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Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.

NCT04236960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-22

No results posted yet for this study

Summary

A single-center and open-labeled Phase I study, designed to evaluate the safety by observing the occurrence of adverse events and change of hematology, liver and renal function after vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy population aged 2 months to 55 years old.

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

Meningococcal Group ACYW135 Conjugate Vaccine

1 dose in Stage 1 (2\~55 yrs), 2 doses in Stage 2 (7\~23 mos), and 3 doses in Stage 3 (2\&3 mos)

Sponsors & Collaborators

  • Walvax Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Months
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2019-09-16
Completion
2019-11-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236960 on ClinicalTrials.gov