E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Active immunisation of infants from the age of 6 weeks for prevention of gastroenteritis due to rotavirus infection). |
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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 occurrence of at least one grade “2” or grade “3” fever, vomiting or diarrhoea within the 8-day (Day 0 - Day 7) follow-up period after any Rotarix vaccination. |
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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 (Day 0 – Day 7) follow-up period after each dose of the vaccination.
• To assess the safety of Rotarix in terms of occurrence of unsolicited AEs within a 31-day (Day 0 – Day 30) follow-up period after any vaccination, according to Medical Dictionary for Regulatory Activities (MedDRA) classification.
• To assess the safety of Rotarix in terms of serious adverse events (SAEs) throughout the surveillance period after the first dose administered in the PMS.
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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 should be enrolled in this PMS.
• A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second 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 exacerbated by any component of the vaccine.
• Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Acute disease at the time of enrolment.
• Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception (IS).
• Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine.
•Gastroenteritis within 7 days preceding vaccination. |
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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 (Day 0-Day 7) follow-up period after any Rotarix vaccination. |
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E.5.2 | Secondary end point(s) |
1) For each type of solicited symptom, occurrence of the symptom.
2) Occurrence of unsolicited symptoms according to MedDRA classification.
3) Occurrence of Serious adverse events (SAEs). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For endpoint 1: Within the 8-day (Day 0 - Day 7) follow-up period after each dose of the vaccination.
For endpoint 2: During the 31-day (Day 0 - Day 30) follow-up period after any vaccination.
For endpoint 3: Throughout the surveillance period following the first dose administered in 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 | No |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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?
| 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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |