Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups

NCT01654809 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2012-10-02

No results posted yet for this study

Summary

The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.

Conditions

Interventions

BIOLOGICAL

evaluated vaccine

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

BIOLOGICAL

imported compared vaccine

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

BIOLOGICAL

domestic compared vaccine

0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

Sponsors & Collaborators

  • Beijing Center for Disease Control and Prevention

    lead OTHER_GOV

Principal Investigators

  • Nianmin Shi, Master · Beijing Chaoyang District Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • China

Study Locations

More Related Trials

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 NCT01654809 on ClinicalTrials.gov