Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00345579 · ClinicalTrials.gov registry record · Phase 3
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
A Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,432
- Enrollment target
- 20
- Study locations
NCT00345579 is a Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,432 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT00345579, a Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,432 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Conditions Studied
Interventions
- BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
- BIOLOGICAL ActHIB
- BIOLOGICAL Pediarix/Infanrix Penta
Study Locations (20)
Arkansas
- GSK Investigational Site - Benton
- GSK Investigational Site - Fayetteville
- GSK Investigational Site - Hot Springs
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - Little Rock
- GSK Investigational Site - Little Rock
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Fresno
- GSK Investigational Site - Fresno
- GSK Investigational Site - Madera
- GSK Investigational Site - Slinas
- GSK Investigational Site - West Covina
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
Colorado
- GSK Investigational Site - Boulder
- GSK Investigational Site - Longmont
Florida
- GSK Investigational Site - Plantation
Idaho
- GSK Investigational Site - Nampa
Illinois
- GSK Investigational Site - Oak Lawn
Iowa
- GSK Investigational Site - Waukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,432 participants |
| Start Date | 2006-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00345579
The ClinicalTrials.gov registry entry for NCT00345579 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,432 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neisseria Meningitidis appearing as the primary indexed condition, and to 3 interventions - of which GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 is the first listed.
NCT00345579 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Arkansas, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT00345579 about?
NCT00345579 is a clinical study titled "Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age". The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome...
What is the current status of trial NCT00345579?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,432 participants. The study started on 2006-09. Estimated completion is 2008-03.
What conditions does trial NCT00345579 study?
This clinical trial studies the following conditions: Neisseria Meningitidis, Haemophilus Influenzae Type b.
What interventions are being tested in trial NCT00345579?
The interventions under investigation include: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014 (BIOLOGICAL), ActHIB (BIOLOGICAL), Pediarix/Infanrix Penta (BIOLOGICAL).
Who is sponsoring clinical trial NCT00345579?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00345579 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neisseria Meningitidis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
COMPLETED · Phase 3
-
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
RECRUITING · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.