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

Study to Evaluate Clinical Consistency of the Liquid Formulation of GSK Biologicals' HRV Vaccine and to Evaluate Liquid Formulation Compared to Lyophilised Formulation of the HRV Vaccine Administered as a Two-dose Primary Vaccination.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00382772

Enrollment

1200

Registered

2006-10-02

Start date

2006-11-30

Completion date

2007-08-31

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus

Keywords

HRV vaccine, Diarrhoea, Rotavirus

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.

Interventions

BIOLOGICAL2-dose oral live attenuated G1P[8] human rotavirus vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

11 Weeks to 17 Weeks

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assess lot-to-lot consistency in terms of reactogenicity and assess safety of HRV vaccines.	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026