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

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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:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Interpandemic Influenza
Intervention Biological: Seasonal Influenza Vaccine
Enrollment 64
Recruitment Details Overall, 64 participants ≥65 years of age were enrolled at 2 sites in Italy.
Pre-assignment Details Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
Period Title: Overall Study
Started 64
Completed 64
Not Completed 0
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
Baseline analysis population was defined as all participants who were enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants
73.1  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
32
  50.0%
Male
32
  50.0%
1.Primary Outcome
Title 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
Hide Description

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).

Time Frame day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) analysis set included all enrolled participants who had received the relevant dose of vaccine correctly on Day 0, provided evaluable serum samples with the relevant time windows, and had no major protocol violations.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
38
(26 to 50)
A/H3N2
55
(42 to 67)
B
42
(30 to 55)
2.Primary Outcome
Title Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Hide Description

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).

Time Frame day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using PP set.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
A/H1N1
1.87
(1.5 to 2.33)
A/H3N2
3.74
(2.73 to 5.11)
B
2.38
(1.81 to 3.13)
3.Primary Outcome
Title Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD
Hide Description

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).

Time Frame day 21
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using PP set.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
Overall Number of Participants Analyzed 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
89
(79 to 95)
A/H3N2
75
(63 to 85)
B
80
(68 to 89)
4.Primary Outcome
Title Number of Participants Who Reported Solicited Local and Systemic Reactions
Hide Description 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.
Time Frame 0 to 3 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: Number of participants
Injection site ecchymosis (N= 59) 0
Injection site erythema (N= 64) 10
Injection site induration (N= 64) 2
Injection site swelling (N= 59) 0
Injection site pain (N= 64) 11
Chills shivering (N= 64) 0
Malaise (N= 64) 0
Myalgia (N= 64) 1
Arthralgia (N= 64) 0
Headache (N= 64) 2
Sweating (N= 64) 1
Fatigue (N= 64) 2
Fever (≥38°C) (N= 64) 0
Time Frame From Day 0 through Day 21.
Adverse Event Reporting Description Adverse events other than local and systemic reactions or solicited reactions lasting longer than 3 days after vaccination were documented during the study period. Analysis was done using the safety dataset; participants in the exposed population who provided post-vaccination safety data.
 
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2008/2009 influenza season into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
All-Cause Mortality
FLUAD
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FLUAD
Affected / at Risk (%)
Total   0/64 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FLUAD
Affected / at Risk (%)
Total   4/64 (6.25%) 
General disorders   
Induration * 1  1/64 (1.56%) 
Injection site erythema * 1  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders   
Myalgia * 1  1/64 (1.56%) 
Nervous system disorders   
Headache * 1  1/64 (1.56%) 
Skin and subcutaneous tissue disorders   
Erythema * 1  2/64 (3.13%) 
Hyperhidrosis * 1  1/64 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis’ agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics S.r.l
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00734734     History of Changes
Other Study ID Numbers: V70P7S
2008-001047-19
First Submitted: August 13, 2008
First Posted: August 14, 2008
Results First Submitted: December 21, 2015
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016