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®

NCT01277705 | Completed Phase 3

• 1 other identifier: 711866/003
• Study Type: interventional
• Target: 806
• Locations: 0 countries
• Sites: N/A

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

Keywords

Booster vaccination

Outcome Measures

Primary Outcomes (1)

• Immunogenicity with respect to components of the study vaccines

  One month after vaccination (Month 1)

Secondary Outcomes (5)

• Immunogenicity with respect to components of the study vaccines

  One month after vaccination (Month 1)

• Immunogenicity with respect to some component of the study vaccines

  At Day 10 after vaccination

• Occurrence of solicited local and general symptoms

  within 15 (Day 0-14) days after vaccination

• Occurrence of unsolicited symptoms

  within 30 days (Day 0-29) after vaccination

• Occurrence of serious adverse events

  Throughout the entire study (from Day 0 to Day 30)

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

Biological: Boostrix™; Biological: GSK Biologicals' IPV vaccine

Group C

ACTIVE COMPARATOR

Biological: Revaxis®

Interventions

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

Intramuscular, single

Group A

Boostrix™ BIOLOGICAL

Intramuscular, single dose

Group B

GSK Biologicals' IPV vaccine BIOLOGICAL

Intramuscular, single dose

Group B

Revaxis® BIOLOGICAL

Intramuscular, single dose

Group C

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (4)

• 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.

  PMID: 21718738 BACKGROUND

• 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.

  PMID: 15882526 RESULT

• 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.

  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.

  PMID: 25882172 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Tetanus; Diphtheria

Interventions

Tetanus Toxoid; Boostrix

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2002
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share