Trials / Completed
CompletedNCT04368429
Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Immunogenicity and Safety of a Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 2 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Detailed description
The duration of each participant's participation in the study was approximately 30 to 44 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) | Pharmaceutical form: Liquid solution Route of administration: IM |
| BIOLOGICAL | Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Pharmaceutical form: Liquid solution Route of administration: IM |
Timeline
- Start date
- 2020-05-22
- Primary completion
- 2020-11-07
- Completion
- 2020-11-07
- First posted
- 2020-04-29
- Last updated
- 2025-09-15
- Results posted
- 2021-10-06
Locations
4 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04368429. Inclusion in this directory is not an endorsement.