Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
Public ClinicalTrials.gov record NCT01659996. 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 Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered to Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the study is to further characterize the safety and immunogenicity of Menactra® in the population \<2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of Pentacel®, a licensed pediatric vaccine. Primary Objectives: * To evaluate and compare the antibody responses to meningococcal serogroups A, C, Y, and W-135 induced by 2 injections of Menactra® in subjects aged 9 months at the first vaccination visit and 15 to 18 months at the second vaccination visit. * To evaluate and compare the antibody responses to Pertussis (pertussis toxoid \[PT\], filamentous haemagglutinin \[FHA\] and pertactin \[PRN\]) antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® administered alone. * To evaluate and compare the antibody responses to polyribosylribitol phosphate (PRP), tetanus and diphtheria antigens induced by a dose of Pentacel® when administered concomitantly with Menactra® to those elicited by a dose of Pentacel® alone. Observational Objectives: * To describe the safety profile (immediate unsolicited AEs within 30 minutes of each trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited AEs within 30 days of each vaccination, and serious adverse events \[SAEs\] throughout the course of the trial from Day 0 up to Day 30 after the last trial vaccination\[s\]) in all trial groups * To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by SBA HC, 30 days after the second Menactra® administration * To describe the antibody responses to Pentacel® (PT, FHA, PRN, FIM, diphtheria, tetanus, polio, PRP) measured by enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), or functional assays.
Study identification
- NCT ID
- NCT01659996
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,394 participants
Conditions and interventions
Conditions
Interventions
- Meningococcal polysaccharide diphtheria toxoid conjugate Biological
- Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed Biological
- Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate Biological
Biological
Eligibility (public fields only)
- Age range
- 9 Months to 18 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 2012 (Type not available)
- Primary completion
- Nov 2014 (Actual)
- Completion
- Sep 2015 (Actual)
- Last update posted
- Dec 15, 2015
2012 – 2015
United States locations
- U.S. sites
- 56
- U.S. states
- 22
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35235 | — |
| Not listed | Pinson | Alabama | 35126 | — |
| Not listed | Tucson | Arizona | 85741 | — |
| Not listed | Fayetteville | Arkansas | 72703 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Little Rock | Arkansas | 72205 | — |
| Not listed | Chino | California | 91710 | — |
| Not listed | Downey | California | 90241 | — |
| Not listed | La Puente | California | 91744 | — |
| Not listed | Lakewood | California | 90711 | — |
| Not listed | Paramount | California | 90723 | — |
| Not listed | Norwich | Connecticut | 06360 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Woodstock | Georgia | 30189 | — |
| Not listed | DeKalb | Illinois | 60115 | — |
| Not listed | Indianapolis | Indiana | 46256 | — |
| Not listed | Bossier City | Louisiana | 71111 | — |
| Not listed | Woburn | Massachusetts | 01801 | — |
| Not listed | Worcester | Massachusetts | 01655 | — |
| Not listed | Bridgeton | Missouri | 63044 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | Elkhorn | Nebraska | 68022 | — |
| Not listed | Lincoln | Nebraska | 68504 | — |
| Not listed | Lincoln | Nebraska | 68516 | — |
| Not listed | Omaha | Nebraska | 68198 | — |
| Not listed | Clyde | North Carolina | 28721 | — |
| Not listed | Fargo | North Dakota | 58103 | — |
| Not listed | Cincinnati | Ohio | 45245 | — |
| Not listed | Fairfield | Ohio | 45014 | — |
| Not listed | Huber Heights | Ohio | 45424 | — |
| Not listed | Kettering | Ohio | 45420 | — |
| Not listed | Tulsa | Oklahoma | 74127 | — |
| Not listed | Erie | Pennsylvania | 16505 | — |
| Not listed | Harleysville | Pennsylvania | 19438 | — |
| Not listed | Hermitage | Pennsylvania | 16148 | — |
| Not listed | Scranton | Pennsylvania | 18510 | — |
| Not listed | Sellersville | Pennsylvania | 18960 | — |
| Not listed | Jackson | Tennessee | 38305 | — |
| Not listed | Kingsport | Tennessee | 37660 | — |
| Not listed | Austin | Texas | 78705 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | Fort Worth | Texas | 76107 | — |
| Not listed | Houston | Texas | 77055 | — |
| Not listed | Hurst | Texas | 76054 | — |
| Not listed | San Antonio | Texas | 78229 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Layton | Utah | 84047 | — |
| Not listed | Murray | Utah | 84107 | — |
| Not listed | Orem | Utah | 84057 | — |
| Not listed | Payson | Utah | 84651 | — |
| Not listed | Roy | Utah | 84067 | — |
| Not listed | Spanish Fork | Utah | 84660 | — |
| Not listed | Syracuse | Utah | 84075 | — |
| Not listed | Midlothian | Virginia | 23113 | — |
| Not listed | Spokane | Washington | 99202 | — |
| Not listed | 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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01659996, 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 15, 2015 · 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 NCT01659996 live on ClinicalTrials.gov.