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 in terms of seroprotection rates (polio types 1, 2 and 3) of IMOVAX Polio™ versus commercially available OPV one month after the 3-dose primary vaccination. |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity: - To assess and describe the immunogenicity of the study vaccines one month after the third dose of the primary vaccination in both groups. - To assess and describe the immunogenicity of polio types 1, 2, 3 in terms of antibody persistence approximately 14-16 months after the third dose of the primary vaccination in both groups. - To assess and describe the immunogenicity of the study vaccine after the IPV booster dose in Group A.
Safety: - To describe 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 |
- Aged 2 months (60-70 days) on the day of inclusion into the study - Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more - Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation - Able to attend all planned clinic appointment and obey and follow all study instructions |
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E.4 | Principal exclusion criteria |
- Taking part in another clinical trial during the 4 weeks before the first trial vaccination - Have plans to take part in another clinical trial d during this trial period - Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment - Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s) - Prolonged or long time illness that could interfere with study or full participation - Received blood or blood-derived products since birth - Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B) - Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP) - Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine - History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test) - Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV) - Bleeding disorder or a low platelet which do not allow vaccination into the muscle - Had seizures in the past - Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Seroprotection rates defined as anti-Polio 1, 2, and 3 antibody titers ≥ 8 (1/dil)1 month after the third dose of study vaccines (V04). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month post-vaccination 3 (V04) |
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E.5.2 | Secondary end point(s) |
1) Individual anti-Polio 1, 2 and 3 antibody titers 2) Individual antibody titers ratio, defined post-primary vaccination/pre-primary vaccination and post-booster dose/pre-booster dose 3) Anti-Polio 1, 2 and 3 titers ≥ 8 (1/dil) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 14-16 months after the 3-dose primary vaccination in both groups (at V05) and 1 month after the third dose in both groups (at V04) 2) 1 month after the third dose in both groups (at V04) 3) 14-16 months after the 3-dose primary vaccination in both groups (at V05) and 1 month after the IPV booster dose in the Group A (at V06): |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 |
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell), Live (OPV) |
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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 | 19 |