The aim of this study is to explore horizontal transmission of the HRV (Human Rotavirus) vaccine strain within a family from the twin vaccinated with Rotarix to the twin receiving placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This is a Phase 3b study. Three doses of Infanrix® hexa will be administered to all subjects at the discretion of the investigator. One complimentary dose of Rotarix will be administered to all infants enrolled in this study (both study groups) who are aged less than 6 months at Visit 3 (Week 13) as a benefit to the placebo group for participation in the study. The study will be conducted in a double-blind manner with respect to Rotarix and placebo administered at Visit 1 and Visit 2. The parents/guardians of the subjects will know that within each pair of twins, one subject will receive the Rotarix vaccine and one subject will receive the placebo. The study will be open label with respect to administration of the Rotarix vaccine dose given at Visit 3 to all subjects in each group who are aged less than 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
GSK Investigational Site
Santo Domingo, Dominican Republic
Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo.
Number of subjects in the Placebo Group with rotavirus vaccine strain in at least one stool sample.
Time frame: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3.
Duration of Human Rotavirus (HRV) Shedding Per Study Group.
Duration of shedding in the Placebo Group= number of days between first and last stool sample positive (+) for rotavirus (RV) antigen and in the Rotarix Group= number of days between the day of vaccination and the date of last stool sample + for RV antigen.
Time frame: From Day 0 up to Week 13.
Number of Genetic Variation Differences Detected by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission.
Dissimilar amino acid substitutions in the HRV vaccine strain isolated from the twin receiving placebo, when compared to the genetic variation of HRV vaccine strain isolated from the Rotarix vaccine recipients, were counted as genetic variation differences.
Time frame: During the entire study period (up to Visit 4, Week 17).
Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission.
Number of subjects in the Placebo Group with live virus identified in at least one stool sample in case of transmission.
Time frame: During the entire study period (up to Visit 4, Week 17).
Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion.
Number of initially seronegative subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL), 1 month after the second dose.
Time frame: At Visit 3 (Week 13).
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Anti-rotavirus IgA Antibody Concentration.
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals.
Time frame: At Visit 3 (Week 13).
Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes.
GE episodes were defined as diarrhea (passage of three or more looser than normal stools within a day) with or without vomiting. RV GE episodes were defined as GE episodes for which the stool sample temporally closest to the onset day of the GE episode was positive for rotavirus by Enzyme Linked Immunosorbent Assay (ELISA).
Time frame: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Within 31 days after any doses.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: Up to Visit 4.