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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM); Biological: Boostrix™ (dTpa); Biological: Ditanrix™ Adult, TedivaxTM (Td)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294605

263855/034

Details and patient eligibility

About

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.

Enrollment: 460 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 3 patient groups

Group A

Experimental group

Treatment:

Biological: Boostrix™ (dTpa)

Group B

Experimental group

Treatment:

Biological: Ditanrix™ Adult, TedivaxTM (Td)

Biological: Ditanrix™ Adult, TedivaxTM (Td)

Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)

Group C

Active Comparator group

Treatment:

Biological: Ditanrix™ Adult, TedivaxTM (Td)

Biological: Ditanrix™ Adult, TedivaxTM (Td)