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

NCT01152814 | Completed Phase 2 Results

• 2 other identifiers: V70_25S2010-018603-29
• Study Type: interventional
• Target: 64
• 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)

Arm 1

EXPERIMENTAL

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

Biological: Seasonal flu vaccine

Interventions

Seasonal flu vaccine BIOLOGICAL

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)

Arm 1

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.
• Able to comply with all the study requirements.
• In general good health

You may not qualify if:

• 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

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

Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b

Ferrara, 44100, Italy

Location

Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1

Genova, 16132, Italy

Location

Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37

Lanciano, 66034, Italy

Location

Centro 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

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: June 28, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 27, 2016
• Results First Posted: January 27, 2016

Record last verified: 2015-12

Locations

IT (6)