Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

NCT00734734 | Completed Phase 2 Results

• 2 other identifiers: V70P7S2008-001047-19
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

Trial for annual approval of interpandemic influenza vaccines

Conditions

Interpandemic Influenza

Keywords

Prophylaxis of Influenza; Influenza Vaccines; MF59C.1

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 to 3 days post-vaccination

Study Arms (1)

1

EXPERIMENTAL

Biological: Seasonal Influenza Vaccine

Interventions

Seasonal Influenza Vaccine BIOLOGICAL

1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation

1

Eligibility Criteria

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

You may qualify if:

• 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, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
• A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, they have received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
• Within the past 4 weeks participants had received another vaccine; any investigational agent
• An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, sede legale

Lanciano, 66034, Italy

Location

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 13, 2008
• First Posted: August 14, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 28, 2016
• Results First Posted: January 28, 2016

Record last verified: 2015-12

Locations

IT (2)