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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01277705
Other study ID # 711866/003
Secondary ID
Status Completed
Phase Phase 3
First received January 13, 2011
Last updated September 6, 2016
Start date January 2002
Est. completion date April 2002

Study information

Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®


Recruitment information / eligibility

Status Completed
Enrollment 806
Est. completion date April 2002
Est. primary completion date April 2002
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination.

- Written informed consent obtained.

- Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge.

- Female subjects must not be pregnant or lactating.

Exclusion Criteria:

- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.

- History of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years.

- French subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.

- German subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup.

- German subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.

- Administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination.

- Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination.

- Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.

- Any confirmed or suspected immunosuppressive or immunodeficient condition,

- History of seizures or progressive neurological disease.

- Major congenital defects or serious chronic illness.

- Acute disease at the time of enrolment.

- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).

- The following adverse experiences associated with diphtheria-tetanus-pertussis vaccination constitute absolute contraindications to further administration of diphtheria-tetanus-pertussis vaccine; if any of these adverse experiences occurred following previous vaccinations, the subject should not be included:

Absolute contraindications:

- Hypersensitivity reaction due to the vaccine.

- Encephalopathy

Precautions:

- Fever >= 40.0°C within 48 hours of vaccination not due to another identifiable cause.

- Collapse or shock-like state within 48 hours of vaccination.

- Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.

- Seizures with or without fever occurring within 3 days of vaccination.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Intramuscular, single
Boostrix™
Intramuscular, single dose
GSK Biologicals' IPV vaccine
Intramuscular, single dose
Revaxis®
Intramuscular, single dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

References & Publications (3)

Grimprel E, von Sonnenburg F, Sänger R, Abitbol V, Wolter JM, Schuerman LM. Combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and polio vaccine (dTpa-IPV) for booster vaccination of adults. Vaccine. 2005 May 25;23(28):3657-67. — View Citation

Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix(®)) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28. — View Citation

Wolter J et al. Boostrix polio: A new combined vaccine to fulfill emerging needs for pertussis vaccination of older age-groups. Abstract presented at the ESPID, Tampere, Finland, 26-28 May 2004.

Outcome

Type Measure Description Time frame Safety issue
Primary Immunogenicity with respect to components of the study vaccines One month after vaccination (Month 1) No
Secondary Immunogenicity with respect to components of the study vaccines One month after vaccination (Month 1) No
Secondary Immunogenicity with respect to some component of the study vaccines At Day 10 after vaccination No
Secondary Occurrence of solicited local and general symptoms within 15 (Day 0-14) days after vaccination No
Secondary Occurrence of unsolicited symptoms within 30 days (Day 0-29) after vaccination No
Secondary Occurrence of serious adverse events Throughout the entire study (from Day 0 to Day 30) No
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