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Study of Quadrivalent Influenza Vaccine Among Children

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ClinicalTrials.gov Identifier: NCT01240746
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : January 14, 2014
Last Update Posted : July 14, 2015
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: Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative
Biological: Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative
Biological: Quadrivalent Influenza Vaccine, No Preservative
Enrollment 4363
Recruitment Details The study participants were enrolled from 11 November 2010 to 20 June 2011 in 69 clinical centers in the US
Pre-assignment Details A total of 4363 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 (2010-2011 Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen. Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Period Title: Overall Study
Started 736 725 2902
Completed 677 677 2659
Not Completed 59 48 243
Reason Not Completed
Adverse Event             2             0             10
Lost to Follow-up             23             20             102
Protocol Violation             24             15             72
Withdrawal by Subject             10             13             59
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine) Total
Hide Arm/Group Description Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen Participants received the Investigational Quadrivalent Influenza Vaccine (QIV) Total of all reporting groups
Overall Number of Baseline Participants 736 725 2902 4363
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 736 participants 725 participants 2902 participants 4363 participants
<=18 years
736
 100.0%
725
 100.0%
2902
 100.0%
4363
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 736 participants 725 participants 2902 participants 4363 participants
49.6  (29.0) 49.6  (28.7) 49.8  (29.7) 49.8  (29.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 736 participants 725 participants 2902 participants 4363 participants
Female
367
  49.9%
359
  49.5%
1427
  49.2%
2153
  49.3%
Male
369
  50.1%
366
  50.5%
1475
  50.8%
2210
  50.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 736 participants 725 participants 2902 participants 4363 participants
736 725 2902 4363
1.Primary Outcome
Title Geometric Mean Titers Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All 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 Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers (GMT) to influenza vaccine A antigens were determined in randomized and vaccinated participants, per-protocol population. The GMT data for antigen A/Victoria/210/2009 and A/California/07/2009 were pooled for participants vaccinated with either 2010-2011 TIV or the investigational TIV. Data presented in column for Group 1.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 1461 0 2339
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/California/07/2009 (A/H1N1) [N = 1461, 0, 2339]
1096
(1008 to 1192)
1124
(1060 to 1192)
A/Victoria/210/2009 (A/H3N2) [N = 1461, 0, 2339
828
(774 to 887)
822
(783 to 862)
2.Primary Outcome
Title Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All 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 Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to 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 antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
B/Brisbane/60/2008 (581, 0, 2238)
64.3
(58.3 to 70.9)
NA [1] 
(NA to NA)
86.1
(81.8 to 90.6)
B/Florida/04/2006 (0, 598, 2338)
NA [2] 
(NA to NA)
58.3
(52.6 to 64.7)
61.5
(58.6 to 64.7)
[1]
B/Brisbane/60/2008 antigen was not in the influenza vaccine administered to this group.
[2]
B/Florida/04/2006 antigen was not in the influenza vaccine administered to this group.
3.Primary Outcome
Title Geometric Mean Titers Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All 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 Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to influenza vaccine B antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
B/Brisbane/60/2008 (0, 599, 2338)
NA [1] 
(NA to NA)
19.5
(17.4 to 21.8)
86.1
(81.8 to 90.6)
B/Florida/04/2006 (581, 0, 2338)
16.3
(14.8 to 17.9)
NA [2] 
(NA to NA)
61.5
(58.6 to 64.7)
[1]
B/Florida/04/2006 antigen was not in the influenza vaccine administered to this group.
[2]
B/Brisbane/60/2008 antigen was not in the influenza vaccine administered to this group.
4.Primary Outcome
Title Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
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 28 post final 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. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 225 245 949
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1, Pre-vaccination (224, 245, 943)
25.6
(19.4 to 33.7)
31.3
(23.8 to 41.1)
25.7
(22.4 to 29.5)
A/H1N1, Post-vaccination (224, 243, 947)
797
(664 to 957)
645
(530 to 784)
747
(680 to 821)
A/H3N2, Pre-vaccination (224, 245, 945)
9.52
(7.90 to 11.5)
10.1
(8.26 to 12.3)
9.19
(8.42 to 10.0)
A/H3N2, Post-vaccination (224, 243, 944)
558
(483 to 646)
583
(507 to 671)
526
(492 to 562)
B/Brisbane, Pre-vaccination (225, 245, 947)
6.56
(5.92 to 7.27)
6.62
(6.00 to 7.30)
6.41
(6.10 to 6.73)
B/Brisbane, Post-vaccination (225, 245, 948)
54.7
(47.2 to 63.4)
12.0
(10.3 to 13.9)
72.8
(67.3 to 78.7)
B/Florida, Pre-vaccination (225, 245, 946)
5.33
(5.10 to 5.56)
5.26
(5.09 to 5.44)
5.34
(5.23 to 5.46)
B/Florida, Post-vaccination (225, 245, 948)
8.56
(7.68 to 9.54)
32.9
(28.7 to 37.6)
36.2
(33.7 to 38.8)
5.Primary Outcome
Title Geometric Mean Titers Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
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 28 post-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. Data presented for participants aged 3 years to less than 9 Years with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 357 354 1390
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1, Pre-vaccination (357, 354, 1390)
53.5
(43.9 to 65.2)
54.4
(44.4 to 66.8)
54.9
(49.6 to 60.7)
A/H1N1, Post-vaccination (357, 354, 1390)
1565
(1355 to 1807)
1348
(1166 to 1559)
1484
(1380 to 1595)
A/H3N2, Pre-vaccination (355, 353, 1389)
70.6
(57.3 to 87.0)
64.1
(51.9 to 79.2)
63.9
(57.6 to 70.8)
A/H3N2, Post-vaccination (356, 353, 1390)
924
(816 to 1046)
1214
(1078 to 1367)
1112
(1046 to 1183)
B/Brisbane, Pre-vaccination (357, 354, 1390)
10.1
(9.05 to 11.2)
10.6
(9.52 to 11.9)
9.73
(9.23 to 10.3)
B/Brisbane, Post-vaccination (356, 354, 1390)
71.2
(62.6 to 81.1)
27.3
(23.4 to 31.8)
96.6
(90.3 to 103)
B/Florida, Pre-vaccination (357, 353, 1390)
9.09
(8.26 to 10.0)
9.84
(8.91 to 10.9)
9.34
(8.89 to 9.82)
B/Florida, Post-vaccination (356, 353, 1390)
24.4
(21.6 to 27.5)
86.9
(76.1 to 99.2)
88.5
(83.1 to 94.1)
6.Other Pre-specified Outcome
Title Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines With Corresponding B Strain in All 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.

