Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
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
1 other identifier
interventional
468
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2004
Shorter than P25 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedSeptember 16, 2016
September 1, 2016
4 months
August 26, 2005
September 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage (%) of subjects with anti-PRP antibody concentrations (conc) ≥1µg/ml and % of subjects with SBA-MenC titers ≥ 128 one month post vaccination.
Secondary Outcomes (4)
Pre & 1M post vacc, S+/SP & conc/titer: SBA-MenC, anti-PSC,-PRP,-T & anti-PRP ≥ 1,-PSC ≥ 2, SBA-MenC ≥ 128
Pre vacc, S+/SP & conc/titer: anti-D,-PT,-FHA,-PRN,-HBs, -polio 1,2,3
Loc, gen sympt: D 0-3, unsol sympt: D 0-30 post vacc.
SAEs for whole study
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or female between, and including, 13 and 14 months of age
- Having participated in the primary vaccination study 217744/097.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (16)
GSK Investigational Site
Alcorcón, 28922, Spain
GSK Investigational Site
Almeira, 4009, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Barcelona, 08950, Spain
GSK Investigational Site
Basurto/Bilbao, 48013, Spain
GSK Investigational Site
Burgos, 09005, Spain
GSK Investigational Site
Getafe, 28905, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28047, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Móstoles/Madrid, 28935, Spain
GSK Investigational Site
Palma de Mallorca, 07014, Spain
GSK Investigational Site
Valladolid, 47010, Spain
GSK Investigational Site
Vélez-Málaga, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2005
First Posted
May 9, 2006
Study Start
November 1, 2004
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.