A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

NCT00432380 | Completed Phase 2 Results

• 2 other identifiers: 1092162015-001544-11
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.

Conditions

Infections, Rotavirus; Rotavirus Vaccines

Keywords

Placebo; Double blind; Gastroenteritis; Randomized; Oral live attenuated human rotavirus liquid vaccine

Outcome Measures

Primary Outcomes (1)

• Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody

  Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.

  At Month 3

Secondary Outcomes (7)

• Number of Seroconverted Subjects for Anti-RV IgA Antibody

  At Month 3

• Serum IgA Antibody Concentrations Against Rotavirus

  At Month 3

• Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea

  During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

• Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

  During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

• Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes

  From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3

Study Arms (3)

PLACEBO-ROTARIX-ROTARIX GROUP

EXPERIMENTAL

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Biological: Rotarix™; Biological: Placebo

ROTARIX-PLACEBO-ROTARIX GROUP

EXPERIMENTAL

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Biological: Rotarix™; Biological: Placebo

PLACEBO GROUP

PLACEBO COMPARATOR

Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Biological: Placebo

Interventions

Rotarix™ BIOLOGICAL

oral doses

PLACEBO-ROTARIX-ROTARIX GROUP; ROTARIX-PLACEBO-ROTARIX GROUP

Placebo BIOLOGICAL

oral dose

PLACEBO GROUP; PLACEBO-ROTARIX-ROTARIX GROUP; ROTARIX-PLACEBO-ROTARIX GROUP

Eligibility Criteria

• Age: 5 Weeks - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
• Birth weight of the subject should be \> 2000 grams.
• Written informed consent obtained from the parent or guardian of the subject.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) 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 within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.
• Concurrently participating in another clinical study, at any time during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

City of Muntinlupa, Philippines

Location

Related Publications (1)

• Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21.

  PMID: 21256876 BACKGROUND

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; Gastroenteritis

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: March 9, 2007
• Primary Completion: September 4, 2007
• Study Completion: September 4, 2007
• Last Updated: January 2, 2020
• Results First Posted: September 11, 2017

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

PH (1)