Rotavirus gateroenteritis
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 684 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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% ;Secondary Objective: -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%. ;Primary end point(s): Anti-RV IgA seroconversion ;Timepoint(s) of evaluation of this end point: At Visit 3 (Month 2-3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;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) | — |
Countries
Korea, Republic of
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed