Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rotavirus Gastroenteritis
Intervention: Rotarix TM (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: 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.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
Secondary outcome: Serum Anti-rotavirus IgA Antibody Concentrations.Number of Subjects Reporting Solicited General Symptoms. Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample. Number of Subjects Reporting Unsolicited Adverse Events (AEs). Number of Subjects Reporting Serious Adverse Events (SAEs).
Eligibility
Minimum age: 6 Weeks.
Maximum age: 12 Weeks.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
GSK Investigational Site, Taipei 100, Taiwan
Additional Information
Starting date: November 2010
Last updated: June 7, 2012
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