This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This is a Phase 3b study. Each study group is further stratified into two sub-groups depending on the gestational age at birth of the subject: * Stratum I: very pre-term infants, born after a gestational period of 27-30 weeks (189-216 days) (20% of enrolment). * Stratum II: mild pre-term infants born after a gestational period of 31-36 weeks (217-258 days) (80% of enrolment). The study will be conducted in a double-blind manner with respect to the HRV vaccine and placebo. The study will not be blinded with respect to the type of concomitantly administered routine infant vaccination. In accordance with the local National Plan of Immunisation schedule in each of the respective participating countries, GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib), Infanrix Quinta™ (DTPa-IPV-Hib), Infanrix™+IPV+Hib (DTPa+IPV+Hib) and/or Engerix-B™ (HBV) will be co-administered (at a maximum interval of two days from each other) with each HRV vaccine or placebo dose. Hepatitis B and Bacille Calmette-Guérin vaccines (BCG) at birth are allowed if included in the local National Plan of Immunisation schedule in participating countries. At the discretion of the investigator the following vaccines may be administered during each subject's study participation: * Vaccine against Streptococcus pneumoniae (Prevenar®) in France and Spain (concomitantly with HRV vaccine/Placebo). * Vaccine against Neisseria meningitidis (Neis Vacc C®) is allowed if there is at least 14-days interval with respect to the administration of the HRV vaccine/Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,009
GSK Investigational Site
Bondy, France
GSK Investigational Site
Bordeaux, France
GSK Investigational Site
Caen, France
GSK Investigational Site
Clermont-Ferrand, France
GSK Investigational Site
Lille, France
GSK Investigational Site
Lyon, France
GSK Investigational Site
Marseille, France
GSK Investigational Site
Paris, France
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Dębica, Poland
...and 21 more locations
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
An 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: From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.
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 Rotarix vaccine/Placebo dose.
Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.
Solicited symptoms included Diarrhea (3 or more looser than normal stools/day), Fever (axillary temperature ≥ 37.5 degrees Celsius (°C)), Irritability, Loss of appetite, and Vomiting
Time frame: Within 15 days after each Rotarix vaccine/Placebo dose.
Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.
Gastroenteritis (GE): diarrhoea with or without vomiting. Rotavirus (RV) GE: A GE episode was a RV GE if a stool sample taken during or not later than 7 days after the episode was RV positive by Enzyme Linked Immunosorbent Assay.
Time frame: From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo
Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.
Number of subjects with anti-rotavirus IgA antibody concentration ≥ 20 Units/milliliter (U/mL).
Time frame: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
Serum Anti-Rotavirus IgA Antibody Concentration.
Anti-rotavirus IgA antibody concentrations are given as geometric mean concentrations (GMC) with 95% Confidence Intervals, calculated on all subjects.
Time frame: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo
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