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NCT02199691 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,715
- Enrollment target
NCT02199691: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT02199691 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 1,715 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1189% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02199691, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,715 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine. Primary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone. Secondary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone. * To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only. * To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap vaccine only. Observational objective: * To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV vaccines.
Primary Outcome
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Data for this outcome measure was not planned to be collected and analyzed f
Interventions
- BIOLOGICAL Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine
- BIOLOGICAL Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
- BIOLOGICAL Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- BIOLOGICAL GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,715 participants |
| Start Date | 2014-07-22 |
| Est. Completion | 2015-10-02 |
| Phase | Phase 2 |
What the finished NCT02199691 record still lists
NCT02199691 is an interventional study that assigns participants to a tested intervention. Its 1,715 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1189% higher).
The record links to 0 conditions, and to 4 interventions - of which Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine is the first listed.
NCT02199691 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02199691 about?
NCT02199691 is a clinical study titled "Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents". The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This stud...
What is the current status of trial NCT02199691?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,715 participants. The study started on 2014-07-22. Estimated completion is 2015-10-02.
What interventions are being tested in trial NCT02199691?
The interventions under investigation include: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine (BIOLOGICAL), Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (BIOLOGICAL), Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (BIOLOGICAL), GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02199691?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02199691's enrollment target sits among peer trials
1,715 11th of 2000 higher than 1,990 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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