This Phase I/II study will evaluate the Safety, Reactogenicity and Immunogenicity of FluBlØk™ Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine, Administered Intramuscularly to Healthy Children Aged 6 to 59 Months
Approximately 300 healthy children, aged 6-59 months inclusive who meet the Inclusion/Exclusion Criteria, will be enrolled in this study. The target population is expected to reflect the community at large at each of the study sites. The Study Population will be evaluated as a whole and as two sub-groups:
- All study participants aged 6 to 35 months
- All study participants aged 36 to 59 months
The purpose of this study is to determine the safety, reactogenicity and immunogenicity of FluBlØk formulated as detailed above relative to TIV.
Our objective is to determine the optimal dose and dosing regime of FluBlØk for the two age groups participating in the study.
Primary Outcome Measures:
- To compare safety, reactogenicity and immunogenicity after each dose of two different formulations of FluBlØk to TIV in healthy children aged 6-35 months and one formulation of FluBlØk to TIV in healthy children aged 36-59 months.
Estimated Enrollment: |
300 |
Study Start Date: |
October 2006 |
Estimated Study Completion Date: |
April 2007 |
The study will be conducted as a randomized, prospective, parallel group, active controlled, observer and subject blinded trial. This study is a randomized, double-blinded, Phase I/II multi-center clinical trial to evaluate the safety, reactogenicity, and immunogenicity of FluBlØk or TIV in healthy children, aged 6-59 months inclusive. Subjects will be stratified by age either 6 to 35 months old inclusive or 36 to 59 months old inclusive. Within their age division, subjects will be randomized to receive either FluBlØk or TIV as noted in the table below. Subjects and staff will be blinded to vaccine product and dose given. FluBlØk will be compared to TIV for safety, reactogenicity and immunogenicity (measured by HAI antibody titer at day 28 and day 56). Subjects’ parents or guardians will be given a memory aid for reactogenicity events and data collected by a phone call one week following each vaccination. A final safety call will be made at approximately six months after the first vaccination.