Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10
November 30, 2016 updated by: Novartis Vaccines
A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of an Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above
This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects aged 18 years and above.
This study will explore the effect of the previous and concomitant exposure to a seasonal influenza vaccination to the immunogenicity and safety profile of two different doses of an adjuvanted H1N1sw vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years).
Total duration of the study is eight weeks, which include two weeks for enrolment and 6 weeks for study participation.
Vaccinations were to be administered on day 1 and day 22.
Blood samples were collected at day 1 (baseline, before the first vaccination), at day 22 (before the second vaccination), at day 29 (one week after the second vaccination) and at day 43 (three weeks after the second vaccination).
Sera were tested by Hemagglutination Inhibition (HI) and Microneutralization (MN) assays.
Safety was assessed until 3 weeks after the first and second vaccination.
Study Type
Interventional
Enrollment (Actual)
418
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chieti, 66100, Italy
- 01
-
Ferrara 44100, Italy
- 05
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Genova 16132, Italy
- 04
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Lanciano,66034, Italy
- 02
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Mira 30034 Pianiga,, Italy
- 03
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- For study Groups A and B : subjects aged 18 years and above on the day of enrollment, who took part to the seasonal trials for the 2009/10 vaccine registration; For study Groups C to E: subjects aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines;
- Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator;
- Documented consent obtained after the nature of the study has been explained according to local regulatory requirements;
- Individuals are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
- 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:
- Individuals who are not able to comprehend and to follow all required study procedures; individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1;
- Individuals who have had documented confirmed or suspected influenza disease within 6 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;
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study and individuals who have ever received blood, blood products and/or plasma derivatives in the past 12 weeks;
- Individuals with axillary temperature ≥ 38.0°C within 3 days of study vaccination;
Known or suspected impairment/alteration of immune function, for example resulting from:
- receipt of immunosuppressive therapy,
- cancer chemotherapy,
- receipt of immunostimulants within 60 days prior to Visit 1,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
- known HIV infection or HIV-related disease.
- Surgery planned during the study period;
- If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry;
- Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination.
- Members of the research staff or their relatives (research staff are individuals with direct or indirect contact with trial subjects, or study site personnel who have access to any study documents containing subject information, including: e.g. receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians); hospital personnel and health care providers not involved in the study can be enrolled.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59)
|
This trial will be performed at multiple sites; appr.
160 subjects exposed to the annual vaccine registration will be invited to take part into this study.
In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
|
|
Experimental: Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59)
|
This trial will be performed at multiple sites; appr.
160 subjects exposed to the annual vaccine registration will be invited to take part into this study.
In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
|
|
Experimental: Group C (7.5mcg HA+ full dose MF59)
|
This trial will be performed at multiple sites; appr.
160 subjects exposed to the annual vaccine registration will be invited to take part into this study.
In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
|
|
Experimental: Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV)
|
This trial will be performed at multiple sites; appr.
160 subjects exposed to the annual vaccine registration will be invited to take part into this study.
In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
|
|
Experimental: Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV)
|
This trial will be performed at multiple sites; appr.
160 subjects exposed to the annual vaccine registration will be invited to take part into this study.
In addition, a total of 224 healthy subjects not yet exposed to the seasonal influenza vaccines will be enrolled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the immunogenicity, safety and tolerability of 1 and 2 IM doses of MF59-H1N1sw flu vaccine in adult-elderly subjects previously exposed to 09/10 NH TIV and in those not yet vaccinated against flu season 09/10.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
October 8, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V111_04
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