Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

Tetanus Clinical Trial

Official title:

Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294605
• Other study ID #: 263855/034
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2011
• Last updated: September 14, 2016
• Start date: April 2003
• Est. completion date: September 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Minister van VWS Medische TechnologieSpain: Agencia Española del Medicamento y Productos SanitariosBelgium: Agence Fédérale des Medicaments et des Produits de la Santé
• Study type: Interventional

Clinical Trial Summary

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study

• A male or female adult >= 40 years of age

• Written informed consent to be obtained from the subject prior to study entry

• No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• subject should not be pregnant or plan to become pregnant.

Exclusion Criteria:

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

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

• Pregnant or lactating female

• Female planning to become pregnant or planning to discontinue contraceptive precautions

• Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines

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

• Any confirmed or suspected immunosuppressive or immunodeficient condition

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Tetanus

Intervention

Biological:
• Boostrix™ (dTpa)
Intramuscular, 3 doses
• GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)
Intramuscular, single dose
• Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 2 doses
• Ditanrix™ Adult, TedivaxTM (Td)
Intramuscular, 3 doses

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Brugge
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Wilrijk
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Utrecht
Spain	GSK Investigational Site	Alzira
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Centelles
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Mollet del Vallès
Spain	GSK Investigational Site	Vic

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Netherlands,  Spain, 

References & Publications (3)

Theeten H, Rümke H, Hoppener FJ, Vilatimó R, Narejos S, Van Damme P, Hoet B. Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. — View Citation

Van Damme P et al. Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. Abstract presented at the 27th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Brussels, Belgium. 09-13 June 2009.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity with respect to components of the study vaccines		One month after the third dose (Month 7)	No
Secondary	Immunogenicity with respect to components of the study vaccines		One month after each dose (Months 1, 2 and 7)	No
Secondary	Occurrence of solicited local and general symptoms		Within 15 days (day 0 -14) after each vaccine dose.	No
Secondary	Occurrence of unsolicited symptoms		Within 31 days (day 0-30) after each vaccine dose.	No
Secondary	Occurrence of serious adverse events		Until 31 days (day 0-30) after the last vaccine dose.	No
Secondary	Occurrence of large local swelling reported		Within 15 days (day 0-14) after each vaccine dose	No
Secondary	Use of concomitant medication taken		Within 31 days (day 0-30) after each vaccine dose	No

External Links

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