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

Primary Purpose

Infections, Rotavirus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Rotarix

Placebo

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Gastroenteritis

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Group HRV Lot A

Group HRV Lot B

Group HRV Lot C

Group Placebo

Arm Description

Outcomes

Primary Outcome Measures

Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).

Secondary Outcome Measures

Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.

Seroconversion rates to anti-rotavirus IgA antibody

Vaccine take rates in a subset of subjects.

Presence of rotavirus in stool samples in a subset of subjects

For each type of solicited symptom, occurrence of the symptom

Occurrence of unsolicited symptoms

Occurrence of serious adverse events

Full Information

NCT ID

NCT00757770

First Posted

September 22, 2008

Last Updated

September 6, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00757770

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

January 2004 (Actual)

Study Completion Date

January 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Rotavirus

Keywords

Gastroenteritis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

854 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group HRV Lot A

Arm Type

Experimental

Arm Title

Group HRV Lot B

Arm Type

Experimental

Arm Title

Group HRV Lot C

Arm Type

Experimental

Arm Title

Group Placebo

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Rotarix

Intervention Description

Two oral doses.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum anti-rotavirus Immunoglobulin A (IgA) antibody concentration expressed as Geometric Mean Concentrations (GMCs).

Time Frame

Two months after Dose 2.

Secondary Outcome Measure Information:

Title

Serum anti-rotavirus IgA antibody concentration expressed as GMCs in a subset of subjects.

Time Frame

Two months after Dose 1.

Title

Seroconversion rates to anti-rotavirus IgA antibody

Time Frame

Two months after Dose 1 (in a subset of subjects) and Dose 2 (all subjects).

Title

Vaccine take rates in a subset of subjects.

Time Frame

Two months after each dose

Title

Presence of rotavirus in stool samples in a subset of subjects

Time Frame

On the day of each vaccination and on planned days following each vaccination.

Title

For each type of solicited symptom, occurrence of the symptom

Time Frame

During the 8-day follow-up period after each vaccine dose

Title

Occurrence of unsolicited symptoms

Time Frame

During the 31-day follow-up period after each vaccine dose.

Title

Occurrence of serious adverse events

Time Frame

Throughout the study period.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

12 Weeks

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Cali Colombia

Country

Colombia

Facility Name

GSK Investigational Site

City

Mexico, D.F.

ZIP/Postal Code

14050

Country

Mexico

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima

Country

Peru

Facility Name

GSK Investigational Site

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

Citation

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.

Results Reference

result

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

444563/033

Available IPD/Information Comments

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

Learn more about this trial

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

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