CompletedNCT01262924Updated Dec 17, 2010

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

A Phase 3 interventional study of GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine and GSK Biologicals' reduced-antigen-content acellular pertussis vaccine in Diphteria, Tetanus and Pertussis, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-17.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 116
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Diphteria, Tetanus and Pertussis

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Keywords

Booster vaccination

In context

Whooping Cough

238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.

This study's enrollment of 116 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.

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Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

For the annex phase of this study, subjects must meet the inclusion criteria mentioned above. In addition, subjects must have received either reduced-antigen-content diphtheria-tetanus or diphtheria-tetanus-acellular pertussis vaccine in the initial phase of the study and not responded to either the diphtheria or tetanus toxoid..

Exclusion criteria

Exclusion Criteria:

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
Oral temperature of ≥37.5°C (99.5°F)
Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine or diptheria and tetanus vaccines
An immediate anaphylactic reaction
Signs of encephalopathy
Any of the following having occurred after previous administration of diphtheria-tetanus-pertussis vaccine alone or in combination with other antigens:
Rectal temperature ≥40.5°C within 48 hours of vaccination and not due to another identifiable cause
Collapse or shock-like state within 48 hours of vaccination
Persistent, inconsolable screaming or crying lasting ≥3 hours within 48 hours of vaccination
Convulsions with or without fever, occurring within 3 days of vaccination

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 116 participants (actual)

Study arms

Experimental
Group A
dTPa vaccine
Biological: GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Experimental
Group B
Pa vaccine
Biological: GSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Active comparator
Group C
Tedivax-Adult™/ Td-Rix™
Biological: Tedivax-Adult™/ Td-Rix™

Interventions

BiologicalGSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine
Intramuscular, single dose
BiologicalGSK Biologicals' reduced-antigen-content acellular pertussis vaccine
Intramuscular, single dose
BiologicalTedivax-Adult™/ Td-Rix™
Intramuscular, single dose or 2 doses (in the annex phase)

What researchers measure

Primary outcomes

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)

Secondary outcomes

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
Time frame: One month after the booster dose (Month 1)
Occurrence of solicited local adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of solicited general adverse experiences
Time frame: During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of unsolicited symptoms
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Occurrence of any serious adverse experiences
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination
Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response
Time frame: At pre-vaccination (Day 0) and Month 1 post-vaccination
Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: One month after the second and third booster dose (Month 12)
Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose
Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose
Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose)
Time frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 14670310 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01262924
Lead sponsor: GlaxoSmithKline
First posted: Dec 17, 2010
Start date: Oct 1997
Primary completion: Dec 1998
Completion: Dec 1998
Last update: Dec 17, 2010

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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