A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population.
- Conditions
- Influenza, humanTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-004820-69-Outside-EU/EEA
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 300
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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: 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 Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: 30 days after each vaccine dose.