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

Sponsor:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00700193

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Influenza Virus Vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

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) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 30 days after each vaccine dose ] [ Designated as safety issue: No ]

Enrollment:	298
Study Start Date:	March 2005
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A Equal to or greater 6 months to less than 3 years old	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
Group B Equal to or greater 3 years to less than 9 years old	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

Eligibility

Ages Eligible for Study:	6 Months to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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-Barré Syndrome;
Have a major congenital defect or serious illness and
Have a history of neurologic disorders or seizures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700193

Locations

Australia, Victoria
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia, 3052

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Terry M Nolan, Prof

Murdoch Childrens Research Institute

More Information

No publications provided

Responsible Party:	Dr Russell Basser, CSL Limited
ClinicalTrials.gov Identifier:	NCT00700193 History of Changes
Other Study ID Numbers:	CSLCT-FLU-04-05
Study First Received:	June 17, 2008
Last Updated:	November 6, 2008
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012