Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06131554
PHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

Official title: A Multicenter, Randomized, Double-blinded, Positive-controlled Phase Ⅲ Clinical Trial to Evaluate Lot-to-lot Consistency, Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1480

Start Date

2024-03-20

Completion Date

2025-12

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4)

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

batch 2 of MCV4

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

batch 3 of MCV4

1 dose of Menhycia (0.5ml) on Day 0, Intramuscular injection

BIOLOGICAL

Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

1 dose of Menactra (0.5ml) on Day 0, Intramuscular injection

Locations (1)

Husada Utama Hospital

Surabaya, Indonesia