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®

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: GSK Biologicals' IPV vaccine; Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine; Biological: Revaxis®; Biological: Boostrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01277705

711866/003

Details and patient eligibility

About

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®

Enrollment: 806 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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806 participants in 3 patient groups

Group A

Experimental group

Treatment:

Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine

Group B

Experimental group

Treatment:

Biological: GSK Biologicals' IPV vaccine

Biological: Boostrix™

Group C

Active Comparator group

Treatment:

Biological: Revaxis®