Clinical trial NCT00700193: A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 298
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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)
timeFrame: 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 outcomes:
measure: 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
timeFrame: 30 days after each vaccine dose
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Murdoch Childrens Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Terry M Nolan, Prof
role: PRINCIPAL_INVESTIGATOR
References: