGROUND

Mertsola J et al. The safety of repeated administration of Boostrix™, a reduced-antigen-content dTpa booster. Abstract presented at Excellence In Paediatrics (EIP). Florence, Italy, 3-6 December 2009.

Reference Type: BACKGROUND

Mertsola J et al. The safety of repeated administration of reduced-antigen-content dTpa boosters. Abstract presented at WSPID-6th World Congress. Buenos Aires, Argentina, 19-22 November 2009.

Reference Type: BACKGROUND

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

110806

Identifier Type: -

Identifier Source: org_study_id