Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

Study to Assess the Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine in Terms of Immunogenicity and Safety When Given to Healthy Infants at 2 and 4 Months of Age

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus
• Intervention / Treatment: Biological: Rotarix; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 854
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • GSK Investigational Site
• Colombia
  • Cali Colombia, Colombia
    • GSK Investigational Site
• Mexico
  • Mexico, D.F., Mexico, 14050
    • GSK Investigational Site
• Peru
  • Lima, Peru, Lima
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 at the time of the first vaccination.
• Written informed consent obtained from the parent or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• 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 planned use during the study period.
• Child is unlikely to remain in the study area for the duration of the study.
• Previous confirmed occurrence of rotavirus gastroenteritis.
• Gastroenteritis within 7 days preceding the study vaccine administration.
• Household contact with an immunosuppressed individual or pregnant woman.
• Use of antibiotics during the period starting from 7 days before dose 1 of vaccine(s).
• Planned administration of a vaccine (other than routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• 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.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease at time of enrollment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group HRV Lot A	Biological: Rotarix; Two oral doses.
Experimental: Group HRV Lot B	Biological: Rotarix; Two oral doses.
Experimental: Group HRV Lot C	Biological: Rotarix; Two oral doses.
Active Comparator: Group Placebo	Biological: Placebo; Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).	Two months after Dose 2.

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.	Two months after Dose 1.
Seroconversion rates to anti-rotavirus IgA antibody	Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).
Vaccine take rates in a subset of subjects.	Two months after each dose
Presence of rotavirus in stool samples in a subset of subjects	On the day of each vaccination and on planned days following each vaccination.
For each type of solicited symptom, occurrence of the symptom	During the 8-day follow-up period after each vaccine dose
Occurrence of unsolicited symptoms	During the 31-day follow-up period after each vaccine dose.
Occurrence of serious adverse events	Throughout the study period.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Lopez P, Herrera JFG, Cervantes Y, et al. Three consecutive production lots of the human monovalent RIX4414 G1P(8) rotavirus vaccine, Rotarix™ induce a consistent immune response in Latin American infants. Proc 4th World Congress Pediatr Infect Dis, Warsaw, Poland, 2005.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Gastroenteritis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Reoviridae Infections; Rotavirus Infections
• Other Study ID Numbers: 444563/033 (GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 444563/033
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register