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

Haemophilus Influenzae Type b Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263653
• Other study ID #: 103954
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2005
• Last updated: September 20, 2016
• Start date: March 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: September 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Months to 14 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type b
• Neisseria Meningitidis

Intervention

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

Locations

Country	Name	City	State
Spain	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	Lérida
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	Sevilla
Spain	GSK Investigational Site	Velez, Malaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Carmona A, Miranda M, Barrio F, De Vicente A, Mares J, Muñoz E, Diez-Delgado J, Alonso A, Giménez-Sánchez F, Merino J, García-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any grade 3 solicited symptoms (d 0 - 3)
Secondary	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

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