A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

NCT00700193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2016-07-19

No results posted yet for this study

Summary

The purpose of this study is to determine the Safety, Tolerability \& Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.

Conditions

Interventions

BIOLOGICAL

Influenza Virus Vaccine

2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose

BIOLOGICAL

Influenza Virus Vaccine

2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Terry M Nolan, Prof · Murdoch Childrens Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-06-30

Countries

  • Australia

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 NCT00700193 on ClinicalTrials.gov