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

Seasonal Influenza Clinical Trial

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 2010-2011, When Administered to Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152814
• Other study ID #: V70_25S
• Secondary ID: 2010-018603-29
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2010
• Last updated: December 21, 2015
• Start date: June 2010
• Est. completion date: July 2010

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

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)

Locations

Country	Name	City	State
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	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	Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes