E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
DTaP-IPV-HB-PRP-T Combined Vaccine in Human Immunodeficiency Virus Exposed Infected and Uninfected Infants |
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E.1.1.1 | Medical condition in easily understood language |
Active immunization against diphtheriae, tetanus, pertussis, hepatitis B, poliomyelitis & invasive infections caused by Haemophilus influenzae type b, for infant with HIV Infection |
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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 | 20.0 |
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 |
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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 evaluate the immunogenicity of the study vaccine 1 month after the 3-dose primary series in HIV-exposed infected and in HIV-exposed uninfected infants - To describe the persistence of all antibodies before receipt of the booster vaccination in HIV-exposed infected and in HIV-exposed uninfected infants - To evaluate the immunogenicity of the study vaccine 1 month after the booster dose in HIV-exposed infected and in HIV-exposed uninfected infants
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E.2.2 | Secondary objectives of the trial |
- To describe the safety profile after each and all doses of the study vaccine administered as a 3-dose infant primary series in HIV-exposed infected and in HIV-exposed uninfected infants - To describe the safety profile of the study vaccine administered as a booster in HIV-exposed infected and in HIV-exposed uninfected infants
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Screening Criteria): - At least 18 years of age at the time of the subject's PCR blood sample draw - Self-reported or maternity-reported HIV infection in the mother
Inclusion Criteria: - Born to an adult mother and aged 35 to 56 days (between 5 and 8 weeks of age) on the day of inclusion - Group A subjects must be HIV infected, as documented through the results of a PCR test, and following an anti-retroviral therapy according to the national recommendations; and Group B subjects must be HIV exposed uninfected infants, as documented through the results of a PCR test. - Born with a birth weight ≥ 2.0 kg - Informed consent form signed by the parent(s)/legal guardian(s) and by one independent witness if the parent(s)/legal guardian(s) is illiterate - Subject and parent(s)/legal guardian(s) are able to attend all scheduled visits and to comply with all trial procedures. |
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E.4 | Principal exclusion criteria |
- Participation in another clinical trial of an investigational product in the 4 weeks preceding the trial inclusion (receipt of study vaccine) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure - Group A subjects diagnosed with a chronic condition, except HIV infection, or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder; and Group B subjects diagnosed with chronic illness or any experience of blood or blood-derived products received or experience of thrombocytopenia or bleeding disorder. - Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (oral polio vaccine [OPV] given at birth does not constitute an exclusion criteria), hepatitis B (a birth dose of Hep B vaccine does not constitute an exclusion criteria) diseases or Hib infection with the trial vaccine or another vaccine. Previous vaccination with Bacillus Calmette-Guerin (BCG) is not considered an exclusion criterion - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically) - History of seizures or history of uncontrolled neurologic disorder or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilized and the benefit clearly outweighs the risk - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances - Febrile (axillary temperature ≥ 38°C) or acute illness on the day of inclusion (temporary contraindication). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of participants with anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations ≥ Lower Limit of Quantitation (LLOQ) and ≥ 4 x LLOQ at baseline.
2. Number of participants with vaccine response for pertussis toxoid and Filamentous Hemagglutinin antigens post vaccination with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine. Vaccine response defined as post-third dose anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibody concentrations ≥ 4 x LLOQ if pre-vaccination concentration is < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ
3. Number of participants with ≥ 4-fold increase in anti-Pertussis toxoid and anti-filamentous Hemagglutinin antibody concentrations (EU/mL) from pre-dose 1 to one month post-dose 3 vaccination with Sanofi Pasteur's DTaP-IPV-HB-PRP-T combined vaccine.
4. Number of participants with anti-Diphtheria antibody concentrations ≥ 0.01 and ≥ 0.1 IU/mL International Units (IU)/mL post-third dose vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Day 0 (pre-vaccination) 2. Day 21 post-dose 3 3. Day 21 post-dose 3 4. Day 21 post-dose 3 |
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E.5.2 | Secondary end point(s) |
Number of subjects reporting solicited injection-site reactions, solicited systemic reactions, unsolicited systemic reactions and serious adverse events occurring throughout the trial. Solicited injection-site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and Irritability; and unsolicited adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0 up to 14 months 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 | No |
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 | No |
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.8.3 |
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 years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |