E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rotavirus gateroenteritis |
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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 demonstrate at least 40% increase in seroconversion rate, in the HRV vaccine group at Visit 3 (i.e. one month post-Dose 2) as compared to Placebo group.
Criteria: the primary objective was met if the lower limit (LL) of the two-sided asymptotic standardised 95% Confidence interval (CI) for treatment differ-ence (HRV vaccine minus placebo) was greater than or equal to 40%
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E.2.2 | Secondary objectives of the trial |
-To assess the immunogenicity of the HRV vaccine in terms of serum anti RV Immunoglobulin A (IgA) antibody concentrations at Visit 3 (i.e. one month post-Dose 2).
-To assess the reactogenicity of HRV vaccine in terms of occurrence of solicited adverse events (AEs) within a 8-day (Day 0-Day 7) follow-up period after each vaccine dose.
-To assess the safety of HRV vaccine in terms of occur-rence of unsolicited AEs within a 31-day (Day 0-Day 30) follow-up period after any vaccine dose.
-To assess the safety of HRV vaccine in terms of SAEs throughout the study period.
-To assess the presence of RV in GE stools collected up to Visit 3.
-To evaluate non-inferiority in terms of seroconversion rate from this study as compared to that of the seroconversion rate observed in the NCT00140673 study.
Criteria: Non-inferiority was reached if the LL of the two-sided 95% CI for the difference in seroconversion rate between this study and (minus) the NCT00140673 study was above -20%.
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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 the study.
-A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
-Written informed consent obtained from the parents or guardians of the subject.
-Healthy subjects as established by medical history and clinical examination before entering into the study.
-Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
-Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
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E.4 | Principal exclusion criteria |
-Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
-Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
-Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
-Acute disease at the time of enrolment.
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
-Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
-Previous confirmed occurrence of RV GE.
-Previous vaccination with rotavirus vaccine or planned use during the study period.
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E.5 End points |
E.5.1 | Primary end point(s) |
Anti-RV IgA seroconversion |
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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) |
-Serum anti-RV IgA antibody concentration
-Anti-RV IgA seroconversion rate observed in this study as com-pared to the seroconversion rate in the NCT00140673 study.
-Occurrence of each type of solicited symptoms
-Occurrence of unsolicited adverse event (AE)
-Occurrence of serious adverse events (SAEs)
-Presence of rotavirus (RV) in Gastroenteritis (GE) stool samples
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Anti-RV IgA antibody concentration and seroconversion: At Visit 3 (Month 2-3), Solicited symptom: During the 8-day (Day 0 – Day 7) follow-up period after each vaccine dose, Unsolicited adverse event: During the 31-day (Day 0 – Day 30) follow-up period after each vaccine dose, SAEs: Throughout the study period (3 months), RVGE in stool samples: From Visit 1 (Day 0) up to Visit 3 (Month2-3) |
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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 | 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?
| 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 | 0 |