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

Time Frame Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respect to influenza vaccine B antigens were determined in randomized and vaccinated participants, per-protocol population
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Measure Type: Number
Unit of Measure: Participants
B/Brisbane/60/2008 (581, 0, 2336) 355 NA [1]  1677
B/Florida/04/2006 (0, 598, 2335) NA [2]  383 1543
[1]
B/Brisbane/60/2008 antigen was not in the influenza vaccine administered to this group.
[2]
B/Florida/04/2006 antigen was not in the influenza vaccine administered to this group.
7.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All 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.

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

Time Frame Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza vaccine antigens was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Pre-vaccination (581, 599, 2333) 291 305 1159
A/H1N1 Post-vaccination (581, 597, 2337) 573 585 2305
A/H3N2 Pre-vaccination (579, 596, 2334) 248 241 946
A/H3N2 Post-vaccination (580, 599, 2334) 575 593 2326
B/Brisbane Pre-vaccination 582, 599, 2337) 64 79 261
B/Brisbane Post-vaccination (581, 599, 2338) 418 202 1838
B/Florida Pre-vaccination (582, 598, 2336) 51 55 199
B/Florida Post-vaccination (581, 598, 2338) 169 416 1674
8.Other Pre-specified Outcome
Title Seroconversion Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All 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.

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 a four-fold increase in post-vaccination.

Time Frame Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respect to vaccine antigens (cross-reactive antibody) were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (580, 597, 2331) 541 535 2135
A/H3N2 (578, 596, 2329) 477 512 2050
B/Brisbane (581, 599, 2336) 355 120 1677
B/Florida (581, 598, 2335) 104 383 1543
9.Other Pre-specified Outcome
Title Seroconversion Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines Without Corresponding B Strain in All 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.

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 a four-fold increase in post-vaccination.

Time Frame Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion with respect to influenza vaccine B antigens (cross-reactive antibody) was determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the B antigens.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 582 599 2339
Measure Type: Number
Unit of Measure: Participants
B/Brisbane/60/2008 (0, 599, 2336) NA [1]  120 1677
B/Florida/04/2006 (581, 0, 2335) 104 NA [2]  1543
[1]
B/Florida/04/2006 antigen was not in the influenza vaccine administered to this group
[2]
B/Brisbane/60/2008 antigen was not in the influenza vaccine administered to this group
10.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 6 Months to Less Than 36 Months.
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 ≥ 40 (l/dil).

