Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)

NCT00329745 | Completed Phase 3 Results

• 3 other identifiers: 107070107072107076
• Study Type: interventional
• Target: 8,687
• Locations: 1 country
• Sites: 4

Brief Summary

This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following schedules: at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or rota-030. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Infections, Rotavirus

Keywords

Rotavirus Gastroenteritis; Human rotavirus vaccine, efficacy, infants

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains

  Severe RV GE is an episode of severe GE in which rotavirus other than vaccine strain was identified in a GE stool sample. Note that this outcome measure is secondary in the study protocol. We have reported it here as primary outcome measure, since none of the primary outcome measures in the study protocol pertain to the time point (Year 3 follow-up) presented in this summary.

  From Year 2 up to Year 3

Secondary Outcomes (1)

• Number of Subjects Reporting Serious Adverse Events (SAEs)

  From the end of the primary study up to Year 3

Study Arms (2)

Rotarix Group

EXPERIMENTAL

During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.

Biological: Rotarix™

Placebo Group

PLACEBO COMPARATOR

During the primary study (NCT00197210) subjects received two oral doses of placebo.

Biological: Placebo

Interventions

Rotarix™ BIOLOGICAL

Oral administration, 2 doses

Rotarix Group

Placebo BIOLOGICAL

Oral administration, 2 doses

Placebo Group

Eligibility Criteria

• Age: 2 Years - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 6 and 12 weeks of age in Hong Kong and Taiwan or 11 to 17 weeks of age in Singapore at the time of the first vaccination according to the country recommendations for the routine vaccination schedules.
• Written informed consent obtained from the parent or guardian of the subject, prior any study procedure.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine or placebo, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
• Child is unlikely to remain in the study area for the duration of the study
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins is allowed.
• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
• First or second degree of consanguinity of parents.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Singapore, 228510, Singapore

Location

GSK Investigational Site

Singapore, 229899, Singapore

Location

GSK Investigational Site

Singapore, 308433, Singapore

Location

Related Links

• Reference to the Primary Study NCT number

MeSH Terms

Conditions

Rotavirus Infections

Interventions

RIX4414 vaccine

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 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 9, 2016
• Results First Posted: October 14, 2009

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

SG (4)