E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants |
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E.1.1.1 | Medical condition in easily understood language |
Diarrhea and vomiting caused by the rotavirus germ in infants. |
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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 | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039232 |
E.1.2 | Term | Rotavirus gastroenteritis |
E.1.2 | System Organ Class | 100000004862 |
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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 |
(1) To evaluate the efficacy of a 3-dose regimen of V260 against rotavirus gastroenteritis of any severity caused by rotavirus serotypes G1, G2, G3, G4 and Gserotypes associated with serotype P1A (including G9) occurring at least 14 days following the third dose in healthy Japanese infants.
(2) To assess the safety of V260 with respect to all adverse experiences occurring within 14 days of any dosing in healthy Japanese infants.
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E.2.2 | Secondary objectives of the trial |
(1) To evaluate the efficacy of a 3-dose regimen of V260 against moderate to severe and severe rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and those associated with serotype P1A occurring at least 14 days following the third dose.
(2) To evaluate the efficacy of a 3-dose regimen of V260 against rotavirus gastroenteritis (moderate-severe, severe, and any severity, respectively) caused by any rotavirus serotype occurring at least 14 days following the third dose.
(3) To evaluate the cumulative efficacy following the first dose of a 3-dose regimen of V260 against rotavirus gastroenteritis (moderate-severe, severe, and any severity, respectively) caused by i) rotavirus serotypes G1, G2, G3, G4 and those associated with serotype P1A, and by ii) any rotavirus serotype.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy Japanese infants
2. Age 6 through exactly 12 weeks (≥42 days to ≤84 days from Date of Birth) upon the day of receipt of the first study vaccination (Day 1)
3. Parent/legal guardian understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
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E.4 | Principal exclusion criteria |
1. History of congenital abdominal disorders, intussusception, or abdominal surgery.
2. Known or suspected impairment of immunological function.
3. Known hypersensitivity to any component of the rotavirus vaccine, e.g., purified sucrose, sodium citrate, sodium phosphate, sodium hydroxide, surface active agent (Polysorbate 80), and inorganic salts, amino acids and vitamins contained in the culture media for tissue culture used into the manufacturing process of a vaccine.
4. Prior administration of any rotavirus vaccine.
5. Fever, with a rectal temperature ≥38.1ºC or axillary temperature ≥37.5ºC at the time of vaccination.
6. History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive.
7. Clinical evidence of active gastrointestinal illness. (Note that infants with gastroesophageal reflux disease [GERD] may participate in the study as long as the GERD is well controlled with or without medication.)
8. Receipt of intramuscular, oral, or intravenous corticosteroid treatment (Note that infants on inhaled steroids may participate in the study.)
9. Infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
10.Any prior receipt of a blood transfusion or blood products, including immunoglobulins.
11. Any infant who cannot be adequately followed for safety by telephone, e-mail or clinic visit.
12. Receipt of oral poliovirus vaccine (OPV) or Bacille Calmette-Guérin (BCG) within 27 days prior to the first dose of study vaccine/placebo
13. Subjects who are concurrently participating in or are anticipated to participate in other studies of investigational products at any time during the study period. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby-case basis for approval by the SPONSOR.
14. Any condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the incidence rate of rotavirus gastroenteritis caused by the rotavirus serotype G1, G2, G3, G4 and those associated with P1A occurring at least 14 days after third dose.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary efficacy endpoints include the incidence rate of rotavirus gastroenteritis by disease severity and caused by all rotavirus serotypes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The presence or absence of rotavirus gastroenteritis is evaluated from the first vaccination to the end of the study.
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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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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?
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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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 4 |