Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants

Study Overview
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Brief Summary
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The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.

Official Title
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Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV

Conditions
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Infections, Rotavirus, Rotavirus Vaccines

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


Participation Criteria
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Eligibility Criteria
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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 to 12 weeks of age at the time of the first dose of the vaccination. Written informed consent obtained from the parents or guardians of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive. Subjects for whom the vaccination history is available from vaccination diary cards or medical charts. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 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 the time of enrolment. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Gastroenteritis (GE) within 7 days preceding the study vaccine administration. Previous confirmed occurrence of RV GE. Previous vaccination with rotavirus vaccine or planned use during the study period.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotarix Group<br>Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule. | Biological: Rotarix ™<br>* Two oral doses<br>|
| Placebo Comparator: Placebo Group<br>Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule. | Biological: Placebo<br>* Two oral doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A | Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination. | One month after the second vaccine dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations | Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter). | One month after the second vaccine dose | 
| Number of Subjects Reporting Solicited Symptoms | Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting. | During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose. | 
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Unsolicited AE covers any AE 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. | During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose | 
| Number of Subjects Reporting Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. | Throughout the study period (2-3 months). | 
| Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s) |  | From Dose 1 up to 1 month after Dose 2. | 

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