Time Frame Day 28 post final vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 6 months to less than 36 months with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 225 245 949
Measure Type: Number
Unit of Measure: Participants
H1N1 Pre-vaccination (224, 245, 943) 80 100 327
H1N1 Post-vaccination (223, 243, 941) 220 237 925
H3N2 Pre-vaccination (224, 245, 945) 26 29 104
H3N2 Post-vaccination (223, 243, 944) 221 242 943
B/Brisbane Pre-vaccination (225, 245, 947) 14 18 61
B/Brisbane Post-vaccination (225, 245, 948) 155 55 716
B/Florida Pre-vaccination (225, 245, 946) 4 1 10
B/Florida Post-vaccination (225, 245, 948) 19 135 550
11.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in Participants Aged 3 Years to Less Than 9 Years.
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 ≥ 40 (l/dil).

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants aged 3 years to less than 9 years with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 357 354 1390
Measure Type: Number
Unit of Measure: Participants
H1N1 Pre-vaccination (357, 354, 1390) 211 205 832
H1N1 Post-vaccination (357, 354, 1390) 353 348 1380
H3N2 Pre-vaccination (355, 353, 1389) 222 212 842
H3N2 Post-vaccination (356, 353, 1390) 354 351 1383
B/Brisbane Pre-vaccination (357, 354, 1390) 50 61 200
B/Brisbane Post-vaccination (356, 354, 1390) 263 147 1122
B/Florida Pre-vaccination (357, 353, 1390) 47 54 189
B/Florida Post-vaccination (356, 353, 1390) 150 281 1124
12.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With One Dose of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All 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.

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

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 114 141 510
Measure Type: Number
Unit of Measure: Participants
H1N1 Pre-vaccination (114, 141, 510) 62 89 289
H1N1 Post-vaccination (114, 141, 510) 111 139 498
H3N2 Pre-vaccination (112, 141, 510) 64 75 259
H3N2 Post-vaccination (112, 141, 510) 110 138 504
B/Brisbane Pre-vaccination (114, 141, 510) 15 25 66
B/Brisbane Post-vaccination (113, 141, 510) 72 55 341
B/Florida Pre-vaccination (114, 141, 510) 18 20 58
B/Florida Post-vaccination (113, 141, 510) 46 98 350
13.Other Pre-specified Outcome
Title Seroprotection Against Influenza Vaccine Antigens After Vaccination With Two Doses of Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines in All Participants
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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 ≥ 40 (l/dil).

Time Frame Day 28 post final vaccination
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Hide Analysis Population Description
Seroprotection against influenza vaccine antigens were determined in randomized and vaccinated participants, per-protocol population. Data presented for participants with valid serology results for the particular antigen.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
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Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 468 458 1829
Measure Type: Number
Unit of Measure: Participants
H1N1 Pre-vaccination (467, 458, 1823) 229 216 870
H1N1 Post-vaccination (467, 456, 1827) 462 446 1807
H3N2 Pre-vaccination (467, 457, 1824) 184 166 687
H3N2 Post-vaccination (467, 455, 1824) 465 455 1822
B/Brisbane Pre-vaccination (468, 458, 1827) 49 54 195
B/Brisbane Post-vaccination (468, 458, 1828) 346 147 1497
B/Florida Pre-vaccination (468, 457, 1826) 33 35 141
B/Florida Post-vaccination (468, 457, 1828) 123 318 1324
14.Other Pre-specified Outcome
Title Number of Participants Aged 6 Months to <36 Months Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines.
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Solicited injection site reactions (Age 6-23 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.

Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling ≥ 50 mm; Fever: >103.1°F; Vomiting: ≥6 episodes/24 hours; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals or most feeds/meals; Irritability: inconsolable.

Solicited Injection site reactions (Age 24 Months to < 36 months): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

Grade 3: Pain: Incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity.

