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
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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 Disease Meningococcal Serogroup Diseases |
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. |
- Any grade 3 solicited symptoms (d 0 - 3)
- 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
| Estimated Enrollment: | 297 |
| Study Start Date: | March 2005 |
-
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
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 |
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| 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, 28035 | |
| GSK Investigational Site | |
| Madrid, Spain, 28034 | |
| GSK Investigational Site | |
| Marbella, Spain, 29600 | |
| 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 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00263653 History of Changes |
| Other Study ID Numbers: | 103954 |
| Study First Received: | December 8, 2005 |
| Last Updated: | November 8, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 17, 2013