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

Primary Purpose

Diphtheria, Pertussis, Tetanus

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine

GSK Biologicals' acellular pertussis vaccine

Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Booster vaccination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Occurrence of solicited local and general symptoms

Secondary Outcome Measures

Immunogenicity with respect to components of the study vaccines

Occurrence of solicited local symptoms and fever

Occurrence of general solicited symptoms to vaccination, other than fever

Occurrence of unsolicited symptoms

Occurrence of serious adverse experiences to vaccination

Immunogenicity with respect to components of the study vaccines

Full Information

NCT ID

NCT01267058

First Posted

December 23, 2010

Last Updated

December 23, 2010

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01267058

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

September 1997 (undefined)

Primary Completion Date

February 1998 (Actual)

Study Completion Date

February 1998 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Pertussis, Tetanus

Keywords

Booster vaccination

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine

Intervention Description

Intramuscular, single dose

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals' acellular pertussis vaccine

Intervention Description

Intramuscular, single dose

Intervention Type

Biological

Intervention Name(s)

Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine

Intervention Description

Intramuscular, single dose

Primary Outcome Measure Information:

Title

Occurrence of solicited local and general symptoms

Time Frame

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

Secondary Outcome Measure Information:

Title

Immunogenicity with respect to components of the study vaccines

Time Frame

One month after the first injection

Title

Immunogenicity with respect to components of the study vaccines

Time Frame

One month after the second injection

Title

Occurrence of solicited local symptoms and fever

Time Frame

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

Title

Occurrence of general solicited symptoms to vaccination, other than fever

Time Frame

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

Title

Occurrence of unsolicited symptoms

Time Frame

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

Title

Occurrence of serious adverse experiences to vaccination

Time Frame

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

Title

Immunogenicity with respect to components of the study vaccines

Time Frame

Immediately prior to the booster vaccination

Title

Immunogenicity with respect to components of the study vaccines

Time Frame

One year after the vaccination in a subset of subjects from all the groups

Title

Immunogenicity with respect to components of the study vaccines

Time Frame

2, 3, 4 and 5 years after the vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

15530678

Citation

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.

Results Reference

background

PubMed Identifier

14670310

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. doi: 10.1016/j.vaccine.2003.08.012.

Results Reference

background

PubMed Identifier

11090714

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. doi: 10.1016/s0264-410x(00)00252-8.

Results Reference

background

PubMed Identifier

19095033

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.2008.11.102. Epub 2008 Dec 16.

Results Reference

result

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

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