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

NCT00992212 | Completed Phase 2

• 1 other identifier: V111_04
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Pandemic Influenza Disease

Keywords

Pandemic influenza; vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (5)

Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59)

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59)

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Group C (7.5mcg HA+ full dose MF59)

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV)

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV)

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Interventions

Monovalent A/H1N1 influenza vaccine BIOLOGICAL

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.

Group A (Seasonal TIV + 7.5mcg HA+ full dose MF59); Group B (Ajuvanted Seasonal TIV + 7.5mcg HA+ full dose MF59); Group C (7.5mcg HA+ full dose MF59); Group D (7.5mcg HA+ full dose MF59 + Seasonal TIV); Group E (3.75mcg HA+ ½ dose MF59+ Seasonal TIV)

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (5)

01

Chieti, Italy

Location

05

Ferrara, Italy

Location

04

Genova, Italy

Location

02

Lanciano, Italy

Location

03

Mira 30034 Pianiga,, Italy

Location

Related Publications (1)

• Gasparini R, Schioppa F, Lattanzi M, Barone M, Casula D, Pellegrini M, Veitch K, Gaitatzis N. Impact of prior or concomitant seasonal influenza vaccination on MF59-adjuvanted H1N1v vaccine (Focetria) in adult and elderly subjects. Int J Clin Pract. 2010 Mar;64(4):432-8. doi: 10.1111/j.1742-1241.2009.02309.x. Epub 2009 Dec 17.

  PMID: 20039974 RESULT

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 1, 2016

Record last verified: 2012-01

Locations

IT (5)