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Trial record 1 of 1 for:    QIV03
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Study of Quadrivalent Influenza Vaccine Among Adults

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ClinicalTrials.gov Identifier: NCT01218646
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : September 12, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative
Biological: Investigational Trivalent Inactivated Influenza Vaccine, No Preservative
Biological: Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative
Enrollment 739
Recruitment Details The study participants were enrolled from 08 October through 01 December 2010 in 12 clinic centers in the US.
Pre-assignment Details A total of 739 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
Period Title: Overall Study
Started 225 225 225 64
Completed 224 225 223 63
Not Completed 1 0 2 1
Reason Not Completed
Adverse Event             0             0             1             0
Lost to Follow-up             1             0             0             0
Protocol Violation             0             0             1             1
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine) Total
Hide Arm/Group Description Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine Total of all reporting groups
Overall Number of Baseline Participants 225 225 225 64 739
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 225 participants 225 participants 64 participants 739 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
64
 100.0%
64
   8.7%
>=65 years
225
 100.0%
225
 100.0%
225
 100.0%
0
   0.0%
675
  91.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 225 participants 225 participants 64 participants 739 participants
72.4  (5.7) 72.8  (5.6) 72.8  (5.3) 46.0  (11.6) 70.4  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 225 participants 225 participants 64 participants 739 participants
Female
129
  57.3%
121
  53.8%
126
  56.0%
27
  42.2%
403
  54.5%
Male
96
  42.7%
104
  46.2%
99
  44.0%
37
  57.8%
336
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 225 participants 225 participants 225 participants 64 participants 739 participants
225 225 225 64 739
1.Primary Outcome
Title Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines With Corresponding B Strain in Participants Aged 65 Years and Older.
Hide Description Immunogenicity outcomes were assessed in serum samples by hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to the influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens, including results reported as less or greater than lower limit of quantitation (<LLOQ or >ULOQ).
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
B/Brisbane/60/2008 (220, 0, 219, 0)
73.8
(63.9 to 85.3)
NA [1] 
(NA to NA)
57.9
(50.6 to 66.4)
B/Florida/04/2006 (220, 221, 0, 0)
61.1
(52.5 to 71.2)
54.8
(47.5 to 63.3)
NA [2] 
(NA to NA)
[1]
B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group
[2]
B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group
2.Primary Outcome
Title Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or After Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Hide Description Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers to the influenza vaccine B strains (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 0
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
B/Brisbane/60/2008 (220, 221, 0, 0)
73.8
(63.9 to 85.3)
42.2
(36.5 to 48.7)
NA [1] 
(NA to NA)
B/Florida/04/2006 (220, 0, 219, 0)
61.1
(52.5 to 71.2)
NA [2] 
(NA to NA)
28.5
(24.6 to 33.0)
[1]
B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group
[2]
B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group
3.Primary Outcome
Title Geometric Mean Titers Against the Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines (TIV) in Participants Aged 18 Years or Older
Hide Description Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers to the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1, Pre-vaccination
21.7
(17.9 to 26.3)
21.1
(17.5 to 25.5)
24.8
(20.4 to 30.1)
26.7
(17.7 to 40.2)
A/H1N1, Post-vaccination
231
(188 to 283)
271
(221 to 331)
269
(221 to 328)
728
(515 to 1030)
A/H3N2, Pre-vaccination
52.3
(42.1 to 65.0)
42.3
(34.9 to 51.4)
48.3
(40.0 to 58.4)
33.0
(22.1 to 49.1)
A/H3N2, Post vaccination
501
(422 to 593)
360
(302 to 429)
291
(243 to 347)
503
(361 to 701)
B/Brisbane, Pre-vaccination
27.1
(23.3 to 31.5)
28.5
(24.2 to 33.6)
29.0
(25.0 to 33.7)
18.9
(14.0 to 25.4)
B/Brisbane, Post-vaccination
73.8
(63.9 to 85.3)
42.2
(36.5 to 48.7)
57.9
(50.6 to 66.4)
97.7
(75.0 to 127)
B/Florida, Pre-vaccination
20.2
(17.5 to 23.3)
19.7
(17.2 to 22.6)
18.7
(16.4 to 21.3)
19.5
(14.5 to 26.3)
B/Florida, Post-vaccination
61.1
(52.5 to 71.2)
54.8
(47.5 to 63.3)
28.5
(24.6 to 33.0)
48.6
(35.5 to 66.4)
4.Other Pre-specified Outcome
Title Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines (TIV) With Corresponding B Strains in Participants Aged 65 Years and Older.
Hide Description

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as < 10.

Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respect to influenza vaccine B strains (corresponding B strains) was determined in randomized and vaccinated adult participants, per-protocol population
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 0
Measure Type: Number
Unit of Measure: Participants
B/Brisbane/60/2008 (220, 0, 219, 0) 63 NA [1]  41
B/Florida/04/2006 (220, 221, 0, 0) 73 69 NA [2] 
[1]
B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group
[2]
B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group
5.Other Pre-specified Outcome
Title Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines Without Corresponding B Strain in Participants Aged 65 Years and Older.
Hide Description

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥ 1:10 and ≥ four-fold increase in post-vaccination titers.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to influenza vaccine B Strains (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 0
Measure Type: Number
Unit of Measure: Participants
B/Brisbane/60/2008 (220, 221, 0, 0) 63 19 NA [1] 
B/Florida/04/2006 (220, 0, 219, 0) 73 NA [2]  20
[1]
B/Brisbane/60/2008 influenza virus antigen was not in the vaccine administered to this group.
[2]
B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group.
6.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years or Older.
Hide Description

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroprotection was defined as a pre-vaccination and post-vaccination titer ≥ 1:40 (l/dil)

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 59
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Pre-vaccination 70 70 78 27
A/H1N1 Post-vaccination 201 203 200 58
A/H3N2 Pre-vaccination 129 119 131 27
A/H3N2 Post-vaccination 220 212 209 57
B/Brisbane Pre-vaccination 101 108 108 21
B/Brisbane Post-vaccination 171 133 157 54
B/Florida Pre-vaccination 75 67 68 18
B/Florida Post-vaccination 161 149 101 38
7.Other Pre-specified Outcome
Title Seroconversion Against Influenza Virus Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines in Participants Aged 18 Years and Older
Hide Description

Immunogenicity outcomes were assessed in serum samples by HAI assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Seroconversion was defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 220 221 219 59
Measure Type: Number
Unit of Measure: Participants
A/A1N1 145 161 146 46
A/A3N2 152 139 122 50
B/Brisbane/60/2008 63 19 41 27
B/Florida/04/2006 73 69 20 18
8.Other Pre-specified Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or With Trivalent Influenza Vaccines.
Hide Description

Solicited injection site reactions: Pain, Erythema and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Grade 3 Injection site reactions: Pain - Significant; prevents daily activity; Erythema and Swelling >100 mm.

Grade 3 solicited systemic reactions: Fever (Temperature) ≥102.1°F; Headache, Malaise, and Myalgia - Significant; prevents daily activity.

Time Frame Day 0 up to day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
Overall Number of Participants Analyzed 225 225 225 64
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (224, 225, 224, 63) 73 52 64 31
Grade 3 Injection site Pain (224, 225, 224, 63) 2 0 0 0
Injection site Erythema (224, 224, 224, 63) 6 3 3 3
Grade 3 Injection site Erythema (224, 224, 224, 63 0 0 0 0
Injection site Swelling (224, 224, 224, 63) 4 0 3 5
Grade 3 Injection site Swelling (224, 224, 224, 63 0 0 0 0
Fever (224, 225, 223, 63) 3 2 0 2
Grade 3 Fever (224, 225, 223, 63) 1 1 0 0
Headache (224, 225, 224, 63) 30 26 26 16
Grade 3 Headache (224, 225, 224, 63) 1 1 0 1
Malaise (224, 225, 224, 63) 24 26 14 16
Grade Malaise (224, 225, 224, 63) 1 2 0 1
Myalgia (224, 225, 224, 63) 41 32 41 22
Grade 3 Myalgia (224, 225, 224, 63) 1 1 0 1
Time Frame Adverse events data were collected from Day 0 (post-vaccination) upto 21 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Hide Arm/Group Description Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
All-Cause Mortality
Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/225 (0.00%)      1/225 (0.44%)      2/225 (0.89%)      0/64 (0.00%)    
Eye disorders         
Retina detachment * 1  0/225 (0.00%)  0 0/225 (0.00%)  0 1/225 (0.44%)  1 0/64 (0.00%)  0
Infections and infestations         
Cellulitis * 1  0/225 (0.00%)  0 0/225 (0.00%)  0 1/225 (0.44%)  1 0/64 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma * 1  0/225 (0.00%)  0 1/225 (0.44%)  1 0/225 (0.00%)  0 0/64 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Group 1 (Investigational Quadrivalent Influenza Vaccine) Group 2 (Investigational Trivalent Influenza Vaccine) Group 3 (Licensed Trivalent Influenza Vaccine) Group 4 (Licensed Trivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/225 (32.44%)      52/225 (23.11%)      64/225 (28.44%)      31/64 (48.44%)    
General disorders         
Injection site pain * 1  73/224 (32.59%)  73 52/225 (23.11%)  52 64/224 (28.57%)  64 31/63 (49.21%)  31
Injection site Swelling * 1  4/224 (1.79%)  4 0/224 (0.00%)  0 3/224 (1.34%)  3 5/63 (7.94%)  5
Malaise  1  24/224 (10.71%)  24 14/224 (6.25%)  14 26/225 (11.56%)  26 16/63 (25.40%)  16
Musculoskeletal and connective tissue disorders         
Myalgia  1  41/224 (18.30%)  41 32/225 (14.22%)  32 41/224 (18.30%)  41 22/63 (34.92%)  22
Nervous system disorders         
Headache  1  30/224 (13.39%)  30 26/224 (11.61%)  26 26/225 (11.56%)  26 16/63 (25.40%)  16
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, version 13.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01218646     History of Changes
Other Study ID Numbers: QIV03
UTN: U1111-1113-3619 ( Other Identifier: WHO )
First Submitted: October 8, 2010
First Posted: October 11, 2010
Results First Submitted: July 3, 2013
Results First Posted: September 12, 2013
Last Update Posted: October 23, 2013