Rotavirus (RV) gastroenteritis
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with a live twin living in the same household who is also enrolled in this study. Subjects born after a gestation period of = 32 weeks. Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (stool collection, return for follow-up visits, etc.) were to be enrolled in the study. A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination. Written informed consent obtained from the parent or guardian of the subjects. Healthy subjects as established by medical history and clinical examination before entering into the study. Discharged from hospital neonatal care stay. Are the trial subjects under 18? yes Number of subjects for this age range: 200 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 first dose of study vaccine, or planned use during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 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 time of enrolment. (Acute disease was defined as the presence of moderate or severe illness with or without fever i.e. temperature > 37.5°C as measured by an axillary thermometer or > 38.0°C as measured by a rectal thermometer). Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Contact with an immunosuppressed individual. Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or was exposed to an investigational or a non-investigational product (pharmaceutical product or device). Chronic administration (defined as more than 14 days) of immunosuppressants since birth (topical steroids were allowed). Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). Documented HIV-positive subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the rate of transmission of the HRV vaccine strain to twin receiving placebo using RV detection by ELISA and vaccine strain identification using appropriate molecular technique.;Secondary Objective: -To identify potential genetic variation (full genome sequencing) of any HRV vaccine strain isolated from twin receiving placebo and from the twin receiving the HRV vaccine if applicable. In case of transmission, to determine the infectious viral load in the stool of the twin receiving placebo. -To determine the rate of seroconversion and GMCs to anti-RV IgA antibodies at Visit 3 in twins vaccinated with HRV vaccine and in twins receiving the placebo (seroconversion caused either by natural infection or by transmission). -To assess the occurrence of gastroenteritis (GE) until study end and RV GE until Visit 3. -To assess the safety of the study vaccine throughout the study period.;Primary end point(s): Presence of HRV vaccine strain in any stool sample from twin receiving placebo as detected by ELISA and identified by using appropriate molecular technique.;Timepoint(s) of evaluation of this end point: On the day of each dose of HRV vaccine or placebo or day before, then three times weekly for 6 consecutive weeks starting after each dose of HRV vaccine or placebo and on the day of Visit 3 (Week 13). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of HRV shedding per study group. Analysis by sequencing of genomic mutations in the HRV vaccine strain after transmission. Live viral vaccine load in the stool of the twin receiving placebo in case of transmission. Anti-rotavirus IgA antibody seroconversion and concentration in each group at Visit 3. Occurrence of GE Occurrence of AEs in all subjects Occurrence of SAEs in all subjects ;Timepoint(s) of evaluation of this end point: HRV shedding, sequencing of genetic mutations in HRV vaccine strain, viral vaccine load:On the day of each dose of HRV vaccine or placebo or day before, then three times weekly for 6 consecutive weeks starting after each dose of HRV vaccine or placebo and on the day of Visit 3 (Week 13). Anti-RV IgA antibody seroconversion: At Visit 3 (Week 13), Occurance of GE and RV GE: Day 0 till Visit 3 (Week 13) AEs: Within 31 days after each dose (Day 0-Day 30), SAEs: Day 0 to Week 17 | — |
Countries
Dominican Republic
Contacts
Public Contactclinical disclosure advisor
GlaxoSmithKline Biologicals
Outcome results
None listed