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

Phase 3

Completed

• Conditions: Pertussis; Diphtheria; Tetanus
• Interventions: Biological: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine; Biological: GSK Biologicals' acellular pertussis vaccine; Biological: Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

• Registration Number: NCT01267058
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Primary Completion: 1998-02
• Study Completion: 1998-02
• Status Verified: 2010-12
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-23
• Last Update Submitted: 2010-12-23
• Study First Posted: 2010-12-24
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

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

Exclusion Criteria

• 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
  • fever > 40.5°C (105°F), rectal temperature, occurring after vaccination with diphtheria tetanus pertussis whole-cell vaccine and not due to another identifiable cause.
  • collapse or shock-like state
  • persistent, inconsolable crying lasting > 3 hours
  • seizures with or without fever
  • systemic allergic or neurologic reactions following a previous dose of tetanus and diphtheria toxoids vaccine

• Exclusion from long term follow-up of antibody persistence : Evidence of confirmed pertussis, diphtheria or tetanus disease or vaccination against these diseases since previous study visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine	Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
Group A	GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine	Subjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
Group B	GSK Biologicals' acellular pertussis vaccine	Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
Group B	Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine	Subjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
Group C	GSK Biologicals' acellular pertussis vaccine	Subjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine

Primary Outcome Measures

Name	Time	Method
Occurrence of solicited local and general symptoms	Within the 15-day (Day 0 - Day 14) follow-up period after the first injection

Secondary Outcome Measures

Name	Time	Method
Immunogenicity with respect to components of the study vaccines	2, 3, 4 and 5 years after the vaccination
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
Occurrence of serious adverse experiences to vaccination	Within 31 days (Day 0 - Day 30) after each vaccine administration