Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01287949
First received: January 31, 2011
Last updated: June 6, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary objective:
- To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects
Secondary objectives:
- If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
- To describe the immune responses to REPEVAX in these subjects
- To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Poliomyelitis Pertussis |
Biological: Diphtheria, tetanus, polio and pertussis vaccination |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older Without a Previous Diphtheria- and Tetanus-containing Booster Within the Last 20 Years |
Resource links provided by NLM:
Further study details as provided by Sanofi Pasteur MSD:
Primary Outcome Measures:
- Diphtheria seroprotection rate [ Time Frame: 28 to 35 days afeter each vaccine administration ] [ Designated as safety issue: No ]
- Tetanus seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ] [ Designated as safety issue: No ]
- Polio seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ] [ Designated as safety issue: No ]
- Pertussis response rate [ Time Frame: 28 to 35 days after REPEVAX administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Solicited injection-site reactions, solicited systemic reactions [ Time Frame: From day 0 to day 7 following REPEVAX and REVAXIS vaccination ] [ Designated as safety issue: Yes ]
- Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: From day 0 to day 28 following REPEVAX and REVAXIS vaccination ] [ Designated as safety issue: Yes ]
- Number and proportion of Serious adverse events [ Time Frame: From the first vaccination to the last visit of the subject ] [ Designated as safety issue: Yes ]
| Enrollment: | 342 |
| Study Start Date: | January 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: REPEVAX followed by REVAXIS administration |
Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adults aged ≥40 years
- No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years
Exclusion Criteria:
- Medically diagnosed pertussis disease within the last 10 years
- Receipt of medication / vaccine that may interfere with study assessments
- Febrile illness or moderate or severe acute illness/infection
- Know pregnancy
- History of hypersensitivity or anaphylactic or other allergic reactions to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
- History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
- History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders
- Known or suspected immune dysfunction
- Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
- Chronic disease or intercurrent illness that might interfere with study assessments
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287949
Locations
| France | |
| Sanofi Pasteur MSD investigational site | |
| Clermont-Ferrand, France | |
| Sanofi Pasteur MSD investigational site | |
| Lille, France | |
| Sanofi Pasteur MSD investigational site | |
| Montpellier, France | |
| Sanofi Pasteur MSD investigational site | |
| Paris, France | |
| Sanofi Pasteur MSD investigational site | |
| Poitiers, France | |
| Sanofi Pasteur MSD investigational site | |
| Saint-Etienne, France | |
| Germany | |
| Sanofi Pasteur MSD investigational site | |
| Balve, Germany | |
| Sanofi Pasteur MSD investigational site | |
| Berlin, Germany | |
| Sanofi Pasteur MSD investigational site | |
| Dülmen, Germany | |
| Sanofi Pasteur MSD investigational site | |
| Nürnberg, Germany | |
| Sanofi Pasteur MSD investigational site | |
| Offenbach, Germany | |
| Sanofi Pasteur MSD investigational site | |
| Rodgau, Germany | |
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
| Study Director: | Marie WEHRLEN-GRANDJEAN, MD | Sanofi Pasteur MSD |
More Information
No publications provided
| Responsible Party: | Sanofi Pasteur MSD |
| ClinicalTrials.gov Identifier: | NCT01287949 History of Changes |
| Other Study ID Numbers: | RPV04C |
| Study First Received: | January 31, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut |
Keywords provided by Sanofi Pasteur MSD:
|
Diphtheria Tetanus Poliomyelitis Pertussis (acellular) Biological/vaccine |
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