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Comparative Immunogenicity Study of Two Hepatitis A Vaccines

NCT03231605 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-08-01

No results posted yet for this study

Summary

Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Hepatitis A Vaccine

Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Sponsors & Collaborators

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2017-08-31
Completion
2017-12-29

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 NCT03231605 on ClinicalTrials.gov