Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Public ClinicalTrials.gov record NCT00616421. 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 Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Study identification
- NCT ID
- NCT00616421
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,907 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 10 Years
- 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
- Mar 2008 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Oct 2009 (Actual)
- Last update posted
- Feb 15, 2016
2008 – 2009
United States locations
- U.S. sites
- 52
- U.S. states
- 17
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Investigational Reserach Program | Bentonville | Arkansas | 72712 | — |
| Arkansas Pediatric Research Group | Little Rock | Arkansas | 72205 | — |
| Premier Health Research Center | Downey | California | 90241 | — |
| Kaiser Permanente - Fremont | Fremont | California | 94538 | — |
| Kaiser Permanente - Fresno | Fresno | California | 93726 | — |
| Kaiser Permanente - Hayward | Hayward | California | 94545 | — |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | — |
| Kaiser Permanente - Pleasanton | Pleasanton | California | 94566 | — |
| Kaiser Permanente - San Francisco | San Francisco | California | 94115 | — |
| Kaiser Permanente - San Jose | San Jose | California | 95119 | — |
| Kaiser Permanente - Aurora | Aurora | Colorado | 80012 | — |
| 1st Allergy & Clinical Research | Centennial | Colorado | 80112 | — |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | — |
| 1st Allergy & Clinical Research | Thornton | Colorado | 80233 | — |
| Kaiser Permanente - Westminister | Westminister | Colorado | 80234 | — |
| Kentucky Pediatric Research Center | Bardstown | Kentucky | 40004 | — |
| Physicians to Children & Adolescents | Springfield | Kentucky | 40004 | — |
| Benchmark Research | Metairie | Louisiana | 70006 | — |
| St. Louis University School of Medicine | St Louis | Missouri | 63104 | — |
| Meridian Clinical Research LLC | Omaha | Nebraska | 68134 | — |
| Legacy Pediatrics | Rochester | New York | 14618 | — |
| Duke University Medical Center | Durham | North Carolina | 27704 | — |
| Durham Pediatrics | Durham | North Carolina | 27704 | — |
| Regional Pediatric Associates PA | Durham | North Carolina | 27704 | — |
| Odyssey Research | Fargo | North Dakota | 58103 | — |
| Dr. Senders and Associates | Cleveland | Ohio | 44121 | — |
| Calcagno Research & Development | Gresham | Oregon | 97030 | — |
| Children's Health Care - West | Erie | Pennsylvania | 16505 | — |
| University Of Pittsburgh Medical Center | Greenville | Pennsylvania | 16125 | — |
| Family Healthcare Partners | Grove City | Pennsylvania | 16127 | — |
| Pediatric Associates of Latrobe | Latrobe | Pennsylvania | 15650 | — |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15217 | — |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15220 | — |
| South Hills Pediatrics | Pittsburgh | Pennsylvania | 15227 | — |
| Pediatric Alliance PC | Pittsburgh | Pennsylvania | 15236 | — |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15237 | — |
| Primary Physicians Research Inc. | Pittsburgh | Pennsylvania | 15241 | — |
| Laurel Pediatrics | Uniontown | Pennsylvania | 15401 | — |
| Family Practice Medical Associates South | Upper Saint Clair | Pennsylvania | 15241 | — |
| Children's Community Pediatrics | Wexford | Pennsylvania | 15090 | — |
| Jackson Clinic Professional Association | Jackson | Tennessee | 38305 | — |
| Benchmark Research Ft. Worth | Fort Worth | Texas | 76135 | — |
| Benchmark Research San Angelo | San Angelo | Texas | 76904 | — |
| Jean Brown Research | Clinton | Utah | 84015 | — |
| Wee Care Pediatrics | Layton | Utah | 84041 | — |
| Cottonwood Pediatrics | Murray | Utah | 84107 | — |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research Inc. | Salt Lake City | Utah | 84121 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
| Copperview Medical Center | South Jordan | Utah | 84095 | — |
| Rockwood Clinic | Spokane | Washington | 99202 | — |
| Rockwood Clinic North | Spokane | Washington | 99218 | — |
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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00616421, 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 Feb 15, 2016 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00616421 live on ClinicalTrials.gov.