Comparison of GSK Biologicals' Reduced Antigen Diphtheria and Tetanus Toxoids and Acellular Pertussis- Inactivated Poliovirus Vaccine, to BoostrixTM and Inactivated Poliovirus Vaccine Administered Separately and With Revaxis®

Tetanus Clinical Trial

Official title:

Assess Immunogenicity, Reactogenicity of GSK Biologicals'-dTpa-IPV Vaccine Versus dTpa & IPV Vaccines Administered Separately & Compared With Aventis Pasteur MSD's Td-IPV Vaccine When Administered to Healthy Adolescents & Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277705
• Other study ID #: 711866/003
• 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

• Acellular Pertussis
• Diphtheria
• Tetanus
• Whooping Cough

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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.