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

NCT01262924 | Completed Phase 3

• 1 other identifier: 263855/003
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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™

Conditions

Diphteria, Tetanus and Pertussis

Keywords

Booster vaccination

Outcome Measures

Primary Outcomes (1)

• Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)

  One month after the booster dose (Month 1)

Secondary Outcomes (11)

• Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)

  One month after the booster dose (Month 1)

• Occurrence of solicited local adverse experiences

  During the 15-day (Day 0-14) follow-up period after vaccination

• Occurrence of solicited general adverse experiences

  During the 15-day (Day 0-14) follow-up period after vaccination

• Occurrence of unsolicited symptoms

  Within the 31-day (Day 0 -30) follow-up period after vaccination

• Occurrence of any serious adverse experiences

  Within the 31-day (Day 0 -30) follow-up period after vaccination

Study Arms (3)

Group A

EXPERIMENTAL

dTPa vaccine

Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine

Group B

EXPERIMENTAL

Pa vaccine

Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccine

Group C

ACTIVE COMPARATOR

Tedivax-Adult™/ Td-Rix™

Biological: Tedivax-Adult™/ Td-Rix™

Interventions

GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine BIOLOGICAL

Intramuscular, single dose

Group A

GSK Biologicals' reduced-antigen-content acellular pertussis vaccine BIOLOGICAL

Intramuscular, single dose

Group B

Tedivax-Adult™/ Td-Rix™ BIOLOGICAL

Intramuscular, single dose or 2 doses (in the annex phase)

Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Van Damme P, Burgess M. Immunogenicity of a combined diphtheria-tetanus-acellular pertussis vaccine in adults. Vaccine. 2004 Jan 2;22(3-4):305-8. doi: 10.1016/j.vaccine.2003.08.012.

  PMID: 14670310 RESULT

MeSH Terms

Conditions

Tetanus; Whooping Cough

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: October 1, 1997
• Primary Completion: December 1, 1998
• Study Completion: December 1, 1998
• Last Updated: December 17, 2010

Record last verified: 2010-12