Last reviewed · How we verify
NCT07135986
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
Phase 3 trial testing MenACYW conjugate vaccine in Meningococcal Infection in 1,602 participants. Participants enrolled and being followed up; not accepting new ones.
27 April 2026
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,602 |
| Start date | 26 September 2025 |
| Primary completion | 27 April 2026 |
| Estimated completion | 23 September 2026 |
| Sites | 4 locations across China |
Drugs / interventions tested
- MenACYW conjugate vaccine — full drug profile →
- MenACYW135 polysaccharide vaccine — full drug profile →
- MenAC conjugate vaccine — full drug profile →
Conditions studied
- Meningococcal Infection — all drugs for Meningococcal Infection →
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Sanofi — full company profile →
Who can join
Adults 2 to 17, any sex, with Meningococcal Infection or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Study details include: * The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07135986
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MenACYW conjugate vaccine
Trials testing the same drug.
- NCT06647407 — Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in · Phase 1, PHASE2 · active not recruiting
- NCT06284915 — Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers · Phase 3 · completed
- NCT06128733 — Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents · Phase 1, PHASE2 · completed
- NCT05929651 — Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Qua · Phase 4 · completed
- NCT03547271 — Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pedi · Phase 3 · completed
Other recruiting trials for Meningococcal Infection
Currently open trials in the same condition.
- NCT04843111 — Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® Du · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07135986 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07135986.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing