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A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA

NCT00958243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2018-05-23

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Conditions

Interventions

BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine (CSL425)

0.5 mL intramuscular injection on Day 0 and Day 21

BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine (CSL425)

0.25 mL intramuscular injection on Day 0 and Day 21

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Director Vaccines · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-11-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00958243 on ClinicalTrials.gov