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Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

NCT01047202 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2013-03-15

No results posted yet for this study

Summary

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

Conditions

Interventions

BIOLOGICAL

Pandemic influenza A/H1N1 vaccine

Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

BIOLOGICAL

Pandemic influenza A/H1N1 vaccine

Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

BIOLOGICAL

Seasonal trivalent vaccine

Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • China

Study Locations

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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 NCT01047202 on ClinicalTrials.gov