Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
Public ClinicalTrials.gov record NCT01000974. 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
Phase III, Partially Double-blind Study to Evaluate Consistency and Immunogenicity of 3 Lots of GSK Biologicals' Hib Conjugate Vaccine 208108 Versus ActHIB and Pentacel at 2, 4, 6 and 15-18 Months of Age in Healthy Infants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Study identification
- NCT ID
- NCT01000974
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,003 participants
Conditions and interventions
Conditions
Interventions
- GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) Biological
- ActHIB™ Biological
- Pentacel™ Biological
- Pediarix™ Biological
- Prevnar 13™ Biological
- Rotarix™ Biological
- Engerix™-B Biological
- Infanrix™ 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
- Jun 18, 2010 (Type not available)
- Primary completion
- Nov 18, 2011 (Actual)
- Completion
- Jul 17, 2013 (Actual)
- Last update posted
- Jul 12, 2018
2010 – 2013
United States locations
- U.S. sites
- 63
- U.S. states
- 22
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Dothan | Alabama | 36305 | — |
| GSK Investigational Site | Benton | Arkansas | 72019 | — |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Anaheim | California | 92804 | — |
| GSK Investigational Site | Antioch | California | 94509 | — |
| GSK Investigational Site | Daly City | California | 94015 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Fremont | California | 94538 | — |
| GSK Investigational Site | Fresno | California | 93726 | — |
| GSK Investigational Site | Hayward | California | 94545 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Oakland | California | 94612 | — |
| GSK Investigational Site | Redwood City | California | 94063 | — |
| GSK Investigational Site | Roseville | California | 95661 | — |
| GSK Investigational Site | Sacramento | California | 95815 | — |
| GSK Investigational Site | Sacramento | California | 95823 | — |
| GSK Investigational Site | San Jose | California | 95119 | — |
| GSK Investigational Site | Santa Clara | California | 95051 | — |
| GSK Investigational Site | Santa Rosa | California | 95403 | — |
| GSK Investigational Site | Vallejo | California | 94589 | — |
| GSK Investigational Site | Walnut Creek | California | 94596 | — |
| GSK Investigational Site | West Covina | California | 91790 | — |
| GSK Investigational Site | Boulder | Colorado | 80304 | — |
| GSK Investigational Site | Colorado Springs | Colorado | 80922 | — |
| GSK Investigational Site | Orange City | Florida | 32763 | — |
| GSK Investigational Site | Marietta | Georgia | 30062 | — |
| GSK Investigational Site | Woodstock | Georgia | 30189 | — |
| GSK Investigational Site | Honolulu | Hawaii | 96819 | — |
| GSK Investigational Site | Waipio | Hawaii | 96797 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Louisville | Kentucky | 40291 | — |
| GSK Investigational Site | Fall River | Massachusetts | 02721 | — |
| GSK Investigational Site | Stevensville | Michigan | 49127 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55108 | — |
| GSK Investigational Site | Omaha | Nebraska | 68131 | — |
| GSK Investigational Site | Mineola | New York | 11501 | — |
| GSK Investigational Site | Syracuse | New York | 13210 | — |
| GSK Investigational Site | Utica | New York | 13502 | — |
| GSK Investigational Site | Fargo | North Dakota | 58103 | — |
| GSK Investigational Site | Canton | Ohio | 44718 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | — |
| GSK Investigational Site | Cleveland | Ohio | 44121 | — |
| GSK Investigational Site | Dayton | Ohio | 45406 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74107 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16505 | — |
| GSK Investigational Site | Greenville | Pennsylvania | 16125 | — |
| GSK Investigational Site | Hermitage | Pennsylvania | 16148 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Amarillo | Texas | 79124 | — |
| GSK Investigational Site | Fort Worth | Texas | 76107 | — |
| GSK Investigational Site | Houston | Texas | 77055 | — |
| GSK Investigational Site | Sugar Land | Texas | 77479 | — |
| GSK Investigational Site | Bountiful | Utah | 84010 | — |
| GSK Investigational Site | Layton | Utah | 84041 | — |
| GSK Investigational Site | Roy | Utah | 84067 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | — |
| GSK Investigational Site | South Jordan | Utah | 84095 | — |
| GSK Investigational Site | Syracuse | Utah | 84075 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01000974, 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 Jul 12, 2018 · 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 NCT01000974 live on ClinicalTrials.gov.