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

Tetanus Clinical Trial

Official title:

Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267058
• Other study ID #: 263855/002
• Status: Completed
• Phase: Phase 3
• First received: December 23, 2010
• Last updated: December 23, 2010
• Start date: September 1997
• Est. completion date: February 1998

Study information

• Verified date: December 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: February 1998
• Est. primary completion date: February 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine
Intramuscular, single dose
• GSK Biologicals' acellular pertussis vaccine
Intramuscular, single dose
• Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine
Intramuscular, single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited local and general symptoms		Within the 15-day (Day 0 - Day 14) follow-up period after the first injection	No
Secondary	Immunogenicity with respect to components of the study vaccines		One month after the first injection	No
Secondary	Immunogenicity with respect to components of the study vaccines		One month after the second injection	No
Secondary	Occurrence of solicited local symptoms and fever		Within the 15-day (Day 0 - Day 14) follow-up period after the second injection	No
Secondary	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	No
Secondary	Occurrence of unsolicited symptoms		Within 31 days (Day 0 - Day 30) after each vaccine administration	No
Secondary	Occurrence of serious adverse experiences to vaccination		Within 31 days (Day 0 - Day 30) after each vaccine administration	No
Secondary	Immunogenicity with respect to components of the study vaccines		Immediately prior to the booster vaccination	No
Secondary	Immunogenicity with respect to components of the study vaccines		One year after the vaccination in a subset of subjects from all the groups	No
Secondary	Immunogenicity with respect to components of the study vaccines		2, 3, 4 and 5 years after the vaccination	No