E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers: indicated for primary vaccination in infants for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. |
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E.1.1.1 | Medical condition in easily understood language |
Protection against diphtheria, tetanus, pertussis and poliomyelitis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036897 |
E.1.2 | Term | Prophylactic vaccination |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10043413 |
E.1.2 | Term | Therapeutic procedures and supportive care NEC |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021430 |
E.1.2 | Term | Immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10021431 |
E.1.2 | Term | Immunisations |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur’s DTaP-IPV combined vaccine versus commercially available Biken’s DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur’s IPV (IMOVAX POLIO™) monovalent vaccines, one month after the three-dose primary vaccination. |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity:
To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur’s DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France).
To assess and describe the immunogenicity of the study vaccines in both groups.
Safety:
To assess and describe the safety of the study vaccines after each dose. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 56 to 70 days inclusive on the day of inclusion
2) Born at full term pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures |
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E.4 | Principal exclusion criteria |
1) Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination.
2) Planned participation in another clinical trial during the present trial period.
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
4) Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
5) Chronic illness at a stage that could interfere with trial conduct or completion.
6) Blood or blood–derived products received in the past or planned administration during the trial (including immunoglobulins).
7) Any vaccination in the 3 weeks preceding the first trial vaccination.
8) History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically).
9) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine.
10) Thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination
11) History of major neurological diseases or seizures.
12) Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) on the day of inclusion.
13) Known family history of congenital or genetic immuno-deficiency. |
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E.5 End points |
E.5.1 | Primary end point(s) |
One month after the third dose of study vaccines (at V04):
Seroprotection:
• Anti-Tetanus antibody titers ≥ 0.1 IU/mL (ELISA)
• Anti-Diphtheria antibody titers ≥ 0.01 IU/mL (Seroneutralization)
• Anti-Polio 1, 2 and 3 antibody titers ≥ 8 (1/dil)
Seroconversion/Vaccine Response :
• Anti-PT and anti-FHA antibody titers (EU/mL) ≥ 4-fold increase |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 blood samples of 5 mL: immediately before dose 1 and 1 month after dose 3. |
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E.5.2 | Secondary end point(s) |
One month after the third dose of study vaccines (at V04):
- Seroprotection rates: anti-Diphtheria antibody titer ≥ 0.1 IU/mL (Seroneutralization), anti-Tetanus antibody titers ≥ 0.01 IU/mL (ELISA),
- Seroconversion/ Vaccine Response rates: anti-PT and anti-FHA antibody titers (EU/mL) ≥ 2-fold increase
- Percentage of subjects with anti-PT and anti-FHA antibody titers ≥ 5 EU/mL, ≥ 10 EU/mL and ≥ 25 EU/mL
- GMTs for all antibodies and GMT ratios: for anti-FHA (EU/mL) and anti-PT (EU/mL) antibody titers. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 blood samples of 5 mL: immediately before dose 1 and 1 month after dose 3. |
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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 | No |
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 |
Non-inferiority
Immunogenicity |
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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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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?
| 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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |