Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011

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 2010-2011, When Administered to Elderly Subjects

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza
• Intervention / Treatment: Biological: Seasonal flu vaccine

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
  • Ferrara, Italy, 44100
    • Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
  • Genova, Italy, 16132
    • Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
  • Lanciano, Italy, 66034
    • Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
  • Lanciano, Italy
    • Centro Satellite. Distretto Sanitario di Base di Fossacesia in Via Polidoro-Vasto
  • Milano, Italy, 20127
    • Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.
• Able to comply with all the study requirements.
• In general good health

Key Exclusion Criteria:

• Any serious chronic or acute disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• Known or suspected impairment/alteration of immune function
• Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
• Fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit	Biological: Seasonal flu vaccine; This phase II is performed as a multicenters study site 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: till day 22)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	day 22
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).	day 22
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).	day 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Reported Solicited Local and Systemic Reactions	Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.	1 to 4 days post-vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vaccine; Seasonal influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V70_25S; 2010-018603-29 (EudraCT Number)