NCT00700193

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

July 19, 2016

Status Verified

November 1, 2008

Enrollment Period

1.3 years

First QC Date

June 17, 2008

Last Update Submit

July 17, 2016

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • Safety of CSL Influenza Virus Vaccine in a Paediatric population through the assessment of the frequency of Local and general solicited symptoms, Unsolicited Adverse Events (UAE),Serious Adverse Events (SAEs)

    Local & general solicited symptoms for 7 days post each vaccination, UAEs for 30 days post each vaccination, SAEs for 6 months after the last primary vaccination and 6 months after the booster vaccination

Secondary Outcomes (1)

  • Evaluate immunogenicity response to CSL Influenza Virus Vaccine in Paediatric population according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines

    30 days after each vaccine dose

Study Arms (2)

Group A

OTHER

Equal to or greater 6 months to less than 3 years old

Biological: Influenza Virus Vaccine

Group B

OTHER

Equal to or greater 3 years to less than 9 years old

Biological: Influenza Virus Vaccine

Interventions

Influenza Virus VaccineBIOLOGICAL

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

Group A

Eligibility Criteria

Age6 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Be healthy male or female children, aged = or \> 6 months to \< 9 years at the time of first study vaccination; Note: = or \> 6 refers to 6 calendar months
  • Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
  • Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
  • Be born after a normal gestation period (between 36 and 42 weeks).

You may not qualify if:

  • Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
  • Previous influenza vaccination;
  • Clinical signs of active infection and/or an axillary temperature of = or \>37.5 degrees Celsius or oral temperature of = or \>38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
  • Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
  • Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:
  • Chronic or long term corticosteroids: \>0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).
  • Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
  • Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
  • Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
  • Have a known history of Guillain-BarrĂ© Syndrome;
  • Have a major congenital defect or serious illness and
  • Have a history of neurologic disorders or seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Murdoch Childrens Research Institute

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Terry M Nolan, Prof

    Murdoch Childrens Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

March 1, 2005

Primary Completion

June 1, 2006

Last Updated

July 19, 2016

Record last verified: 2008-11

Locations

AU(1)