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

Primary Purpose

Seasonal Influenza

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Seasonal Influenza Vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring Seasonal Influenza, vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
  • Department of "Scienze della Salute" University of Genova Via Pastore 1
  • Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37
  • Satellite: "Distretto Sanitario di Base di Fossacesia" in Via Polidoro-Vasto
  • Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20
  • Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine

Arm Description

No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Outcomes

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
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
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
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
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.

Full Information

First Posted
April 21, 2011
Last Updated
April 27, 2023
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01344057
Brief Title
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 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 study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
Seasonal Influenza, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine
Arm Type
Other
Arm Description
No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit
Intervention Type
Biological
Intervention Name(s)
Seasonal Influenza Vaccine
Intervention Description
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) .
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
day 22
Title
Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Description
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).
Time Frame
day 22
Title
Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Description
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).
Time Frame
day 22
Secondary Outcome Measure Information:
Title
Number of Participants Who Reported Solicited Local and Systemic Reactions
Description
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.
Time Frame
1 to 4 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
City
Via Dei Vestini
State/Province
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Department of "Scienze della Salute" University of Genova Via Pastore 1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37
City
Lanciano
ZIP/Postal Code
66034
Country
Italy
Facility Name
Satellite: "Distretto Sanitario di Base di Fossacesia" in Via Polidoro-Vasto
City
Lanciano
Country
Italy
Facility Name
Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33
City
Monza
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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