Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Swine Flu, Flu, Vaccine, Children, Adjuvant
Eligibility Criteria
Inclusion Criteria:
- Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
For additional entry criteria, please refer to protocol.
Sites / Locations
- Premier Health Research Center, LLC
- Madera Family Medical Group
- Center for Clincal Trials, LLC
- Center for Clinical Trials, LLC
- Center for Clinical Trials of San Gabriel
- 1st International Research Centers
- Pediatrics and Adolescent Medicine
- Pediatrics and Adolescent Medicine
- Northern Illinois Research Associates
- Bluegrass Clinical Research, Inc.
- Heartland Research Associates LLC
- Heartland Research Associates LLC
- Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
- Meridien Clinical Research
- Clinical Research Center of Nevada
- Capital Pediatrics and Adolescent Ctr.
- Dr. Senders and Associates, Pediatrics
- Prestige Clinical Research
- IPS Research
- The Portland Clinic LLP
- Children's Health Care -West
- UPMC/Community Medicine (pediatrics)
- Pediatric Physicians Research, Inc.
- Pediatric Alliance - Greentree Division (pediatrics)
- Omega Clinical Research
- Holston Medical Group
- Research Across America
- West Houston Clinical Research Service
- Pediatric Healthcare of NW Houston
- J.Lewis Research, Inc./Foothill Family Clinic
- J. Lewis Research, Inc./Foothill Family Clinic South
- PI-Coor Clinical Research
- Virginia Commonwealth University
- Rockwood Research Center
- Instituto Nacional de Ciencias
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
3.75_(50)MF59
7.5_(0) MF59
7.5_(50) MF59
7.5_(100) MF59
15_(0) MF59
15_(50)MF59
15_(100) MF59
30_(0) MF59
3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22