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A Study of Influenza Virus Vaccines in Children and Adults

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ClinicalTrials.gov Identifier: NCT00988143
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 12, 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: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: 2009-2010 Trivalent Influenza Virus Vaccine
Biological: 2008-2009 Trivalent Influenza Virus Vaccine
Biological: Quadrivalent Influenza Virus Vaccine
Enrollment 600
Recruitment Details The study participants were enrolled from 01 October through 05 November 2009 in 4 clinical centers in the US.
Pre-assignment Details A total of 600 participants who met all the inclusion criteria and none of the exclusion criteria were enrolled, randomized and vaccinated in the study.
Arm/Group Title Study Group 1 (2009-2010 TIV) Study Group 2 (2008-2009 TIV) Study Group 3 (QIV)
Hide Arm/Group Description Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives) Participants received the 2008-2009 Trivalent Influenza Vaccine Participants received the Quadrivalent Influenza Vaccine
Period Title: Overall Study
Started 220 190 190
Completed 220 190 190
Not Completed 0 0 0
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine) Total
Hide Arm/Group Description Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV) Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV) Participants received the Quadrivalent Influenza Vaccine (QIV) Total of all reporting groups
Overall Number of Baseline Participants 220 190 190 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants 190 participants 190 participants 600 participants
<=18 years
30
  13.6%
0
   0.0%
0
   0.0%
30
   5.0%
Between 18 and 65 years
127
  57.7%
135
  71.1%
123
  64.7%
385
  64.2%
>=65 years
63
  28.6%
55
  28.9%
67
  35.3%
185
  30.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 220 participants 190 participants 190 participants 600 participants
47.8  (24.9) 54.9  (17.5) 56.7  (17.2) 52.9  (20.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants 190 participants 190 participants 600 participants
Female
144
  65.5%
124
  65.3%
130
  68.4%
398
  66.3%
Male
76
  34.5%
66
  34.7%
60
  31.6%
202
  33.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 220 participants 190 participants 190 participants 600 participants
220 190 190 600
1.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
Hide Description

Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.

(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.

(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.

Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia & Shivering: Significant, prevents daily activity.

Time Frame Day 0 up to 7 days post-vaccination
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Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 220 190 190
Measure Type: Number
Unit of Measure: Participants
Injection site Tenderness (15, 0, 0) 4 0 0
Grade 3 Injection site Tenderness (15, 0, 0) 0 0 0
Injection site Pain (205, 190, 190) 105 82 90
Grade 3 Injection site Pain (206, 190, 190) 1 0 1
Injection site Erythema (220, 190, 190) 7 3 2
Grade 3 Injection site Erythema (220, 190, 190) 0 0 0
Injection site Swelling (220, 190, 190) 10 2 1
Grade 3 Injection site Swelling (220, 190, 190) 0 0 0
Injection site Induration (190, 190, 190) 3 1 1
Grade 3 Injection site Induration (190, 190, 190) 0 0 0
Injection site Ecchymosis (190, 190, 190) 1 1 1
Grade 3 Injection site Ecchymosis (190, 190, 190) 0 0 0
Fever (220, 190, 190) 2 1 0
Grade 3 Fever (220, 190, 190) 0 0 0
Vomiting (15, 0, 0) 0 0 0
Grade 3 Vomiting (15, 0, 0) 0 0 0
Malaise (205, 190, 190) 30 23 20
Grade 3 Malaise (205, 190, 190) 3 1 2
Appetite lost (15, 0, 0) 1 0 0
Grade 3 Appetite lost (15, 0, 0) 0 0 0
Drowsiness (15, 0, 0) 4 0 0
Grade 3 Drowsiness (15, 0, 0) 0 0 0
Crying abnormal (15, 0, 0) 1 0 0
Grade 3 Crying abnormal (15, 0, 0) 0 0 0
Headache (205, 189, 190) 35 34 30
Grade 3 Headache (205, 189, 190) 1 0 1
Irritability (15, 0, 0) 5 0 0
Grade 3 Irritability (15, 0, 0) 0 0 0
Myalgia (205, 190, 190) 50 32 45
Grade 3 Myalgia (205, 190, 190) 0 0 0
Shivering (190, 190, 190) 10 6 5
Grade 3 Shivering (190, 190, 190) 0 0 0
2.Primary Outcome
Title Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
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 21 Days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 187 188 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
B/Brisbane/60/2008 (187, 0, 190)
114
(97.8 to 134)
NA [1] 
(NA to NA)
101
(85.6 to 120)
B/Florida/04/2006 (0, 188, 190)
NA [2] 
(NA to NA)
135
(117 to 156)
155
(133 to 180)
[1]
B/Brisbane influenza virus antigen not in the vaccine administered to this group
[2]
B/Florida influenza virus antigen not in the vaccine administered to this group
3.Primary Outcome
Title Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
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 21 Days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 375 0 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/Brisbane/59/2007(A1N1) [N = 375, 0, 190]
151
(134 to 171)
161
(137 to 189)
A/Uruguay/716/2007(H3N2) [N = 375, 0, 190]
339
(239 to 392)
304
(249 to 370)
4.Other Pre-specified Outcome
Title Number of Adult Participants With Seroprotection Against Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine
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 to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil)

