Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects

Haemophilus Influenzae Type b Clinical Trial

Official title:

Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323050
• Other study ID #: 102547
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2005
• Last updated: September 15, 2016
• Start date: November 2004
• Est. completion date: March 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 immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.

Description:

The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: March 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

• Having participated in the primary vaccination study 217744/097.

Exclusion criteria:

• Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097

• 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

Study Design

Allocation: Non-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	Alcorcon
Spain	GSK Investigational Site	Almeira
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Basurto/Bilbao
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Getafe
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Palma de Mallorca
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Velez, Malaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage (%) of subjects with anti-PRP antibody concentrations (conc) =1µg/ml and % of subjects with SBA-MenC titers = 128 one month post vaccination.
Secondary	Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP = 1,-PSC = 2, SBA-MenC = 128
Secondary	Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3
Secondary	Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.
Secondary	SAEs for whole study

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