Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults

NCT01267058 | Completed Phase 3

• 1 other identifier: 263855/002
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.

Conditions

Diphtheria; Pertussis; Tetanus

Keywords

Booster vaccination

Outcome Measures

Primary Outcomes (1)

• Occurrence of solicited local and general symptoms

  Within the 15-day (Day 0 - Day 14) follow-up period after the first injection

Secondary Outcomes (9)

• Immunogenicity with respect to components of the study vaccines

  One month after the first injection

• Immunogenicity with respect to components of the study vaccines

  One month after the second injection

• Occurrence of solicited local symptoms and fever

  Within the 15-day (Day 0 - Day 14) follow-up period after the second injection

• Occurrence of general solicited symptoms to vaccination, other than fever

  Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration

• Occurrence of unsolicited symptoms

  Within 31 days (Day 0 - Day 30) after each vaccine administration

Study Arms (3)

Group A

EXPERIMENTAL

Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine

Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine

Group B

ACTIVE COMPARATOR

Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine

Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

Group C

ACTIVE COMPARATOR

Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine

Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

Interventions

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine BIOLOGICAL

Intramuscular, single dose

Group A

GSK Biologicals' acellular pertussis vaccine BIOLOGICAL

Intramuscular, single dose

Group B; Group C

Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine BIOLOGICAL

Intramuscular, single dose

Group B; Group C

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age at the time of the vaccination
• Written informed consent has been obtained

You may not qualify if:

• Evidence of confirmed pertussis disease within the previous 5 years
• History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
• History of diphtheria or tetanus disease
• History of allergic disease likely to be stimulated by the vaccination
• Major congenital defects or serious chronic illness
• History of progressive neurological disease
• Immunosuppressive therapy
• Any suspected or confirmed immune disorder
• Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
• Acute febrile illness (\>37.5°C, axillary or oral temperature) at the time of planned vaccination
• Administration of an investigational or non registered drug or vaccine within 30 days prior to the start of the present trial
• Simultaneous administration of a vaccine not foreseen by the study protocol, within 30 days prior to the start of the present trial
• Any severe or serious adverse experience having occurred after previous administration of DTP vaccine i.e:
• an immediate anaphylactic or unacceptable reaction to the investigator's opinion, to a previous dose of diphtheria tetanus pertussis whole-cell vaccine, i.e. :
• encephalopathy

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (4)

• Cheuvart B, Burgess M, Zepp F, Mertsola J, Wolter J, Schuerman L. Anti-diphtheria antibody seroprotection rates are similar 10 years after vaccination with dTpa or DTPa using a mathematical model. Vaccine. 2004 Dec 2;23(3):336-42. doi: 10.1016/j.vaccine.2004.06.012.

  PMID: 15530678 BACKGROUND

• 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 BACKGROUND

• Turnbull FM, Heath TC, Jalaludin BB, Burgess MA, Ramalho AC. A randomized trial of two acellular pertussis vaccines (dTpa and pa) and a licensed diphtheria-tetanus vaccine (Td) in adults. Vaccine. 2000 Nov 8;19(6):628-36. doi: 10.1016/s0264-410x(00)00252-8.

  PMID: 11090714 BACKGROUND

• McIntyre PB, Burgess MA, Egan A, Schuerman L, Hoet B. Booster vaccination of adults with reduced-antigen-content diphtheria, Tetanus and pertussis vaccine: immunogenicity 5 years post-vaccination. Vaccine. 2009 Feb 11;27(7):1062-6. doi: 10.1016/j.vaccine.2008.11.102. Epub 2008 Dec 16.

  PMID: 19095033 RESULT

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

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 23, 2010
• First Posted: December 24, 2010
• Study Start: September 1, 1997
• Primary Completion: February 1, 1998
• Study Completion: February 1, 1998
• Last Updated: December 24, 2010

Record last verified: 2010-12