Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197

September 20, 2016 updated by: GlaxoSmithKline

Study to Evaluate the Safety, Reactogenicity & Immunogenicity of a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™, vs Hib-MenC or Priorix™ Only, in Toddlers (13-14 m) Primed With 3 Doses of Hib (as Part of a DTPa -Containing Vaccine) & MenC-CRM197 Conjugate Vaccines.

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Biological: Haemophilus influenzae type b- and meningococcal (vaccine)

Detailed Description

This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain

Study Type

Interventional

Enrollment (Actual)

297

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Almería, Spain, 04009
    - GSK Investigational Site
  - Almería, Spain, 04007
    - GSK Investigational Site
  - Antequera/Málaga, Spain, 29200
    - GSK Investigational Site
  - Aravaca, Spain, 28023
    - GSK Investigational Site
  - Blanes, Spain
    - GSK Investigational Site
  - Burgos, Spain, 09005
    - GSK Investigational Site
  - Lérida, Spain, 25006
    - GSK Investigational Site
  - Madrid, Spain, 28034
    - GSK Investigational Site
  - Madrid, Spain, 28035
    - GSK Investigational Site
  - Marbella, Spain, 29600
    - GSK Investigational Site
  - Mollet del Valles/Barcelona, Spain, 08100
    - GSK Investigational Site
  - Pamplona, Spain, 31008
    - GSK Investigational Site
  - Sant Adriá de Beyós, Barcelona, Spain, 08930
    - GSK Investigational Site
  - Sant Eugenia de Berga, Barcelona, Spain, 08519
    - GSK Investigational Site
  - Sevilla, Spain, 41013
    - GSK Investigational Site
  - Velez, Malaga, Spain
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

Healthy male or female between, and including, 13 and 14 months of age.
Previously completed 3-dose primary vaccination with a MenC-CRM197 vaccine, and Hib (given as part of a combined DTPa-containing vaccine) with at least 6 months between the administration of the third doses and the study entry.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the study vaccine, or planned use during the study period.
Previous vaccination against OR history of H. influenzae type b (Hib) and/or meningococcal serogroup C disease and/or measles, mumps or rubella OR known exposure to measles, mumps or rubella within 30 days prior to the start of the present study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of any neurologic disorders or seizures.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including neomycine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Any grade 3 solicited symptoms (d 0 - 3)

Secondary Outcome Measures

Outcome Measure
Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Carmona A, Miranda M, Barrio F, De Vicente A, Mares J, Munoz E, Diez-Delgado J, Alonso A, Gimenez-Sanchez F, Merino J, Garcia-Corbeira P, Maechler G, Boutriau D; Spanish 103954 Study Group. Reactogenicity and immunogenicity of combined Haemophilus influenzae type b-meningococcal serogroup C conjugate vaccine booster dose coadministered with measles, mumps, and rubella vaccine. Pediatr Infect Dis J. 2010 Mar;29(3):269-71. doi: 10.1097/INF.0b013e3181c15977.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (ESTIMATE)

December 9, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

103954

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

Individual Participant Data Set
Information identifier: 103954

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: 103954

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 103954

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 103954

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 103954

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 103954

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.