Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults
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 Adult Subjects 18 or More Years of Age
1 other identifier
interventional
2,719
2 countries
21
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
May 25, 2011
CompletedDecember 7, 2015
October 1, 2015
2 months
September 2, 2009
December 7, 2010
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Secondary Outcomes (8)
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
7 days after vaccination
- +3 more secondary outcomes
Study Arms (8)
3.75_(50)MF59
EXPERIMENTAL50% of MF59 with 3.75 µg A/H1N1 antigen
7.5 w/o MF59
EXPERIMENTAL0% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(50)MF59
EXPERIMENTAL50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59
EXPERIMENTAL100% of MF59 with 7.5 µg A/H1N1 antigen
15 w/o MF59
EXPERIMENTAL0% of MF59 with 15 µg A/H1N1 antigen
15_(50)MF59
EXPERIMENTAL50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59
EXPERIMENTAL100% of MF59 with 15 µg A/H1N1 antigen
30 w/o MF59
EXPERIMENTAL0% of MF59 with 30 µg A/H1N1 antigen
Interventions
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Eligibility Criteria
You may qualify if:
- Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
You may not qualify if:
- 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.
- Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
- For additional entry criteria, please refer to protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
- Novartis Vaccinescollaborator
Study Sites (21)
Miami Research Associates
Miami, Florida, 33143, United States
Johnson County Clin-Trials
Lenexa, Kansas, 66219, United States
Meridien Clinical Research
Omaha, Nebraska, 68134, United States
Regional Clinical Research
Endwell, New York, 13760, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Triangle Medical Research Associates
Cary, North Carolina, 27518, United States
Triangle Medical Research Associates
Raleigh, North Carolina, 27609, United States
Carolina Medical Trials
Winston-Salem, North Carolina, 27103, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
West Ridge Family Practice (adult)
Erie, Pennsylvania, 16506, United States
Primary Physicians Research Inc. (adult)
Jefferson Hills, Pennsylvania, 15025, United States
Omega Clinical Research
Warwick, Rhode Island, 02886, United States
Research Across America
Dallas, Texas, 75234, United States
West Houston Clinical Research Service
Houston, Texas, 77055, 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
PI Coor Clinical Research
Fairfax, Virginia, 22030, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Instituto Nacional de Ciencias
Tlalpan, 14000, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY DIRECTOR
Novartis Vaccine and Diagnostics
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 9, 2009
Study Start
September 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2010
Last Updated
December 7, 2015
Results First Posted
May 25, 2011
Record last verified: 2015-10