Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Biological: Rotarix TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. 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(s)/Legally Acceptable Representative(s) of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Infants who have received a previous dose of hepatitis B immunoglobulin after birth. Exclusion Criteria: Child in care. Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. 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. Previous vaccination against rotavirus. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. Family history of congenital or hereditary immunodeficiency. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. Acute disease and/or fever at the time of enrolment. Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period. Gastroenteritis within 7 days preceding the study vaccine administration. Previous confirmed occurrence of Rotavirus gastroenteritis.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotarix Group<br>subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age. | Biological: Rotarix TM<br>* Oral, 2 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody. | 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. | 2 months post-Dose 2 (at study Month 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Anti-rotavirus IgA Antibody Concentrations. | Concentrations were expressed as geometric mean antibody concentration in units per millilitre (U/mL), calculated on all subjects. | 2 months post-Dose 2 (at study Month 4) | 
| Number of Subjects Reporting Solicited General Symptoms. | 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. | During the 8-day (Days 0-7) post-vaccination period | 
| Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. | 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). | From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2) | 
| Number of Subjects Reporting Unsolicited Adverse Events (AEs). | 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. | Within the 31-day (Days 0-30) follow-up period after vaccination | 
| Number of Subjects Reporting Serious Adverse Events (SAEs). | 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. | During the entire study period (from Dose 1 at Day 0 up to Month 4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human rotavirus vaccine