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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Virus Vaccine

• Registration Number: NCT00700193
• Lead Sponsor: Seqirus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2006-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Status Verified: 2008-11
• Last Update Submitted: 2016-07-17
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Influenza Virus Vaccine	Equal to or greater 6 months to less than 3 years old
Group B	Influenza Virus Vaccine	Equal to or greater 3 years to less than 9 years old

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Murdoch Childrens Research Institute; 🇦🇺 Melbourne, Victoria, Australia