Clinical trial NCT01152814: Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Influenza
Keywords: Seasonal influenza
Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


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.
* 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

Primary outcomes:
measure: 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
timeFrame: day 22
measure: Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
timeFrame: day 22
measure: Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
timeFrame: day 22
Secondary outcomes:
measure: Number of Participants Who Reported Solicited Local and Systemic Reactions
timeFrame: 1 to 4 days post-vaccination
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini
city: Ferrara
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b
city: Genova
country: Italy
facility: Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1
city: Lanciano
country: Italy
facility: Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37
city: Lanciano
country: Italy
facility: Centro Satellite. Distretto Sanitario di Base di Fossacesia in Via Polidoro-Vasto
city: Milano
country: Italy
facility: Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20
Study officials:
References: