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

Influenza Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700193
• Other study ID #: CSLCT-FLU-04-05
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: July 17, 2016
• Start date: March 2005

Study information

• Verified date: November 2008
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 8 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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

Locations

Country	Name	City	State
Australia	Murdoch Childrens Research Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No