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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-11

Study Completion Date

2011-04-18

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.

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Detailed Description

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Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rotarix Group

subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.

Group Type EXPERIMENTAL

Rotarix TM

Intervention Type BIOLOGICAL

Oral, 2 doses

Interventions

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Rotarix TM

Oral, 2 doses

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Lu CY, Chang LY, Shao PL, Suryakiran PV, Han HH, Huang LM. Immunogenicity, reactogenicity, and safety of a human rotavirus vaccine, Rotarix, in Taiwanese infants who received a dose of hepatitis B immunoglobulin after birth. J Formos Med Assoc. 2013 Sep;112(9):574-7. doi: 10.1016/j.jfma.2012.11.016. Epub 2013 Jan 3.

Reference Type DERIVED

PMID: 24079716 (View on PubMed)

Study Documents

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