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

NCT ID: NCT00263653

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-09-30

Brief Summary

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.

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

Conditions

Haemophilus Influenzae Type b; Neisseria Meningitidis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Haemophilus influenzae type b- and meningococcal (vaccine)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Months
• Maximum Eligible Age: 14 Months
• 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

Almería, , Spain

GSK Investigational Site

Almería, , Spain

GSK Investigational Site

Antequera/Málaga, , Spain

GSK Investigational Site

Aravaca, , Spain

GSK Investigational Site

Blanes, , Spain

GSK Investigational Site

Burgos, , Spain

GSK Investigational Site

Lleida, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Marbella, , Spain

GSK Investigational Site

Mollet Del Valles/Barcelona, , Spain

GSK Investigational Site

Pamplona, , Spain

GSK Investigational Site

Sant Adriá de Beyós, Barcelona, , Spain

GSK Investigational Site

Sant Eugenia de Berga, Barcelona, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Vélez-Málaga, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 19952860 (View on PubMed)

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: Statistical Analysis Plan

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: Dataset Specification

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: Informed Consent Form

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

103954

Identifier Type: -

Identifier Source: org_study_id