Time Frame Day 0 up to Day 7 post-vaccination
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Hide Analysis Population Description
Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 6 months to <36 months with available data for the relevant endpoint.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 310 308 1223
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (130, 149, 521) 68 75 297
Grade 3 Injection site Pain (130, 149, 521) 1 4 5
Injection site Tenderness (159, 145, 628) 77 72 340
Grade 3 Injection site Tenderness (159, 145, 628) 3 0 12
Injection site Erythema (289, 294, 1150) 95 98 429
Grade 3 Injection site Erythema (289, 294, 1150) 0 0 2
Injection site Swelling (289, 294, 1150) 57 51 248
Grade 3 Injection site Swelling (289, 294, 1150) 0 0 2
Fever (288, 293, 1148) 46 38 164
Grade 3 Fever (288, 293, 1148) 5 6 24
Vomiting (159, 144, 628) 18 20 93
Grade 3 Vomiting (159, 144, 628) 1 0 6
Crying abnormal (159, 144, 628) 58 43 259
Grade 3 Crying abnormal (159, 144, 628) 3 3 21
Drowsiness (159, 144, 628) 51 46 237
Grade 3 Drowsiness (159, 144, 628) 1 1 8
Headache (128, 148, 517) 12 18 46
Grade 3 Headache (128, 148, 517) 0 0 3
Appetite lost (159, 144, 628) 53 36 203
Grade 3 Appetite lost (159, 144, 628) 3 1 11
Malaise (128, 148, 517) 45 48 197
Grade Malaise (128, 148, 517) 6 10 24
Myalgia (128, 148, 517) 34 37 138
Grade 3 Myalgia (128, 148, 517) 2 4 10
Irritability (159, 144, 628) 84 77 339
Grade 3 Irritability (159, 144, 628) 5 4 20
15.Other Pre-specified Outcome
Title Number of Participants Aged 3 Years to <9 Years Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccines
Hide Description Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature); Headache, Malaise and Myalgia Grade 3 Pain: incapacitating, unable to perform usual activities; Redness and Swelling: ≥ 50 mm; Fever: ≥ 102.1°F; Headache, Malaise and Myalgia: Significant, prevents daily activity, respectively.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety profile were assessed in all randomized and vaccinated participants, safety population. Values presented for participants aged 3 years to <9 years with available data for the relevant endpoint.
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description:
Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
Overall Number of Participants Analyzed 424 413 1669
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (410, 398, 1592) 265 254 1061
Grade 3 Injection site Pain (410, 398, 1592) 8 11 33
Injection site Erythema (410, 398, 1592) 151 140 543
Grade 3 Injection site Erythema (410, 398, 1592) 5 7 29
Injection site Swelling (410, 398, 1592) 104 103 395
Grade 3 Injection site Swelling (410, 398, 1592) 5 7 22
Fever (409, 396, 1591) 29 30 112
Grade 3 Fever (409, 396, 1591) 5 3 34
Headache (411, 398, 1593) 87 97 368
Grade 3 Headache (411, 398, 1593) 11 8 35
Malaise (411, 398, 1593) 135 133 508
Grade 3 Malaise (411, 398, 1593) 23 20 87
Myalgia (411, 398, 1593) 140 153 615
Grade 3 Myalgia (411, 398, 1593) 11 11 52
Time Frame Adverse events data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
Adverse Event Reporting Description Data are presented for participants with available safety data for the relevant endpoints.
 
