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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263653
First received: December 8, 2005
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Haemophilus Influenzae Type b
Neisseria Meningitidis
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Any grade 3 solicited symptoms (d 0 - 3)

Secondary Outcome Measures:
  • 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

Enrollment: 297
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
    Other Name: 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

  Eligibility

Ages Eligible for Study:   13 Months to 14 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263653

Locations
Spain
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information