Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®

NCT ID: NCT01277705

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 806 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2002-04-30

Brief Summary

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®

Conditions

Tetanus; Diphtheria; Acellular Pertussis

Study Design

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

Study Groups

Group A

Group Type: EXPERIMENTAL

GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single

Group B

Group Type: EXPERIMENTAL

Boostrix™

Intervention Type: BIOLOGICAL

Intramuscular, single dose

GSK Biologicals' IPV vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Group C

Group Type: ACTIVE_COMPARATOR

Revaxis®

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Interventions

GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine

Intramuscular, single

Intervention Type: BIOLOGICAL

Boostrix™

Intramuscular, single dose

Intervention Type: BIOLOGICAL

GSK Biologicals' IPV vaccine

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Revaxis®

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination.
• Written informed consent obtained.
• Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge.
• Female subjects must not be pregnant or lactating.

Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
• History of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years.
• French subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
• German subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup.
• German subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
• Administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination.
• Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition,
• History of seizures or progressive neurological disease.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• The following adverse experiences associated with diphtheria-tetanus-pertussis vaccination constitute absolute contraindications to further administration of diphtheria-tetanus-pertussis vaccine; if any of these adverse experiences occurred following previous vaccinations, the subject should not be included:

Absolute contraindications:

• Hypersensitivity reaction due to the vaccine.
• Encephalopathy

Precautions:

• Fever >= 40.0°C within 48 hours of vaccination not due to another identifiable cause.
• Collapse or shock-like state within 48 hours of vaccination.
• Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
• Seizures with or without fever occurring within 3 days of vaccination.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28.

Reference Type: BACKGROUND

PMID: 21718738 (View on PubMed)

Grimprel E, von Sonnenburg F, Sanger R, Abitbol V, Wolter JM, Schuerman LM. Combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and polio vaccine (dTpa-IPV) for booster vaccination of adults. Vaccine. 2005 May 25;23(28):3657-67. doi: 10.1016/j.vaccine.2005.02.013.

Reference Type: RESULT

PMID: 15882526 (View on PubMed)

Wolter J et al. Boostrix polio: A new combined vaccine to fulfill emerging needs for pertussis vaccination of older age-groups. Abstract presented at the ESPID, Tampere, Finland, 26-28 May 2004.

Reference Type: RESULT

Kovac M, Rathi N, Kuriyakose S, Hardt K, Schwarz TF. Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults. Vaccine. 2015 May 21;33(22):2594-601. doi: 10.1016/j.vaccine.2015.03.104. Epub 2015 Apr 14.

Reference Type: DERIVED

PMID: 25882172 (View on PubMed)

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: 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: Study Protocol

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

Related Links

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Other Identifiers

711866/003

Identifier Type: -

Identifier Source: org_study_id