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

NCT ID: NCT00700193

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 298 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: OTHER

Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

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

Group Type: OTHER

Influenza Virus Vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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

2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;

3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and

4. Be born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria

1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;

2. Previous influenza vaccination;

3. 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;

4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);

5. 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).

6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;

7. 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;

8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;

9. Have a known history of Guillain-Barré Syndrome;

10. Have a major congenital defect or serious illness and

11. Have a history of neurologic disorders or seizures

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seqirus

INDUSTRY

Sponsor Role: lead

Responsible Party

CSL Limited

Principal Investigators

Terry M Nolan, Prof

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

Murdoch Childrens Research Institute

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

CSLCT-FLU-04-05

Identifier Type: -

Identifier Source: org_study_id