E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To demonstrate the non-inferiority of fractional doses of IPV administered intradermally versus full doses of IPV administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination. |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity: - To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination.
Safety: - To describe in each group the safety after each dose of the study vaccines. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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 |
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E.4 | Principal exclusion criteria |
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 |
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Immunogenicity: 1) To assess and describe in each group the immunogenicity of the study vaccines one month after the three-dose primary vaccination
Safety: 1) To describe in each group the safety after each dose of the study vaccines |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Inactivated Poliomyelitis Vaccine |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 5 |