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

NCT01344057 | Completed Phase 2 Results

• 2 other identifiers: V70_32S2010-021841-38
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief Summary

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted Influenza Vaccine Administered to Elderly Subjects.

Conditions

Seasonal Influenza

Keywords

Seasonal Influenza, vaccine

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Number of Participants Who Reported Solicited Local and Systemic Reactions

  1 to 4 days post-vaccination

Study Arms (1)

Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine

OTHER

No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit

Biological: Seasonal Influenza Vaccine

Interventions

Seasonal Influenza Vaccine BIOLOGICAL

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) .

Sub unit, Inactivated, MF59C.1 Adjuvanted Influenza Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (6)

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio

Via Dei Vestini, Chieti, 66100, Italy

Location

Department of "Scienze della Salute" University of Genova Via Pastore 1

Genova, 16132, Italy

Location

Satellite: "ASL Lanciano - Vasto", sede legale Via S Spaventa 37

Lanciano, 66034, Italy

Location

Satellite: "Distretto Sanitario di Base di Fossacesia" in Via Polidoro-Vasto

Lanciano, Italy

Location

Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona 20

Milan, 20127, Italy

Location

Department of "malattie infettive" Ospedale San Gerardo, via Pergolesi 33

Monza, 20052, Italy

Location

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 28, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 28, 2023
• Results First Posted: January 28, 2016

Record last verified: 2023-04

Locations

IT (6)