A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
Sponsor study identifier
interventional
1,357
2 countries
35
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2009
Actual (reported)Study Completion
October 2010
Actual (reported)This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2, 2009
Actual (reported)September 9, 2009
Actual (reported)November 2009
Actual (reported)October 2010
Actual (reported)January 27, 2011
Actual (reported)Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Day 22, Day 29, Day 43, Day 202 and Day 387
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Day 22, Day 29, Day 43, Day 202 and Day 387
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Day 22, Day 29, Day 43
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 1, Day 22, Day 29, Day 43
Antibody Response Based on Baseline Seropositivity
Day 22, Day 29 and Day 43
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Day 1, Day 22, Day 29, Day 43
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
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Premier Health Research Center, LLC
Downey, California, 90241-4982, United States
Madera Family Medical Group
Madera, California, 93637, United States
Center for Clincal Trials, LLC
Paramount, California, 90723, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Center for Clinical Trials of San Gabriel
West Covina, California, 91790, United States
1st International Research Centers
Thornton, Colorado, 80233, United States
Pediatrics and Adolescent Medicine
Novartis Vaccines and Diagnostics
Novartis
1,357 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2009
First Posted
September 9, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
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
Contact the study team to confirm eligibility.
Marietta, Georgia, 30062, United States
Pediatrics and Adolescent Medicine
Woodstock, Georgia, 30189, United States
Northern Illinois Research Associates
DeKalb, Illinois, 60115, United States
Bluegrass Clinical Research, Inc.
New Albany, Indiana, 47150, United States
Heartland Research Associates LLC
Arkansas City, Kansas, 67005, United States
Heartland Research Associates LLC
Newton, Kansas, 67114, United States
Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
Louisville, Kentucky, 40291, United States
Meridien Clinical Research
Omaha, Nebraska, 68134, United States
Clinical Research Center of Nevada
Henderson, Nevada, 89015, United States
Capital Pediatrics and Adolescent Ctr.
Raleigh, North Carolina, 27609, United States
Dr. Senders and Associates, Pediatrics
Cleveland, Ohio, 44121, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
The Portland Clinic LLP
Beaverton, Oregon, 97006, United States
Children's Health Care -West
Erie, Pennsylvania, 16506, United States
UPMC/Community Medicine (pediatrics)
Greenville, Pennsylvania, 16125, United States
Pediatric Physicians Research, Inc.
Jefferson Hills, Pennsylvania, 15025, United States
Pediatric Alliance - Greentree Division (pediatrics)
Pittsburgh, Pennsylvania, 15220, United States
Omega Clinical Research
Warwick, Rhode Island, 02886, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Research Across America
Dallas, Texas, 75234, United States
West Houston Clinical Research Service
Houston, Texas, 77055, United States
Pediatric Healthcare of NW Houston
Tomball, Texas, 77375, United States
J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
PI-Coor Clinical Research
Burke, Virginia, 22015, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Rockwood Research Center
Spokane, Washington, 99202, United States
Instituto Nacional de Ciencias
Tlalpan, Mexico City, 14000, Mexico
Primary Completion
November 2009
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
April 14, 2016
Results First Posted
January 27, 2011
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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