Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly
- Conditions
- PoliomyelitisTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005183-42-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 236
Inclusion Criteria to be checked at the screening visit (SC):
- Aged 0 to 7 days on the day of screening
- Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
- Informed consent form signed by the parent(s) or other legally acceptable representative
- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- Inclusion Criteria to be checked at the randomization visit (V01):
- Aged 42 to 50 days on the day of inclusion
- Subjects and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 236
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
Exclusion Criteria to be checked at the screening visit (SC):
- Planned participation in another clinical trial during the present trial period
- Illness that could interfere with trial conduct or completion, in the opinion of the investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- Thrombocytopenia or bleeding disorder contraindicating IM injection
- Exclusion Criteria to be checked at the randomization visit (V01):
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except BCG, DTP-Hib or Hepatitis B vaccines, which can not be given within 10 days before or after any study vaccination)
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity
- History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against the poliomyelitis disease with either the trial vaccine or another vaccine
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) injection
- Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To demonstrate the non-inferiority of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates<br>(polio types 1, 2 and 3) one month after the three-dose primary vaccination.;Secondary Objective: Immunogenicity:<br> - To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination.<br><br>Safety:<br> - To describe in each group the safety after each dose of the study vaccines.;Primary end point(s): 1) The non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1 2 and 3) one month after the three-dose primary vaccination;Timepoint(s) of evaluation of this end point: 1 month Post-vaccination
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Immunogenicity: <br>1) To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination <br><br>Safety: <br>1) To describe in each group the safety after each dose of the study vaccines;Timepoint(s) of evaluation of this end point: 1 month post-vaccination