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Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India

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ClinicalTrials.gov Identifier: NCT02451358
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
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: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative
Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative
Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative
Enrollment 400
Recruitment Details Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.
Pre-assignment Details A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0. Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Period Title: Overall Study
Started 100 100 100 100
Vaccinated at Day 0 100 100 100 100
Vaccinated at Day 28 99 98 0 [1] 0 [1]
Completed 99 98 99 100
Not Completed 1 2 1 0
Reason Not Completed
Withdrawal by Subject             1             1             0             0
Protocol Violation             0             1             1             0
[1]
Participants aged 9 years and older received only 1 dose of Quadrivalent Influenza Vaccine.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years Total
Hide Arm/Group Description Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0. Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 99 98 99 100 396
Hide Baseline Analysis Population Description
Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 98 participants 99 participants 100 participants 396 participants
1.0  (0.8) 4.9  (1.5) 11.7  (2.2) 48.5  (18.8) 16.6  (21.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 98 participants 99 participants 100 participants 396 participants
Female
45
  45.5%
60
  61.2%
50
  50.5%
34
  34.0%
189
  47.7%
Male
54
  54.5%
38
  38.8%
49
  49.5%
66
  66.0%
207
  52.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 99 participants 98 participants 99 participants 100 participants 396 participants
99 98 99 100 396
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Hide Description Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Time Frame Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description:
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Overall Number of Participants Analyzed 99 98 99 100
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Pre-Vaccination: A/H1N1 Number Analyzed 99 participants 98 participants 99 participants 99 participants
14.4
(9.83 to 21.1)
84.1
(53.6 to 132)
107
(83.4 to 138)
44.3
(31.8 to 61.6)
Pre-Vaccination: A/H3N2 Number Analyzed 99 participants 98 participants 99 participants 100 participants
44.4
(26.6 to 74.2)
416
(311 to 555)
204
(150 to 277)
20.8
(15.8 to 27.3)
Pre-Vaccination: B Victoria Number Analyzed 99 participants 97 participants 99 participants 98 participants
21.5
(14.0 to 32.8)
37.5
(23.8 to 59.1)
54.1
(41.4 to 70.6)
41.9
(31.9 to 55.0)
Pre-Vaccination: B Yamagata Number Analyzed 99 participants 98 participants 99 participants 99 participants
12.0
(8.82 to 16.3)
81.1
(53.9 to 122)
91.7
(67.2 to 125)
107
(79.5 to 144)
Post-Vaccination: A/H1N1 Number Analyzed 99 participants 98 participants 99 participants 99 participants
723
(527 to 993)
1895
(1550 to 2318)
1641
(1398 to 1927)
1232
(969 to 1565)
Post-Vaccination: A/H3N2 Number Analyzed 99 participants 98 participants 99 participants 100 participants
1016
(697 to 1482)
3458
(3011 to 3971)
2379
(1994 to 2838)
980
(736 to 1306)
Post-Vaccination: B Victoria Number Analyzed 99 participants 98 participants 99 participants 100 participants
658
(441 to 982)
2222
(1820 to 2713)
2061
(1622 to 2617)
1150
(913 to 1447)
Post-Vaccination: B Yamagata Number Analyzed 99 participants 98 participants 99 participants 98 participants
951
(675 to 1338)
3582
(3054 to 4201)
2273
(1750 to 2951)
1836
(1413 to 2385)
2.Primary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer >=40 (1/dilution[dil]) at pre-vaccination and at post-final vaccination.
Time Frame Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description:
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Overall Number of Participants Analyzed 99 98 99 100
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-Vaccination: A/H1N1 Number Analyzed 99 participants 98 participants 99 participants 99 participants
23
  23.2%
62
  63.3%
86
  86.9%
60
  60.6%
Pre-Vaccination: A/H3N2 Number Analyzed 99 participants 98 participants 99 participants 100 participants
40
  40.4%
94
  95.9%
85
  85.9%
34
  34.0%
Pre-Vaccination: B Victoria Number Analyzed 99 participants 97 participants 99 participants 98 participants
30
  30.3%
47
  48.5%
63
  63.6%
53
  54.1%
Pre-Vaccination: B Yamagata Number Analyzed 99 participants 98 participants 99 participants 99 participants
18
  18.2%
65
  66.3%
74
  74.7%
83
  83.8%
Post-Vaccination: A/H1N1 Number Analyzed 99 participants 98 participants 99 participants 99 participants
93
  93.9%
98
 100.0%
99
 100.0%
99
 100.0%
Post-Vaccination: A/H3N2 Number Analyzed 99 participants 98 participants 99 participants 100 participants
96
  97.0%
98
 100.0%
99
 100.0%
96
  96.0%
Post-Vaccination: B Victoria Number Analyzed 99 participants 98 participants 99 participants 100 participants
88
  88.9%
98
 100.0%
98
  99.0%
99
  99.0%
Post-Vaccination: B Yamagata Number Analyzed 99 participants 98 participants 99 participants 98 participants
93
  93.9%
98
 100.0%
98
  99.0%
97
  99.0%
3.Primary Outcome
Title Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <10 (1/dil) and post-vaccination titer >=40 (1/dil), and Significant increase was defined as pre-vaccination titer >=10 (1/dil) and >= 4-fold increase of post-vaccination titer.
Time Frame 28 days post-final vaccination (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description:
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Overall Number of Participants Analyzed 99 98 99 100
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1 Number Analyzed 99 participants 98 participants 99 participants 98 participants
86
  86.9%
87
  88.8%
84
  84.8%
90
  91.8%
A/H3N2 Number Analyzed 99 participants 98 participants 99 participants 100 participants
85
  85.9%
77
  78.6%
71
  71.7%
90
  90.0%
B Victoria Number Analyzed 99 participants 97 participants 99 participants 98 participants
84
  84.8%
87
  89.7%
95
  96.0%
92
  93.9%
B Yamagata Number Analyzed 99 participants 98 participants 99 participants 97 participants
91
  91.9%
91
  92.9%
86
  86.9%
86
  88.7%
4.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Hide Description
  1. Solicited injection site reactions:

    • Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm)
    • Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years])
  2. Solicited systemic reactions:

    • Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable)
    • Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)
Time Frame Within 7 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, ‘Number Analyzed’ = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description:
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
Overall Number of Participants Analyzed 100 100 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site Pain / Tenderness Number Analyzed 100 participants 100 participants 100 participants 100 participants
12
  12.0%
40
  40.0%
35
  35.0%
24
  24.0%
Grade 3: Injection site Pain / Tenderness Number Analyzed 100 participants 100 participants 100 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Injection site Erythema Number Analyzed 100 participants 100 participants 100 participants 100 participants
1
   1.0%
3
   3.0%
4
   4.0%
0
   0.0%
Grade 3 Injection site Erythema Number Analyzed 100 participants 100 participants 100 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Injection site Swelling Number Analyzed 100 participants 100 participants 100 participants 100 participants
2
   2.0%
3
   3.0%
4
   4.0%
0
   0.0%
Grade 3 Injection site Swelling Number Analyzed 100 participants 100 participants 100 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fever Number Analyzed 100 participants 98 participants 99 participants 100 participants
9
   9.0%
8
   8.2%
2
   2.0%
0
   0.0%
Grade 3 Fever Number Analyzed 100 participants 98 participants 99 participants 100 participants
0
   0.0%
2
   2.0%
0
   0.0%
0
   0.0%
Vomiting Number Analyzed 71 participants 0 participants 0 participants 0 participants
2
   2.8%
Grade 3 Vomiting Number Analyzed 71 participants 0 participants 0 participants 0 participants
2
   2.8%
Crying abnormal Number Analyzed 71 participants 0 participants 0 participants 0 participants
1
   1.4%
Grade 3 Crying abnormal Number Analyzed 71 participants 0 participants 0 participants 0 participants
0
   0.0%
Drowsiness Number Analyzed 71 participants 0 participants 0 participants 0 participants
1
   1.4%
Grade 3 Drowsiness Number Analyzed 71 participants 0 participants 0 participants 0 participants
0
   0.0%
Appetite lost Number Analyzed 71 participants 0 participants 0 participants 0 participants
3
   4.2%
Grade 3 Appetite lost Number Analyzed 71 participants 0 participants 0 participants 0 participants
0
   0.0%
Irritability Number Analyzed 71 participants 0 participants 0 participants 0 participants
5
   7.0%
Grade 3 Irritability Number Analyzed 71 participants 0 participants 0 participants 0 participants
0
   0.0%
0
Headache Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
4
   4.0%
6
   6.0%
1
   1.0%
Grade 3 Headache Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
Malaise Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
4
   4.0%
7
   7.0%
1
   1.0%
Grade 3 Malaise Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia Number Analyzed 29 participants 100 participants 100 participants 100 participants
1
   3.4%
9
   9.0%
16
  16.0%
3
   3.0%
Grade 3 Myalgia Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Shivering Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
2
   2.0%
0
   0.0%
1
   1.0%
Grade 3 Shivering Number Analyzed 29 participants 100 participants 100 participants 100 participants
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
Time Frame Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
Adverse Event Reporting Description A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
 
Arm/Group Title Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Hide Arm/Group Description Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28. Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0. Participants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
All-Cause Mortality
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%)   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years Quadrivalent Influenza Vaccine Group 4: >=18 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/100 (29.00%)   50/100 (50.00%)   44/100 (44.00%)   24/100 (24.00%) 
General disorders         
Injection site pain  1  12/100 (12.00%)  40/100 (40.00%)  35/100 (35.00%)  24/100 (24.00%) 
Malaise  1  0/100 (0.00%)  4/100 (4.00%)  7/100 (7.00%)  1/100 (1.00%) 
Pyrexia  1  14/100 (14.00%)  8/100 (8.00%)  2/100 (2.00%)  0/100 (0.00%) 
Infections and infestations         
Upper respiratory tract infection  1  5/100 (5.00%)  3/100 (3.00%)  0/100 (0.00%)  0/100 (0.00%) 
Musculoskeletal and connective tissue disorders         
Myalgia  1  1/100 (1.00%)  9/100 (9.00%)  16/100 (16.00%)  3/100 (3.00%) 
Nervous system disorders         
Headache  1  0/100 (0.00%)  4/100 (4.00%)  6/100 (6.00%)  1/100 (1.00%) 
Psychiatric disorders         
Irritability  1  6/100 (6.00%)  0/100 (0.00%)  0/100 (0.00%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/100 (3.00%)  5/100 (5.00%)  0/100 (0.00%)  0/100 (0.00%) 
1
Term from vocabulary, MedDra 18.0
Indicates events were collected by systematic assessment
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.
Phone: 800-633-1610 ext 1#
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02451358     History of Changes
Other Study ID Numbers: QIV06
U1111-1143-8370 ( Other Identifier: WHO )
CTRI/2015/05/005770 ( Other Identifier: CTR-India )
First Submitted: May 14, 2015
First Posted: May 22, 2015
Results First Submitted: January 29, 2018
Results First Posted: March 1, 2018
Last Update Posted: March 1, 2018