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

Condition(s) targeted: Rotavirus Gastroenteritis

Intervention: Rotarix TM (Biological)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: +877-379-3718

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: 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: Immunogenicity to study vaccine antigen

Secondary outcome:

Immunogenicity to study vaccine antigen

Occurrence of each type of solicited symptom

Occurrence of unsolicited adverse event

Occurrence of serious adverse events

Presence of rotavirus in gastroenteritis stool samples.

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.

US GSK Clinical Trials Call Center, Phone: +877-379-3718

GSK Investigational Site, No.7 Chung San South Road, Taipei 100, Taiwan

Starting date: October 2010
Last updated: September 9, 2010