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Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

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ClinicalTrials.gov Identifier: NCT01651104
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : January 27, 2014
Last Update Posted : April 21, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Human Influenza
Intervention Biological: Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)
Enrollment 63
Recruitment Details Subjects were enrolled at one study center in Belgium.
Pre-assignment Details All enrolled subjects were included in the trial.
Arm/Group Title ≥65 Y
Hide Arm/Group Description Subjects ≥65 years of age who received one aTIV vaccination
Period Title: Overall Study
Started 63
Completed 63
Not Completed 0
Arm/Group Title ≥65 Y
Hide Arm/Group Description Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
Baseline analysis was performed on all enrolled subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants
70.5  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
28
  44.4%
Male
35
  55.6%
1.Primary Outcome
Title Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV
Hide Description

Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.

Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.

The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years).

Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
Arm/Group Title ≥65 Y
Hide Arm/Group Description:
Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1
59
(46 to 71)
A/H3N2
65
(52 to 77)
B
81
(69 to 90)
2.Primary Outcome
Title Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV
Hide Description

Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after 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 on the PP set.
Arm/Group Title ≥65 Y
Hide Arm/Group Description:
Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Ratio
A/H1N1
2.46
(1.93 to 3.12)
A/H3N2
2.68
(2.15 to 3.35)
B
4.44
(3.53 to 5.58)
3.Primary Outcome
Title Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV
Hide Description

Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).

This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years).

Time Frame Day 1 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the PP set.
Arm/Group Title ≥65 Y
Hide Arm/Group Description:
Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentages of subjects
A/H1N1 (Day 1)
56
(42 to 68)
A/H1N1 (Day 22)
97
(89 to 100)
A/H3N2 (Day 1)
49
(36 to 62)
A/H3N2 (Day 22)
94
(85 to 98)
B (Day 1)
19
(10 to 31)
B (Day 22)
87
(77 to 94)
4.Secondary Outcome
Title Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)
Hide Description Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.
Time Frame From day 1 through day 4 postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.
Arm/Group Title ≥65 Y
Hide Arm/Group Description:
Subjects ≥65 years of age who received one aTIV vaccination
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: Number of subjects
Injection site ecchymosis 3
Injection site erythema 7
Injection site induration 6
Injection site swelling 4
Injection site pain 22
Chills/shivering 0
Malaise 3
Myalgia 2
Arthralgia 2
Headache 4
Sweating (N=62) 2
Fatigue (N=62) 6
Fever (≥38°C) 0
Time Frame From day 1 through day 22.
Adverse Event Reporting Description Serious adverse events (SAEs) were collected from day 1 through day 22.
 
Arm/Group Title ≥65 Y
Hide Arm/Group Description Subjects ≥65 years of age who received one aTIV vaccination
All-Cause Mortality
≥65 Y
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
≥65 Y
Affected / at Risk (%) # Events
Total   0/63 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
≥65 Y
Affected / at Risk (%) # Events
Total   28/63 (44.44%)    
General disorders   
Injection site pain  1  22/63 (34.92%)  22
Injection site erythema  1  7/63 (11.11%)  7
Injection site induration  1  6/63 (9.52%)  6
Fatigue  1  6/63 (9.52%)  6
Injection site swelling  1  4/63 (6.35%)  4
Nervous system disorders   
Headache  1  4/63 (6.35%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01651104    
Other Study ID Numbers: V70_39S
2012-000085-38 ( EudraCT Number )
First Submitted: July 24, 2012
First Posted: July 26, 2012
Results First Submitted: July 11, 2013
Results First Posted: January 27, 2014
Last Update Posted: April 21, 2014