A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Public ClinicalTrials.gov record NCT00384397. 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
An Immunogenicity and Safety Evaluation of Two Doses of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Given to Healthy Subjects at 9 and 12 Months of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age. Primary Objective: To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135. Secondary Objectives: Immunogenicity * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines. * To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine. Safety \- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
Study identification
- NCT ID
- NCT00384397
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,128 participants
Conditions and interventions
Conditions
Interventions
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine Biological
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Biological
Biological
Eligibility (public fields only)
- Age range
- 249 Days to 305 Days
- 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
- Aug 2008 (Actual)
- Completion
- Feb 2009 (Actual)
- Last update posted
- Apr 14, 2016
2006 – 2009
United States locations
- U.S. sites
- 39
- U.S. states
- 20
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Montgomery | Alabama | 36106 | — |
| Not listed | Fayetteville | Arkansas | 72703 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72202-3591 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Norwich | Connecticut | 06360 | — |
| Not listed | Cocoa Beach | Florida | 32931 | — |
| Not listed | Viera | Florida | 32955 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Woburn | Massachusetts | 01801 | — |
| Not listed | Bridgeton | Missouri | 63044 | — |
| Not listed | St Louis | Missouri | 63141 | — |
| Not listed | Las Vegas | Nevada | 89104 | — |
| Not listed | Rochester | New York | 14620 | — |
| Not listed | Syracuse | New York | 13210 | — |
| Not listed | Chapel Hill | North Carolina | 27514 | — |
| Not listed | Goldsboro | North Carolina | 27534 | — |
| Not listed | Laurinburg | North Carolina | 28352 | — |
| Not listed | Sylva | North Carolina | 28779 | — |
| Not listed | Cincinnati | Ohio | 45229-3039 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Columbus | Ohio | 43205 | — |
| Not listed | Tulsa | Oklahoma | 74127 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Sellersville | Pennsylvania | 18960 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Ogden | Utah | 84405 | — |
| Not listed | Pleasant Grove | Utah | 84062 | — |
| Not listed | Provo | Utah | 84604 | — |
| Not listed | Salt Lake City | Utah | 84123 | — |
| Not listed | Charlottesville | Virginia | 22911 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Norfolk | Virginia | 23510 | — |
| Not listed | Spokane | Washington | 99220 | — |
| Not listed | La Crosse | Wisconsin | 54601 | — |
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 NCT00384397, 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 Apr 14, 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 NCT00384397 live on ClinicalTrials.gov.