Time Frame Day 0 (pre-vaccination) and Day 21 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against the influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 187 188 190
Measure Type: Number
Unit of Measure: Participants
A/H1N1, Pre-vaccination (186, 188, 190) 84 77 81
A/H1N1, Post-vaccination (187, 188, 190) 168 173 176
A/H3N2, Pre-vaccination (186, 187, 190) 83 91 93
A/H3N2, Post-vaccination (187, 188, 190) 180 177 180
B/Brisbane/60/2008, Pre-vaccination (186, 0, 190) 80 NA [1]  69
B/Brisbane/60/2008, Post-vaccination (187, 0, 190) 168 NA [1]  162
B/Florida/04/2006, Pre-vaccination (0, 187, 190) NA [2]  97 89
B/Florida/04/2006, Post-vaccination (0, 187, 190) NA [2]  174 175
[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 Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Adult Participants
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 21 Days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 187 188 190
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1, Pre-vaccination (186, 188, 190)
27.5
(22.8 to 33.0)
28.4
(23.6 to 34.3)
27.6
(22.7 to 33.6)
A/H1N1, Post-vaccination (187, 188, 190)
145
(122 to 173)
157
(132 to 187)
161
(137 to 189)
A/H3N2, Pre-vaccination (186, 188, 190)
29.9
(24.0 to 37.2)
32.7
(25.8 to 41.6)
38.5
(29.7 to 49.9)
A/H3N2, Post-vaccination (187, 188, 190)
302
(250 to 365)
380
(305 to 472)
304
(249 to 370)
B/Brisbane/60/2008, Pre-vaccination (186, 0, 190)
22.0
(18.5 to 26.2)
NA [1] 
(NA to NA)
19.9
(16.7 to 23.7)
B/Brisbane/60/2008, Post-vaccination (187, 0, 190)
114
(97.8 to 134)
NA [1] 
(NA to NA)
101
(85.6 to 120)
B/Florida/04/2006, Pre-vaccination (0, 187, 190)
NA [2] 
(NA to NA)
32.6
(27.4 to 38.7)
27.1
(22.5 to 32.6)
B/Florida/04/2006, Post-vaccination (0, 187, 190)
NA [2] 
(NA to NA)
135
(117 to 156)
155
(133 to 180)
[1]
B/Brisbane/60/2008 influenza virus antigen not in the vaccine administered to this group.
[2]
B/Florida/04/2006 influenza virus antigen not in the vaccine administered to this group.
6.Other Pre-specified Outcome
Title Number of Adult Participants With Seroconversion to Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Hide Description Seroconversion to vaccine antigens was defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time Frame Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respect to vaccine antigens were determined in randomized and vaccinated participants, per-protocol population.
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 187 188 190
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (187, 188, 190) 103 97 112
A/H3N2 (187, 188, 190) 130 120 119
B/Brisbane/60/2008 (187, 0, 190) 104 NA [1]  101
B/Florida/04/2006 (0, 188, 190) NA [2]  83 110
[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.
7.Other Pre-specified Outcome
Title Geometric Mean Titers Against the Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Study Participants
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 21 Days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 215 188 189
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1, Pre-vaccination (214, 186, 189)
27.0
(22.8 to 32.1)
27.8
(23.1 to 33.6)
25.4
(21.0 to 30.8)
A/H1N1, Post-vaccination (214, 187, 189)
153
(131 to 179)
145
(123 to 172)
143
(122 to 168)
A/H3N2, Pre-vaccination (214, 187, 189)
30.5
(25.1 to 37.2)
34.6
(27.7 to 43.3)
37.8
(29.8 to 47.9)
A/H3N2, Post-vaccination (214, 188, 189)
285
(244 to 334)
330
(271 to 401)
263
(219 to 316)
B/Brisbane/60/2008, Pre-vaccination (214, 0, 189)
15.5
(13.4 to 18.0)
NA [1] 
(NA to NA)
16.2
(13.9 to 18.8)
B/Brisbane/60/2008, Post-vaccination (215, 0, 189)
76.7
(66.6 to 88.4)
NA [1] 
(NA to NA)
75.6
(64.8 to 88.2)
B/Florida/04/2006, Pre-vaccination (0, 186, 189)
NA [2] 
(NA to NA)
26.6
(22.8 to 31.1)
21.7
(18.3 to 25.7)
B/Florida/04/2006, Post-vaccination (0, 187, 189)
NA [2] 
(NA to NA)
96.5
(84.0 to 111)
109
(94.5 to 125)
[1]
B/Brisbane/60/2008 influenza virus antigen was not in vaccine administered to this group.
[2]
B/Florida/04/2006 influenza virus antigen was not in vaccine administered to this group.
8.Other Pre-specified Outcome
Title Number of Participants With Seroconversion to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Hide Description Seroconversion to vaccine antigens were defined as a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.
Time Frame Day 0 up to 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respects to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 215 188 189
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Pre-vaccination (214, 186, 189) 88 71 70
A/H1N1 Post-vaccination (213, 186, 189) 118 90 112
A/H3N2 Pre-vaccination (214, 187, 189) 100 94 92
A/H3N2 Post-vaccination (213, 187, 189) 148 119 116
B/Brisbane/60/2008 Pre-vaccination (214, 0, 189) 57 NA [1]  50
B/Brisbane/60/2008 Post-vaccination (214, 0, 189) 111 NA [1]  99
B/Florida/04/2006 Pre-vaccination (0, 186, 189) NA [2]  80 67
B/Florida/04/2006 Post-vaccination (0, 186, 189) NA [3]  79 100
[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]
B/Florida/04/2006 influenza virus antigen was not in the vaccine administered to this group
9.Other Pre-specified Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
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 to vaccine antigens was defined as a pre-vaccination and post-vaccination titer value of titer ≥ 40 (1/dil).

