E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rotavirus Gastroenteritis |
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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 |
To assess the reactogenicity of Rotarix in terms of occur-rence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea within a 8-day follow-up period after each vaccine dose |
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E.2.2 | Secondary objectives of the trial |
To assess the reactogenicity of Rotarix in terms of occurrence of solicited adverse events (AEs) within a 8-day follow-up period after each vaccine dose.
To assess the safety of Rotarix in terms of occurrence of unsolicited AEs within a 31-day follow-up period after each vaccine dose.
To assess the safety of Rotarix in terms of serious adverse events (SAEs) throughout the study period after Dose 1 of Rotarix
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol .
A male or female at least 6 weeks of age at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the subject.
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E.4 | Principal exclusion criteria |
History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine.
Acute disease at the time of enrolment.
Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
Any contraindication as stated in the updated and approved Prescribing Information
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the 8-day follow-up period after each vaccine dose |
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E.5.2 | Secondary end point(s) |
For each type of solicited symptoms, occurrence of the symptom
Occurrence of unsolicited adverse event (AE)
Occurrence of Serious adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Solicited symptoms: During the 8-day follow-up period after each vaccine dose, Unsolicited AEs: During the 31-day follow-up period after each vaccine dose, SAEs:Throughout the study period (Month 3-4) |
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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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.3 |
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 | Yes |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 30 |