Arm/Group Title Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Hide Arm/Group Description Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
All-Cause Mortality
Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/734 (0.95%)      14/721 (1.94%)      41/2892 (1.42%)    
Cardiac disorders       
Bradycardia * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
General disorders       
Drowning * 1  1/225 (0.44%)  1 0/721 (0.00%)  0 0/2892 (0.00%)  0
Pyrexia * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Infections and infestations       
Appendicitis * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Croup infectious * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Gastroenteritis * 1  0/734 (0.00%)  0 2/721 (0.28%)  2 2/2892 (0.07%)  2
Gastroenteritis viral * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Mycoplasma infection * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Otitis media * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Periorbital cellulitis * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Peritonsillar abscess * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Pneumonia * 1  1/734 (0.14%)  1 1/721 (0.14%)  1 1/2892 (0.03%)  1
Respiratory syncytial vrus bronchiolitis * 1  1/734 (0.14%)  1 1/721 (0.14%)  1 2/2892 (0.07%)  2
Respiratory syncytial vrus infection * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Staphylococcal abscess * 1  1/734 (0.14%)  1 0/721 (0.00%)  0 0/2892 (0.00%)  0
Staphylococcal infection * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Viral infection * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Viral upper respiratory tract infection * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 1/2892 (0.03%)  1
Injury, poisoning and procedural complications       
Accidental exposure * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  10
Femur fracture * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 2/2892 (0.07%)  2
Metabolism and nutrition disorders       
Dehydration * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Hypovolaemia * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Astrocytoma, low grade * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Nervous system disorders       
Autism * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Febrile convulsion * 1  2/734 (0.27%)  2 3/721 (0.42%)  3 8/2892 (0.28%)  8
Seizure anoxic * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Psychiatric disorders       
Affective disorder * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adenoidal hypertrophy * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 0/2892 (0.00%)  0
Asthma * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 8/2892 (0.28%)  8
Bronchial hrperreactivity * 1  0/734 (0.00%)  0 1/721 (0.14%)  1 1/2892 (0.03%)  1
Respiratory arrest * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 1/2892 (0.03%)  1
Status asthmaticus * 1  1/734 (0.14%)  1 0/721 (0.00%)  0 0/2892 (0.00%)  0
Vascular disorders       
Kawasaki's disease * 1  0/734 (0.00%)  0 0/721 (0.00%)  0 3/2892 (0.10%)  3
*
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%
Study Group 1 (Trivalent Influenza Vaccine) Study Group 2 (Investigational Trivalent Influenza Vaccine) Study Group 3 (Investigational Quadrivalent Influenza Vaccine)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   333/734 (45.37%)      329/721 (45.63%)      1358/2892 (46.96%)    
Gastrointestinal disorders       
Vomiting  1  18/159 (11.32%)  18 20/144 (13.89%)  20 93/628 (14.81%)  93
Diarrhoea * 1  42/734 (5.72%)  51 38/721 (5.27%)  48 135/2892 (4.67%)  150
Vomiting * 1  46/734 (6.27%)  52 55/721 (7.63%)  61 193/2892 (6.67%)  209
General disorders       
Injection site pain * 1  333/540 (61.67%)  333 329/547 (60.15%)  329 1358/2113 (64.27%)  1358
Injection site Swelling * 1  161/734 (21.93%)  162 154/692 (22.25%)  154 643/2742 (23.45%)  643
Malaise  1  180/539 (33.40%)  180 181/546 (33.15%)  181 705/2110 (33.41%)  705
Injection site tenderness  1  77/159 (48.43%)  77 72/145 (49.66%)  72 340/628 (54.14%)  340
Injection site erythema  1  246/699 (35.19%)  246 238/692 (34.39%)  238 972/2742 (35.45%)  972
Fever  1  75/695 (10.79%)  75 68/689 (9.87%)  68 276/2739 (10.08%)  276
Pyrexia * 1  44/734 (5.99%)  49 65/721 (9.02%)  75 188/2892 (6.50%)  213
Infections and infestations       
Upper respiratory tract infection * 1  43/734 (5.86%)  51 47/721 (6.52%)  50 184/2892 (6.36%)  203
Metabolism and nutrition disorders       
Appetite lost  1  53/159 (33.33%)  53 36/144 (25.00%)  36 203/628 (32.32%)  203
Musculoskeletal and connective tissue disorders       
Myalgia  1  174/539 (32.28%)  174 190/546 (34.80%)  190 753/2110 (35.69%)  753
Nervous system disorders       
Headache  1  99/539 (18.37%)  99 115/546 (21.06%)  115 414/2110 (19.62%)  414
Drowsiness  1  51/159 (32.08%)  51 46/144 (31.94%)  46 237/628 (37.74%)  237
Psychiatric disorders       
Crying abnormal  1  58/159 (36.48%)  58 43/144 (29.86%)  43 259/628 (41.24%)  259
Irritability  1  84/159 (52.83%)  84 77/144 (53.47%)  77 339/628 (53.98%)  339
Respiratory, thoracic and mediastinal disorders       
Cough * 1  95/734 (12.94%)  107 89/721 (12.34%)  100 341/2892 (11.79%)  381
Rhinorrhoea * 1  37/734 (5.04%)  38 34/721 (4.72%)  39 167/2892 (5.77%)  189
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: NCT01240746     History of Changes
Other Study ID Numbers: QIV04
UTN: U1111-1114-3713 ( Other Identifier: WHO )
First Submitted: November 11, 2010
First Posted: November 15, 2010
Results First Submitted: July 3, 2013
Results First Posted: January 14, 2014
Last Update Posted: July 14, 2015