Time Frame Day 0 (pre-vaccination) and Day 21 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
Participants received the Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 215 188 189
Measure Type: Number
Unit of Measure: Participants
A/H1N1, Pre-vaccination (214, 186, 189) 88 71 70
A/H1N1, Post-vaccination (214, 187, 189) 193 168 169
A/H3N2, Pre-vaccination (214, 187, 189) 100 94 92
A/H3N2, Post-vaccination (214, 188, 189) 209 179 179
B/Brisbane/60/2008, Pre-vaccination (214, 0, 189) 57 NA [1]  50
B/Brisbane/60/2008, Post-vaccination (215, 0, 189) 172 NA [1]  153
B/Florida/04/2006, Pre-vaccination (0, 186, 189) NA [2]  80 67
B/Florida/04/2006, Post-vaccination (0, 187, 189) NA [2]  164 169
[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.
Time Frame Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Hide Arm/Group Description Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV) Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV) Participants received the Quadrivalent Influenza Vaccine (QIV)
All-Cause Mortality
Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/220 (0.00%)      0/190 (0.00%)      2/190 (1.05%)    
Ear and labyrinth disorders       
Vertigo positional * 1  0/220 (0.00%)  0 0/0  0 1/190 (0.53%)  1
General disorders       
Chest pain * 1  0/220 (0.00%)  0 0/0  0 1/190 (0.53%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Study Group 1 (2009-2010 Trivalent Influenza Vaccine) Study Group 2 (2008-2009 Trivalent Influenza Vaccine) Study Group 3 (Quadrivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/220 (47.73%)      84/190 (44.21%)      91/190 (47.89%)    
Gastrointestinal disorders       
Pyrexia * 1  2/30 (6.67%)  2 0/0  0 0/0  0
General disorders       
Injection site Pain  1  105/215 (48.84%)  105 82/190 (43.16%)  82 90/190 (47.37%)  90
Malaise  1  30/220 (13.64%)  30 23/190 (12.11%)  23 20/190 (10.53%)  20
Shivering  1  10/190 (5.26%)  10 6/190 (3.16%)  6 5/190 (2.63%)  5
Metabolism and nutrition disorders       
Appetite lost  1  1/15 (6.67%)  1 0/0  0 0/0  0
Musculoskeletal and connective tissue disorders       
Myalgia  1  50/220 (22.73%)  50 32/190 (16.84%)  32 45/190 (23.68%)  45
Nervous system disorders       
Headache * 1  10/190 (5.26%)  12 10/190 (5.26%)  10 5/190 (2.63%)  5
Drowsiness  1  4/15 (26.67%)  4 0/0  0 0/0  0
Headache  1  35/220 (15.91%)  35 34/190 (17.89%)  34 30/190 (15.79%)  30
Psychiatric disorders       
Crying abnormal  1  1/15 (6.67%)  1 0/0  0 0/0  0
Irritability  1  1/15 (6.67%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  3/30 (10.00%)  3 0/0  0 0/0  0
Rhinorrhoea * 1  6/30 (20.00%)  6 0/0  0 0/0  0
Skin and subcutaneous tissue disorders       
Rash * 1  2/30 (6.67%)  2 0/0  0 0/0  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 12.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00988143     History of Changes
Other Study ID Numbers: GRC43
UTN: U1111-1111-5427 ( Other Identifier: WHO )
First Submitted: October 1, 2009
First Posted: October 2, 2009
Results First Submitted: July 3, 2013
Results First Posted: December 12, 2013
Last Update Posted: December 12, 2013