Clinical trial NCT01344057: Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Influenza
Keywords: Seasonal Influenza, vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 63
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.
* 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.

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