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Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)

NCT01554826 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2012-09-06

No results posted yet for this study

Summary

The clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months.

Conditions

Interventions

BIOLOGICAL

Influenza Split Vaccine

0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart

BIOLOGICAL

Inactivated Influenza Vaccine

0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart

Sponsors & Collaborators

  • Hualan Biological Engineering, Inc.

    lead INDUSTRY

Principal Investigators

  • Feng-cai Zhu, M.D. · Jiangsu Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-05-31
Completion
2010-02-28

Countries

  • China

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Entities

Diseases

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 NCT01554826 on ClinicalTrials.gov