Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Public ClinicalTrials.gov record NCT00345683. 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
Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent 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 booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study identification
- NCT ID
- NCT00345683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,021 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
- PedvaxHIB Biological
- Prevnar Biological
- M-M-R II Biological
- Varivax Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Months to 15 Months
- 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
- Jul 2007 (Type not available)
- Primary completion
- Sep 2008 (Actual)
- Completion
- Nov 2008 (Actual)
- Last update posted
- Nov 29, 2016
2007 – 2008
United States locations
- U.S. sites
- 55
- U.S. states
- 21
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Birmingham | Alabama | 35244 | — |
| GSK Investigational Site | Benton | Arkansas | 72015 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| 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 | 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 | 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 | Ithaca | New York | 14850 | — |
| GSK Investigational Site | New Hartford | New York | 13413 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | — |
| GSK Investigational Site | Boardman | Ohio | 44512 | — |
| 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 | Erie | Pennsylvania | 16505 | — |
| GSK Investigational Site | Greenville | Pennsylvania | 16125 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15217 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15220 | — |
| 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 | 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 | Salt Lake City | Utah | 84121 | — |
| 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 NCT00345683, 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 Nov 29, 2016 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00345683 live on ClinicalTrials.gov.