Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.|
- Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. [ Time Frame: 2 months post-Dose 2 (at study Month 4) ] [ Designated as safety issue: No ]Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (<) 20 U/mL.
- Serum Anti-rotavirus IgA Antibody Concentrations. [ Time Frame: 2 months post-Dose 2 (at study Month 4) ] [ Designated as safety issue: No ]Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects.
- Number of Subjects Reporting Solicited General Symptoms. [ Time Frame: During the 8-day (Days 0-7) post-vaccination period ] [ Designated as safety issue: No ]Solicited general symptoms assessed were cough, diarrhoea, irritability, loss of appetite, temperature (any temperature was defined as a tympanic on rectal setting temperature ≥ 38.0 degrees Celsius) and vomiting.
- Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. [ Time Frame: From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) ] [ Designated as safety issue: No ]
RV was not identified in the one GE stool sample collected in the study. Two subjects reported GE episode between vaccination Dose 1 and before vaccination Dose 2. For one of them, GE stool sample was not collected and for the other subject no RV was identified in the GE stool sample.
GE symptoms were defined as diarrhoea with or without vomiting. A GE stool sample was collected as soon as possible after the illness began by the parent/guardian of the subject. Presence of RV antigen was detected by Enzyme-linked immunosorbent assay (ELISA).
- Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow-up period after vaccination ] [ Designated as safety issue: No ]An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
- Number of Subjects Reporting Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (from Dose 1 at Day 0 up to Month 4) ] [ Designated as safety issue: No ]SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
|Study Start Date:||November 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Rotarix Group
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
Biological: Rotarix TM
Oral, 2 doses