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Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

NCT01494740 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2011-12-19

No results posted yet for this study

Summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.

Conditions

Interventions

BIOLOGICAL

split-virion, non-adjuvanted vaccine of 7.5 μg

120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

BIOLOGICAL

split-virion, non-adjuvanted vaccine of seasonal influenza

120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT01494740 on ClinicalTrials.gov