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Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried

NCT02560272 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1560

Last updated 2015-09-25

No results posted yet for this study

Summary

The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.

Conditions

  • Haemophilus Influenzae Type b Infections

Interventions

BIOLOGICAL

Minhai-HIB

0.5ml, intramuscular

BIOLOGICAL

Act-HIB®

0.5ml, intramuscular

Sponsors & Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • shengli xia · Henan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2016-06-30

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 NCT02560272 on ClinicalTrials.gov