deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT04358731

Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age (ACYWX-04)

A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

Sponsor: Serum Institute of India Pvt. Ltd.

Interventions Menactra NmCV-5
Updated 6 times since 2020 Last updated: Sep 4, 2021 Started: Dec 27, 2019 Primary completion: Mar 24, 2021 Completion: Mar 24, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2/PHASE3 clinical study on Vaccine for Meningococcal Disease, this trial is completed. The trial is conducted by Serum Institute of India Pvt. Ltd. and has accumulated 6 data snapshots since 2019. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~May 2020 – ~Jan 2021 · 8 months · monthly snapshotRecruiting~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Oct 2021 · 6 months · monthly snapshotActive Not Recruiting~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  3. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not RecruitingCompleted

  4. Apr 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: RecruitingActive Not Recruiting

  5. Jan 2021 — Apr 2021 [monthly]

    Recruiting PHASE2_PHASE3

Show 1 earlier version
  1. May 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

    First recorded

Dec 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Serum Institute of India Pvt. Ltd.
Data source: Serum Institute of India Pvt. Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .