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 |
1) To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV).
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E.2.2 | Secondary objectives of the trial |
1) To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination.
2) To describe the safety after each dose of IPV.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
2) Informed consent form signed by the parent(s) or other legal representative
3) Able to attend all scheduled visits and to comply with all trial procedures |
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E.4 | Principal exclusion criteria |
1) Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
2) Any serious disease whether acute or chronic
3) History of poliomyelitis infection
4) History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
5) History of anaphylaxis or allergy to any of the study vaccine components
6) Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
7) Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
8) Participation in another clinical trial preceding the trial inclusion
9) Planned participation in another clinical trial during the present trial period
10) Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
11) Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
12) Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
13) Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
14) Subject ineligible according to the investigator's clinical judgment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month post-vaccination 3 |
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E.5.2 | Secondary end point(s) |
1) Immunogenicity (in terms of seroprotection and geometric mean titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination
2) Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV
3) Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and geometric mean titers) of inactivated polio vaccine (IPV) after the booster vaccination |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Day 0 and 1 month post-vaccination
2) Day 0 up to 12 months post-vaccination
3) 1 month post-booster vaccination |
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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) | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
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 days | 20 |