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

Phase 4

Completed

• Conditions: Acellular Pertussis; Tetanus; Diphtheria
• Interventions: Biological: Boostrix™ (dTpa); Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM); Biological: Ditanrix™ Adult, TedivaxTM (Td)

• Registration Number: NCT01294605
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Ditanrix™ Adult, TedivaxTM (Td)	-
Group C	Ditanrix™ Adult, TedivaxTM (Td)	-
Group A	Boostrix™ (dTpa)	-
Group B	GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity with respect to components of the study vaccines	One month after the third dose (Month 7)

Secondary Outcome Measures

Name	Time	Method
Occurrence of serious adverse events	Until 31 days (day 0-30) after the last vaccine dose.
Occurrence of large local swelling reported	Within 15 days (day 0-14) after each vaccine dose
Use of concomitant medication taken	Within 31 days (day 0-30) after each vaccine dose
Occurrence of solicited local and general symptoms	Within 15 days (day 0 -14) after each vaccine dose.
Immunogenicity with respect to components of the study vaccines	One month after each dose (Months 1, 2 and 7)
Occurrence of unsolicited symptoms	Within 31 days (day 0-30) after each vaccine dose.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Vic, Spain