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

• ClinicalTrials.gov Identifier: NCT00734734
• Recruitment Status: Completed
• First Posted: August 14, 2008
• Results First Posted: January 28, 2016
• Last Update Posted: January 28, 2016
• Sponsor: Novartis Vaccines
• Information provided by (Responsible Party): Novartis ( Novartis Vaccines )

Study Description

Brief Summary:

Trial for annual approval of interpandemic influenza vaccines

Condition or disease	Intervention/treatment	Phase
Interpandemic Influenza	Biological: Seasonal Influenza Vaccine	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009, When Administered to Elderly Subjects
• Study Start Date: June 2008
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: July 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1	Biological: Seasonal Influenza Vaccine; 1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: day 21 ]

   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).

2. Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ]

   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).

3. Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ]

   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).

4. Number of Participants Who Reported Solicited Local and Systemic Reactions [ Time Frame: 0 to 3 days post-vaccination ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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

Contacts and Locations

Locations

Italy

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

Lanciano, Italy, 66034

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

Pianiga, Italy, 30034

Sponsors and Collaborators

Novartis Vaccines

Investigators

• Study Chair: Novartis Vaccines; Novartis Vaccines

More Information

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT00734734
• Other Study ID Numbers: V70P7S; 2008-001047-19
• First Posted: August 14, 2008
• Results First Posted: January 28, 2016
• Last Update Posted: January 28, 2016
• Last Verified: December 2015

Keywords provided by Novartis ( Novartis Vaccines ):

Prophylaxis of Influenza; Influenza Vaccines; MF59C.1

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases