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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®

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Diphtheria
Tetanus
Acellular Pertussis

Treatments

Biological: GSK Biologicals' IPV vaccine
Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Biological: Revaxis®
Biological: Boostrix™

Study type

Interventional

Funder types

Industry

Identifiers

NCT01277705
711866/003

Details and patient eligibility

About

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®

Enrollment

806 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

806 participants in 3 patient groups

Group A
Experimental group
Treatment:
Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Group B
Experimental group
Treatment:
Biological: GSK Biologicals' IPV vaccine
Biological: Boostrix™
Group C
Active Comparator group
Treatment:
Biological: Revaxis®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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