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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®

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277705
First received: January 13, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted

January 13, 2011
January 13, 2011
January 2002
April 2002   (final data collection date for primary outcome measure)
Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to some component of the study vaccines [ Time Frame: At Day 10 after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: within 15 (Day 0-14) days after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: within 30 days (Day 0-29) after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Throughout the entire study (from Day 0 to Day 30) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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®
Assess Immunogenicity, Reactogenicity of GSK Biologicals'-dTpa-IPV Vaccine Versus dTpa & IPV Vaccines Administered Separately & Compared With Aventis Pasteur MSD's Td-IPV Vaccine When Administered to Healthy Adolescents & Adults

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®

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Poliomyelitis
  • Diphtheria
  • Pertussis
  • Tetanus
  • Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
    Intramuscular, single
  • Biological: Boostrix™
    Intramuscular, single dose
  • Biological: GSK Biologicals' IPV vaccine
    Intramuscular, single dose
  • Biological: Revaxis®
    Intramuscular, single dose
  • Experimental: Group A
    Intervention: Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
  • Experimental: Group B
    Interventions:
    • Biological: Boostrix™
    • Biological: GSK Biologicals' IPV vaccine
  • Active Comparator: Group C
    Intervention: Biological: Revaxis®
Grimprel E, von Sonnenburg F, Sänger 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
806
April 2002
April 2002   (final data collection date for primary outcome measure)

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01277705
711866/003
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2011

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