Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

NCT00956761 | Completed Phase 2 Results

• 2 other identifiers: V70_09S2009-010586-23
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.

Conditions

Seasonal Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• 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 21), 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 21

• 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 21). The CHMP criterion was met if the geometric mean increase (GMR, day 21/day 0) in SRH antibody area is \>2.0 (≥65 years).

  day 21

• 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 0) and three weeks after FLUAD vaccination (day 21). This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years).

  day 21

• Number of Participants Who Reported Solicited Local and Systemic Reactions

  Safety was assessed for participants who reported solicited local and systemic reactions from day 0 up to and including day 3 after the FLUAD vaccination.

  0-3 days post-vaccination

Study Arms (1)

1

EXPERIMENTAL

Biological: Seasonal Influenza Vaccine (MF59C.1)

Interventions

Seasonal Influenza Vaccine (MF59C.1) BIOLOGICAL

1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010

1

Eligibility Criteria

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

You may qualify if:

• Subjects 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 disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• A proven hypersensitivity to any component of the study vaccine
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• 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 12 months, participants had received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine

Sponsors & Collaborators

• Novartis: lead
• Novartis Vaccines: collaborator

Study Sites (2)

Site 2: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37

Lanciano, 66034, Italy

Location

Site 3: Pianiga Distretto n. 2 - Area Sud - Azienda ULSS 13 Mirano-Via Nazionale 48

Pianiga, 30034, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics S.r.l

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

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: August 8, 2009
• First Posted: August 11, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 27, 2016
• Results First Posted: January 27, 2016

Record last verified: 2015-12

Locations

IT (2)