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
  Purpose

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®


Condition Intervention Phase
Poliomyelitis
Diphtheria
Pertussis
Tetanus
Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Biological: Boostrix™
Biological: GSK Biologicals' IPV vaccine
Biological: Revaxis®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 806
Study Start Date: January 2002
Study Completion Date: April 2002
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Intramuscular, single
Experimental: Group B Biological: Boostrix™
Intramuscular, single dose
Biological: GSK Biologicals' IPV vaccine
Intramuscular, single dose
Active Comparator: Group C Biological: Revaxis®
Intramuscular, single dose

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277705

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT01277705     History of Changes
Other Study ID Numbers: 711866/003
Study First Received: January 13, 2011
Last Updated: January 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Booster vaccination

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on July 29, 2014