Text Size

Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01262924
First received: December 16, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™


Condition Intervention Phase
Diphteria, Tetanus and Pertussis
 Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Biological: Tedivax-Adult™/ Td-Rix™
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and SB Biologicals' Licensed Td Vaccine in Healthy Adults Aged ≥18 Years

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of solicited general adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse experiences [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response [ Time Frame: At pre-vaccination (Day 0) and Month 1 post-vaccination ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: One month after the second and third booster dose (Month 12) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: October 1997
Study Completion Date: December 1998
Primary Completion Date: December 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
dTPa vaccine
 Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Intramuscular, single dose
Experimental: Group B
Pa vaccine
 Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Intramuscular, single dose
Active Comparator: Group C
Tedivax-Adult™/ Td-Rix™
 Biological: Tedivax-Adult™/ Td-Rix™
Intramuscular, single dose or 2 doses (in the annex phase)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female aged ≥18 years at the time of vaccination
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study
  • Written informed consent obtained from the subject
  • If the subject is female, she must be of non-childbearing potential , i.e., either surgically sterilised or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..

Exclusion Criteria:

  • Vaccination against diphtheria and/or tetanus within the previous five years
  • Vaccination against pertussis since childhood
  • History of diphtheria and/or tetanus
  • Known history of pertussis within the previous five years
  • Known exposure to diphtheria or pertussis within the previous five years
  • Known history of non-response to diphtheria, tetanus or pertussis vaccine
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days/ 5 half-lives preceding the dose of study vaccine
  • Administration of chronic immunosuppressants or other immune-modifying drugs within six months/ 5 half-lives of vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before vaccination and ending 30 days after
  • Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration/ administration during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • Pregnant or lactating female
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Hypersensitivity to any component of the vaccines
  • Acute disease at the time of enrolment
  • Oral temperature of ≥37.5°C (99.5°F)
  • Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
  • An immediate anaphylactic reaction
  • Signs of encephalopathy
  • Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
  • Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
  • Collapse or shock-like state within 48 hours of vaccination
  • Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
  • Convulsions with or without fever, occurring within 3 days of vaccination
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262924

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

Publications:

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT01262924     History of Changes
Other Study ID Numbers: 263855/003
Study First Received: December 16, 2010
Last Updated: December 16, 2010
Health Authority: Belgium: Agence Fédérale des Medicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
Booster vaccination

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
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
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013