E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diphtheria Tetanus Pertussis Poliomyelitis
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E.1.1.1 | Medical condition in easily understood language |
Diphtheria Tetanus Pertussis Poliomyelitis
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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 describe the immunogenicity profile of ADACEL Polio (TdcP-IPV vaccine) one month after administration. |
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E.2.2 | Secondary objectives of the trial |
1) To describe the safety profile of ADACEL Polio (TdcP-IPV vaccine) when given as a fifth dose |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 6 to 8 years on the day of inclusion 2) Informed consent form signed by the parent(s) or another legally acceptable representative 3) Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures 4) Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines 5) Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire. |
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E.4 | Principal exclusion criteria |
1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination 2) Planned participation in another clinical trial during the present trial period 3) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy 4) Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events. 5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator 6) Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy 7) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response 8) Receipt of any vaccine in the 4 weeks preceding the trial vaccination 9) Planned receipt of any vaccine in the 4 weeks following the trial vaccination 10) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity 11) History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically) 12) Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine 13) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination 14) Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial 15) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw 16) Febrile illness (temperature ≥ 37.5°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) Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine 2) Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine 3) Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination 4) Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) Day 28 post-vaccination 2) Day 28 post-vaccination 3) Day 28 post-vaccination 4) Day 0 (pre-vaccination) and Day 28 post-vaccination |
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E.5.2 | Secondary end point(s) |
1) Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0 up to Day 7 post-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?
| 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 days | 28 |