Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

Official Title
-----------------
Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Biological: Rotarix
* Biological: Placebo


Participation Criteria
=================
Eligibility 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 and 12 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study. 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. Child is unlikely to remain in the study area for the duration of the study. Previous confirmed occurrence of rotavirus gastroenteritis. Gastroenteritis within 7 days preceding the study vaccine administration. Household contact with an immunosuppressed individual or pregnant woman. Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s). Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 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. Major congenital defects or serious chronic illness. Acute disease at time of enrollment. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group HRV Lot A<br> | Biological: Rotarix<br>* Two oral doses.<br>|
| Experimental: Group HRV Lot B<br> | Biological: Rotarix<br>* Two oral doses.<br>|
| Experimental: Group HRV Lot C<br> | Biological: Rotarix<br>* Two oral doses.<br>|
| Active Comparator: Group Placebo<br> | Biological: Placebo<br>* Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs). |  | Two months after Dose 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects. |  | Two months after Dose 1. | 
| Seroconversion rates to anti-rotavirus IgA antibody |  | Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects). | 
| Vaccine take rates in a subset of subjects. |  | Two months after each dose | 
| Presence of rotavirus in stool samples in a subset of subjects |  | On the day of each vaccination and on planned days following each vaccination. | 
| For each type of solicited symptom, occurrence of the symptom |  | During the 8-day follow-up period after each vaccine dose | 
| Occurrence of unsolicited symptoms |  | During the 31-day follow-up period after each vaccine dose. | 
| Occurrence of serious adverse events |  | Throughout the study period. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroenteritis