A Study in Infants to Test Two Preparations (Freeze-dried or Liquid) of the Rotavirus Vaccine (HRV Vaccine).

NCT00382772 | Completed Phase 3

• 1 other identifier: 107876
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 12

Brief Summary

The aim of this this study is to evaluate the lot-to-lot consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate the liquid formulation compared to the lyophilised formulation of GSK Biologicals' HRV vaccine when administered concomitantly with a combination childhood vaccine.

Conditions

Infections, Rotavirus

Keywords

HRV vaccine; Diarrhoea; Rotavirus

Outcome Measures

Primary Outcomes (1)

• Demonstrate lot-to-lot consistency of HRV vaccine liquid formulation and non-inferiority of liquid formulation versus the lyophilised formulation of the HRV vaccine.

Secondary Outcomes (1)

• Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.

Interventions

2-dose oral live attenuated G1P[8] human rotavirus vaccine BIOLOGICAL

Eligibility Criteria

• Age: 11 Weeks - 17 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants birth weigh \>2000 g, 11 -17 weeks old at Dose 1 with written informed consent.

You may not qualify if:

• Allergic reaction to vaccine components; clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol; immunocompromised.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Espoo, 02100, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kotka, 48600, Finland

Location

GSK Investigational Site

Lahti, 15140, Finland

Location

GSK Investigational Site

Oulu, 90100, Finland

Location

GSK Investigational Site

Pori, 28120, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vantaa, 01300, Finland

Location

GSK Investigational Site

Vantaa, 01600, Finland

Location

Related Publications (1)

• Vesikari T, Karvonen A, Bouckenooghe A, Suryakiran PV, Smolenov I, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants. Vaccine. 2011 Mar 3;29(11):2079-84. doi: 10.1016/j.vaccine.2011.01.004. Epub 2011 Jan 14.

  PMID: 21238572 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; Diarrhea

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 2, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: August 1, 2007
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

FI (12)