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

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 2011-2012, When Administered to Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344057
• Other study ID #: V70_32S
• Secondary ID: 2010-021841-38
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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: 63
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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.

• 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.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

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) .

Locations

Country	Name	City	State
Italy	Department of "Scienze della Salute" University of Genova Via Pastore 1	Genova
Italy	Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37	Lanciano
Italy	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	Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33	Monza
Italy	Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio	Via Dei Vestini	Chieti

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
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
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
Secondary	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.	1 to 4 days post-vaccination