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NCT01049035 · ClinicalTrials.gov registry record · Phase 2
A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
A Phase 2 study of Meningitis and Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 580
- Enrollment target
- 20
- Study locations
NCT01049035: Completed Phase 2 study of Meningitis and Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01049035 is a Phase 2 study of Meningitis and Meningococcal Infection that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 580 participants, roughly in line with the 605-participant average among 7 other Meningitis trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01049035, a Phase 2 study of Meningitis and Meningococcal Infection, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 580 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease. Objectives: * To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. * To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.
Primary Outcome
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the prope
Conditions Studied
Interventions
- BIOLOGICAL Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
- BIOLOGICAL Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
- BIOLOGICAL M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
- BIOLOGICAL Varicella Virus Vaccine Live
- BIOLOGICAL Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Study Locations (20)
Kentucky
- - Bardstown
- - Crestview Hills
- - Louisville
- - Louisville
Alabama
- - Birmingham
- - Tuscaloosa
Arkansas
- - Jonesboro
- - Little Rock
California
- - Fountain Valley
- - Huntington Beach
Georgia
- - Marietta
- - Woodstock
Louisiana
- - Bossier City
North Carolina
- - Clyde
Ohio
- - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 580 participants |
| Start Date | 2009-12-16 |
| Est. Completion | 2012-02-13 |
| Phase | Phase 2 |
What the finished NCT01049035 record still lists
NCT01049035 is an interventional study that assigns participants to a tested intervention. The registered 580 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 605-participant average among 7 other Meningitis trials with a reported enrollment target.
The record links to 2 conditions, with Meningitis appearing as the primary indexed condition, and to 5 interventions - of which Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate is the first listed.
NCT01049035 names 20 study sites across 13 states, led by Kentucky, Alabama, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01049035 about?
NCT01049035 is a clinical study titled "A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers". The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the po...
What is the current status of trial NCT01049035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 580 participants. The study started on 2009-12-16. Estimated completion is 2012-02-13.
What conditions does trial NCT01049035 study?
This clinical trial studies the following conditions: Meningitis, Meningococcal Infection.
What interventions are being tested in trial NCT01049035?
The interventions under investigation include: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate (BIOLOGICAL), Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined) (BIOLOGICAL), M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live (BIOLOGICAL), Varicella Virus Vaccine Live (BIOLOGICAL), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01049035?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01049035 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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