Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01344057
First received: April 21, 2011
Last updated: December 21, 2015
Last verified: December 2015
  Purpose
This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.

Condition Intervention Phase
Seasonal Influenza
Biological: Seasonal Influenza Vaccine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2011-2012, When Administered to Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 22 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.

    Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.

    The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years).


  • Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 22 ] [ Designated as safety issue: No ]

    Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).

    The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years).


  • Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 22 ] [ Designated as safety issue: No ]

    Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).

    This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).



Secondary Outcome Measures:
  • Number of Participants Who Reported Solicited Local and Systemic Reactions [ Time Frame: 1 to 4 days post-vaccination ] [ Designated as safety issue: Yes ]
    Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.


Enrollment: 63
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Biological: Seasonal Influenza Vaccine
This phase II is performed as a multicenter study in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry.
  • Individuals able to comply with all the study requirements.
  • Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
  • Written informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.

Key Exclusion Criteria:

  • Individuals with any serious chronic or acute disease.
  • Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination.
  • Individuals with known or suspected impairment/alteration of immune function.
  • Individuals with known or suspected history of drug or alcohol abuse.
  • Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject.
  • Individuals within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.
  • Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
  • Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination.
  • Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
  • Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines.
  • Individuals who are part of study personnel or close family members conducting this study.
  • BMI > 35 kg/m2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344057

Locations
Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via dei Vestini, Chieti, Italy, 66100
Department of "Scienze della Salute" University of Genova Via Pastore 1
Genova, Italy, 16132
Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37
Lanciano, Italy, 66034
Satellite: "Distretto Sanitario di Base di Fossacesia" in Via Polidoro-Vasto
Lanciano, Italy
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20
Milano, Italy, 20127
Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33
Monza, Italy, 20052
Sponsors and Collaborators
Novartis Vaccines
  More Information

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01344057     History of Changes
Other Study ID Numbers: V70_32S  2010-021841-38 
Study First Received: April 21, 2011
Results First Received: December 21, 2015
Last Updated: December 21, 2015
Health Authority: European Union: European Medicines Agency

Keywords provided by Novartis:
Seasonal Influenza, vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016