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Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics

NCT00336453 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2009-12-17

No results posted yet for this study

Summary

The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.

Conditions

Interventions

BIOLOGICAL

Influenza Vaccination

0.5mL dose for intramuscular injection

BIOLOGICAL

Influenza Vaccination

0.25mL dose for intramuscular injection

Sponsors & Collaborators

  • Protein Sciences Corporation

    lead INDUSTRY

Principal Investigators

  • James C King, MD · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States

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 NCT00336453 on ClinicalTrials.gov