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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: Completed Phase 3 study of Neisseria Meningitidis and Haemophilus Influenzae Type b, sponsored by GlaxoSmithKline.

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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (474% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Conditions Studied

Neisseria Meningitidis Haemophilus Influenzae Type b

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

FieldValue
Enrollment Target 4,432 participants
Start Date 2006-09
Est. Completion 2008-03
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT00345579 record still lists

NCT00345579 is an interventional study that assigns participants to a tested intervention. Its 4,432 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (474% higher).

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 names 20 study sites across 8 states, led by 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

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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.

Where NCT00345579's enrollment target sits among peer trials

4,432 56th of 2000 higher than 1,945 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00345579, the US trial registry maintained by the National Library of Medicine. NCT00345579 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.