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A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

NCT02692859 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1992

Last updated 2017-09-20

Study results available
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Summary

Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.

Conditions

  • Haemophilus Influenza

Interventions

BIOLOGICAL

Hib conjugate vaccine

Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose

Sponsors & Collaborators

  • Chengdu Olymvax Biopharmaceuticals Inc.

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-08-31
Completion
2014-08-31

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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 NCT02692859 on ClinicalTrials.gov