Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Public ClinicalTrials.gov record NCT00345579. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00345579
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,432 participants
Conditions and interventions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- 6 Weeks to 12 Weeks
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2006 (Type not available)
- Primary completion
- Oct 2007 (Actual)
- Completion
- Mar 2008 (Actual)
- Last update posted
- Dec 16, 2016
2006 – 2008
United States locations
- U.S. sites
- 61
- U.S. states
- 23
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | — |
| GSK Investigational Site | Birmingham | Alabama | 35244 | — |
| GSK Investigational Site | Benton | Arkansas | 72015 | — |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | — |
| GSK Investigational Site | Hot Springs | Arkansas | 71913 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72201 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Fresno | California | 93710 | — |
| GSK Investigational Site | Fresno | California | 93726 | — |
| GSK Investigational Site | Madera | California | 93637 | — |
| GSK Investigational Site | Slinas | California | 93901 | — |
| GSK Investigational Site | West Covina | California | 91790 | — |
| GSK Investigational Site | Boulder | Colorado | 80303 | — |
| GSK Investigational Site | Longmont | Colorado | 80501 | — |
| GSK Investigational Site | Plantation | Florida | 33324 | — |
| GSK Investigational Site | Nampa | Idaho | 208 463 3126 | — |
| GSK Investigational Site | Oak Lawn | Illinois | 60453 | — |
| GSK Investigational Site | Waukee | Iowa | 50263 | — |
| GSK Investigational Site | West Desmoines | Iowa | 50266 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Lexington | Kentucky | 40503 | — |
| GSK Investigational Site | Bossier City | Louisiana | 71111 | — |
| GSK Investigational Site | Boston | Massachusetts | 02111 | — |
| GSK Investigational Site | Jamaica Plain | Massachusetts | 02130 | — |
| GSK Investigational Site | Nies | Michigan | 49120 | — |
| GSK Investigational Site | Portage | Michigan | 49024 | — |
| GSK Investigational Site | Stevensville | Michigan | 49127 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55108 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89104 | — |
| GSK Investigational Site | New Hartford | New York | 13413 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Clyde | North Carolina | 28721 | — |
| GSK Investigational Site | Deerfield | North Carolina | 28607 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | — |
| GSK Investigational Site | Sylva | North Carolina | 28779 | — |
| GSK Investigational Site | Akron | Ohio | 44308-1062 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Cleveland | Ohio | 44121 | — |
| GSK Investigational Site | North Canton | Ohio | 44720 | — |
| GSK Investigational Site | South Euclid | Ohio | 44121 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15202 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15227 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | — |
| GSK Investigational Site | Wexford | Pennsylvania | 15090 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | — |
| GSK Investigational Site | Kingsport | Tennessee | 37664 | — |
| GSK Investigational Site | Houston | Texas | 77084 | — |
| GSK Investigational Site | Katy | Texas | 77450 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Ogden | Utah | 84405 | — |
| GSK Investigational Site | Orem | Utah | 84057 | — |
| GSK Investigational Site | Pleasant Gorve | Utah | 84062 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | — |
| GSK Investigational Site | South Jordan | Utah | 84095 | — |
| GSK Investigational Site | West Jordan | Utah | 84088 | — |
| GSK Investigational Site | Madison | Wisconsin | 53792 | — |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00345579, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 16, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00345579 live on ClinicalTrials.gov.