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

NCT ID: NCT00757770

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 854 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-01-31

Brief Summary

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.

Conditions

Infections, Rotavirus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group HRV Lot A

Group Type: EXPERIMENTAL

Rotarix

Intervention Type: BIOLOGICAL

Two oral doses.

Group HRV Lot B

Group Type: EXPERIMENTAL

Rotarix

Intervention Type: BIOLOGICAL

Two oral doses.

Group HRV Lot C

Group Type: EXPERIMENTAL

Rotarix

Intervention Type: BIOLOGICAL

Two oral doses.

Group Placebo

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

Interventions

Rotarix

Two oral doses.

Intervention Type: BIOLOGICAL

Placebo

Two oral doses; The placebo consist of all components of the study vaccine i.e. excipients and buffer, but no RV particles.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Cali Colombia, , Colombia

GSK Investigational Site

Mexico City, , Mexico

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

, ,

Countries

Colombia; Mexico; Peru

References

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.

Reference Type: RESULT

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

444563/033

Identifier Type: -

Identifier Source: org_study_id