E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV)) |
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E.1.1.1 | Medical condition in easily understood language |
Rotavirus gastroenteritis |
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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 GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of grade “3” solicited adverse events (AEs). |
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E.2.2 | Secondary objectives of the trial |
•To assess the reactogenicity of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of solicited AEs.
•To assess the safety of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of unsolicited AEs and serious adverse events (SAEs).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subjects who the investigator believed that their parents/ Legally Acceptable Representative(s) (LARs could) can and wouldwill comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
•A male or female infant of Chinese origin between, and including, 6 and 16 weeks (42–112 days) of age at the time of the first vaccination.
•Written informed consent was obtained from the parents/LARs of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Born after a gestation period of 36 to 42 weeks inclusive.
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E.4 | Principal exclusion criteria |
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first 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 (for corticosteroids, this meant prednisone, > or equivalent to 0.5 mg/kg/day. Inhaled and topical steroids were allowed).
•Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the HRV vaccine or placebo except for the routine childhood vaccinations (i.e. DTP and OPV).
•Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel’s diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. The vaccine could be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.1°C as defined by the Chinese authorities). Temperature greater than or equal to this cut-off warranted deferral of the vaccination pending recovery of the subject.
•History of confirmed RV GE.
•GE within 7 days preceding the study vaccine or placebo administration (warranted deferral of the vaccination).
•Previous vaccination with RV vaccine or planned to use during the study period.
•Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
•Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of solicited AEs (grade “3”) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within the 8-day (Day 0 to Day 7) follow-up period after each dose of liquid HRV vaccine or placebo.
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E.5.2 | Secondary end point(s) |
Occurrence of each solicited AE.
Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
Occurrence of serious adverse events (SAEs), according to the MedDRA classification.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Solicited AEs: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of liquid HRV vaccine or placebo.
Unsolicited AEs: Within the 31-day (Day 0 to Day 30) follow-up after any dose of liquid HRV vaccine or placebo.
SAEs: Throughout the study period after Dose 1 of the liquid HRV vaccine or placebo (Approximately 2 months) |
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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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Marketing authorisation for the liquid HRV vaccine in China |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 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?
| 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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |