DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017