Comparison of the immunogenicity and safety of a combined adsorbed low dose diphtheria, tetanus and inactivated poliomyelitis vaccine (REVAXIS®) with a combined diphtheria, tetanus and inactivated poliomyelitis vaccine (DT Polio®) when given as a booster dose at 6 years of age - REVAXIS® versus DT Polio® as a second booster in 6 year-old childre
- Conditions
- ot applicable - Healthy volunteers - 6 year-old child
- Registration Number
- EUCTR2005-001446-16-FR
- Lead Sponsor
- Sanofi Pasteur MSD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 760
Subjects will be included in the study if they meet all of the following inclusion criteria:
1.Healthy child without chronic severe disease of either gender and affiliated to a health social secrurity system,
2.6 year-old child (from 1st day to last day of 7th year),
3.Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 14 - 20 months of life,
4.Consent form signed by both parents, or by the legal representative, properly informed about the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects will not be included in the study if they meet any of the non-inclusion criteria:
1.Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine given alone or in combination,
2.Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
3.Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
4.Child who present with immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity or who had received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term ( = 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [= 20mg/day prednisone equivalent] ),
5.Child who had received within the previous 3 months (150 days) or who will receive during the course of the study, any immunoglobulin or blood products,
6.Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
7.Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8.Child who had presented severe hypersensitivity following an earlier immunisation against diphtheria and/or tetanus,
9.Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
10.Any medical condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives,
11.Child who had participated in another clinical study in the previous 30 days or who will participate in another clinical study during the whole study period,
12.Acute severe febrile illness and/or rectal equivalent temperature = 38.0°C at the time of vaccination. Defer vaccination until 72 hours after fever resolution
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method