Last reviewed · How we verify
NCT02864927
Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea
Phase 4 trial testing Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Meningitis in 1,311 participants. Completed in 12 June 2019.
12 June 2019
Quick facts
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,311 |
| Start date | 21 July 2016 |
| Primary completion | 12 June 2019 |
| Estimated completion | 12 June 2019 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine — full drug profile →
- Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine — full drug profile →
Conditions studied
- Meningitis — all drugs for Meningitis →
- Meningococcal Meningitis — all drugs for Meningococcal Meningitis →
- Meningococcal Infections — all drugs for Meningococcal Infections →
Sponsor
Sanofi Pasteur, a Sanofi Company — full company profile →
Who can join
Adults 9 Months to 55, any sex, with Meningitis or Meningococcal Meningitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: * To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra<sup>®</sup>) in the Republic of Korea, 2014-2019.
Kim HS, Engel S, Neveu D, Thollot Y, et al · · 2021 · cited 6× · PMID 33439463 · DOI 10.1007/s40121-020-00393-4
Verify or expand the search:
- PubMed search for NCT02864927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Trials testing the same drug.
- NCT05794230 — Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccine · Phase 3 · completed
- NCT04368429 — Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal · Phase 3 · completed
- NCT02752906 — Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine · Phase 3 · completed
Other recruiting trials for Meningitis
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT07332234 — Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies · recruiting
- NCT06995430 — A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years · Phase 3 · active not recruiting
- NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
- NCT06584864 — Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children. · NA · recruiting
Other Sanofi Pasteur, a Sanofi Company trials
Trials by the same sponsor.
- NCT07536048 — A Longitudinal Study of Epstein-Barr Virus (EBV) Reactivation in Adults Aged 18 to 29 Years · not yet recruiting
- NCT07222059 — Phase 3 Single Arm, Open Study on vYF in Adults · Phase 3 · completed
- NCT07013747 — Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne · Phase 1, PHASE2 · recruiting
- NCT06838000 — Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) i · Phase 3 · active not recruiting
- NCT06793826 — Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea · completed
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 NCT02864927 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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 Pasteur, a Sanofi Company
- Last refreshed: 25 April 2022
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/NCT02864927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing