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®
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277705
First received: January 13, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
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®
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Diphtheria Pertussis Tetanus |
Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine Biological: Boostrix™ Biological: GSK Biologicals' IPV vaccine Biological: Revaxis® |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Boostrix
Inactivated Poliomyelitis Vaccine
Adacel
Poliovirus Vaccines
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after vaccination (Month 1) ] [ Designated as safety issue: No ]
- Immunogenicity with respect to some component of the study vaccines [ Time Frame: At Day 10 after vaccination ] [ Designated as safety issue: No ]
- Occurrence of solicited local and general symptoms [ Time Frame: within 15 (Day 0-14) days after vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited symptoms [ Time Frame: within 30 days (Day 0-29) after vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [ Time Frame: Throughout the entire study (from Day 0 to Day 30) ] [ Designated as safety issue: No ]
| Enrollment: | 806 |
| Study Start Date: | January 2002 |
| Study Completion Date: | April 2002 |
| Primary Completion Date: | April 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Biological: GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine
Intramuscular, single
|
| Experimental: Group B |
Biological: Boostrix™
Intramuscular, single dose
Biological: GSK Biologicals' IPV vaccine
Intramuscular, single dose
|
| Active Comparator: Group C |
Biological: Revaxis®
Intramuscular, single dose
|
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
Publications:
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT01277705 History of Changes |
| Other Study ID Numbers: | 711866/003 |
| Study First Received: | January 13, 2011 |
| Last Updated: | January 13, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut |
Keywords provided by GlaxoSmithKline:
|
Booster vaccination |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Myelitis |
Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Hypocalcemia Calcium Metabolism Disorders |
ClinicalTrials.gov processed this record on May 22, 2013