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

Phase 2

Completed

• Conditions: Seasonal Influenza
• Interventions: Biological: Seasonal flu vaccine

• Registration Number: NCT01152814
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Study Completion: 2010-07
• Status Verified: 2015-12
• Results First Submitted: 2015-12-21
• Results First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Results First Posted: 2016-01-27
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Seasonal flu vaccine	No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD	day 22	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).
Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD	day 22	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 Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD	day 22	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Reported Solicited Local and Systemic Reactions	1 to 4 days post-vaccination	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.

Trial Locations

Locations (6)

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; 🇮🇹 Lanciano, Italy

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini; 🇮🇹 Chieti, Italy

Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b; 🇮🇹 Ferrara, Italy

Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1; 🇮🇹 Genova, Italy

Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20; 🇮🇹 Milano, Italy