Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
Primary Purpose
Pandemic Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Monovalent A/H1N1 influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pandemic Influenza focused on measuring Pandemic influenza, Vaccine
Eligibility Criteria
Inclusion Criteria:
- Males and females 18 years of age and above on the day of enrollment;
- Individuals in good health
- Individuals are able to comply with all study procedures
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion Criteria:
- Individual not able to comprehend and to follow all required study procedures;
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Any serious chronic or progressive disease according to judgment of the investigator
- History of any anaphylaxis, serious vaccine reactions, to any excipients.
- Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
- Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
- Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
- Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
- Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
- History of progressive or severe neurological disorders;
- Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
- Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
- Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
- Members of the research staff or their relatives.
Sites / Locations
- Gent, Antwerpen
- Munchen, Wurzburg, Balve, Leipzig, Magdeburg, Hamburg, Rostock, Mainz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
low dose of antigen + low dose of adjuvant
high dose of antigen + high dose of adjuvant
high dose of antigen
Arm Description
Outcomes
Primary Outcome Measures
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
Secondary Outcome Measures
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00971906
Brief Title
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
Official Title
A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pandemic Influenza
Keywords
Pandemic influenza, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
660 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low dose of antigen + low dose of adjuvant
Arm Type
Experimental
Arm Title
high dose of antigen + high dose of adjuvant
Arm Type
Experimental
Arm Title
high dose of antigen
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Monovalent A/H1N1 influenza vaccine
Intervention Description
This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant,or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups
Primary Outcome Measure Information:
Title
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
Time Frame
43 days after first vaccination
Secondary Outcome Measure Information:
Title
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria
Time Frame
3 weeks after booster vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females 18 years of age and above on the day of enrollment;
Individuals in good health
Individuals are able to comply with all study procedures
Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Exclusion Criteria:
Individual not able to comprehend and to follow all required study procedures;
History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
Any serious chronic or progressive disease according to judgment of the investigator
History of any anaphylaxis, serious vaccine reactions, to any excipients.
Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
History of progressive or severe neurological disorders;
Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
Members of the research staff or their relatives.
Facility Information:
Facility Name
Gent, Antwerpen
City
Antwerpen
Country
Belgium
Facility Name
Munchen, Wurzburg, Balve, Leipzig, Magdeburg, Hamburg, Rostock, Mainz
City
Mainz
Country
Germany
City
Basel
Country
Switzerland
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22446638
Citation
Hatz C, von Sonnenburg F, Casula D, Lattanzi M, Leroux-Roels G. A randomized clinical trial to identify the optimal antigen and MF59((R)) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. Vaccine. 2012 May 14;30(23):3470-7. doi: 10.1016/j.vaccine.2012.03.017. Epub 2012 Mar 22.
Results Reference
derived
Learn more about this trial
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age
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