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

NCT01198769 | Completed Phase 4 Results

• 1 other identifier: 114351
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infections, Rotavirus

Keywords

Human rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Serum Anti-rotavirus IgA Antibody Concentrations.

  2 months post-Dose 2 (at study Month 4)

• Number of Subjects Reporting Solicited General Symptoms.

  During the 8-day (Days 0-7) post-vaccination period

• Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.

  From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2)

• Number of Subjects Reporting Unsolicited Adverse Events (AEs).

  Within the 31-day (Days 0-30) follow-up period after vaccination

• Number of Subjects Reporting Serious Adverse Events (SAEs).

  During the entire study period (from Dose 1 at Day 0 up to Month 4)

Study Arms (1)

Rotarix Group

EXPERIMENTAL

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

Biological: Rotarix TM

Interventions

Rotarix TM BIOLOGICAL

Oral, 2 doses

Rotarix Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24079716 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 10, 2010
• Study Start: November 11, 2010
• Primary Completion: April 18, 2011
• Study Completion: April 18, 2011
• Last Updated: August 20, 2018
• Results First Posted: April 17, 2012

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)