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NCT01659996 · ClinicalTrials.gov registry record · Phase 4
Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age
A Phase 4 study of Diphtheria and Tetanus, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,394
- Enrollment target
- 20
- Study locations
NCT01659996 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,394 participants, below the 1,774-participant average among 15 other Diphtheria trials with a reported enrollment target (21% lower). The trial reports 20 study locations across 11 states.
The verdict
NCT01659996, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,394 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL 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
Study Locations (20)
California
- - Chino
- - Downey
- - La Puente
- - Lakewood
- - Paramount
Arkansas
- - Fayetteville
- - Jonesboro
- - Little Rock
Alabama
- - Birmingham
- - Pinson
Georgia
- - Marietta
- - Woodstock
Massachusetts
- - Woburn
- - Worcester
Arizona
- - Tucson
Connecticut
- - Norwich
Illinois
- - DeKalb
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,394 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01659996
The ClinicalTrials.gov registry entry for NCT01659996 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,394 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,774-participant average among 15 other Diphtheria trials with a reported enrollment target (21% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Diphtheria appearing as the primary indexed condition, and to 3 interventions - of which Meningococcal polysaccharide diphtheria toxoid conjugate is the first listed.
NCT01659996 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT01659996 about?
NCT01659996 is a clinical study titled "Study of Menactra® in Healthy Subjects at 9 Months and Concomitantly With Pentacel® at 15 to 18 Months of Age". 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 evalua...
What is the current status of trial NCT01659996?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,394 participants. The study started on 2012-07. Estimated completion is 2015-09.
What conditions does trial NCT01659996 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Pertussis, Meningitis, Meningococcal Infection.
What interventions are being tested in trial NCT01659996?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01659996?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659996 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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