Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 88 of 112 for:    mf59

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01152814
Recruitment Status : Completed
First Posted : June 29, 2010
Results First Posted : January 27, 2016
Last Update Posted : January 27, 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 Seasonal Influenza
Intervention Biological: Seasonal flu vaccine
Enrollment 64
Recruitment Details Overall, 64 participants ≥65 years of age were enrolled at 5 sites in Italy.
Pre-assignment Details Blood samples for the determination of antibody titers were obtained prior to vaccination.
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Period Title: Overall Study
Started 64
Completed 62
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Overall Number of Baseline Participants 64
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who were enrolled and randomized into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants
73.3  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
34
  53.1%
Male
30
  46.9%
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 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).

Time Frame day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Overall Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
45
(32 to 58)
A/H3N2
61
(48 to 73)
B
27
(17 to 40)
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 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).

Time Frame day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using the PP dataset.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Overall Number of Participants Analyzed 62
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
A/H1N1
1.96
(1.59 to 2.42)
A/H3N2
1.88
(1.64 to 2.16)
B
1.32
(1.22 to 1.43)
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 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).

Time Frame day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using the PP dataset.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Overall Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
97
(89 to 100)
A/H3N2
71
(58 to 82)
B
100
(94 to 100)
4.Secondary Outcome
Title Number of Participants Who Reported Solicited Local and Systemic Reactions
Hide Description Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines.
Time Frame 1 to 4 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.
Arm/Group Title FLUAD
Hide Arm/Group Description:
Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: Number of participants
Injection site ecchymosis (N= 62) 2
Injection site erythema (N= 62) 4
Injection site induration (N= 62) 2
Injection site swelling (N= 62) 0
Injection site pain (N= 62) 15
Chills/Shivering (N= 62) 2
Malaise (N= 62) 2
Myalgia (N= 62) 7
Arthralgia (N= 62) 4
Headache (N= 62) 5
Sweating (N= 62) 7
Fatigue (N= 62) 5
Fever (≥38°C) (N= 59) 0
Time Frame From Day 1 through Day 22.
Adverse Event Reporting Description Adverse events other than local and systemic reactions or solicited reactions lasting longer than 4 days after vaccination were documented during the study period. Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.
 
Arm/Group Title FLUAD
Hide Arm/Group Description Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
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   
Fatigue * 1  2/64 (3.13%) 
Malaise * 1  1/64 (1.56%) 
Infections and infestations   
Bronchitis * 1  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/64 (1.56%) 
Nervous system disorders   
Headache * 1  2/64 (3.13%) 
Paraesthesia * 1  1/64 (1.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01152814     History of Changes
Other Study ID Numbers: V70_25S
2010-018603-29 ( EudraCT Number )
First Submitted: June 28, 2010
First Posted: June 29, 2010
Results First Submitted: December 21, 2015
Results First Posted: January 27, 2016
Last Update Posted: January 27, 2016