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Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years

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ClinicalTrials.gov Identifier: NCT01712984
Recruitment Status : Completed
First Posted : October 24, 2012
Results First Posted : February 10, 2014
Last Update Posted : May 7, 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: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
Biological: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
Enrollment 3360
Recruitment Details The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.
Pre-assignment Details A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Period Title: Overall Study
Started 1672 837 846
Completed 1656 821 836
Not Completed 16 16 10
Reason Not Completed
Adverse Event             0             0             1
Protocol Violation             2             0             1
Lost to Follow-up             8             10             1
Withdrawal by Subject             6             6             7
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group Total
Hide Arm/Group Description Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2) Total of all reporting groups
Overall Number of Baseline Participants 1672 837 846 3355
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1672 participants 837 participants 846 participants 3355 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1672
 100.0%
837
 100.0%
846
 100.0%
3355
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1672 participants 837 participants 846 participants 3355 participants
41.6  (13.2) 41.2  (13.5) 41.9  (13.3) 41.6  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1672 participants 837 participants 846 participants 3355 participants
Female
1022
  61.1%
505
  60.3%
528
  62.4%
2055
  61.3%
Male
650
  38.9%
332
  39.7%
318
  37.6%
1300
  38.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1672 participants 837 participants 846 participants 3355 participants
1672 837 846 3355
1.Primary Outcome
Title Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Hide Description Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description:
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Overall Number of Participants Analyzed 1041 539 533
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 (N=1041, 539, 533)
589
(546 to 636)
728
(653 to 811)
635
(568 to 709)
A/H3N2 (N=1041, 538, 533)
368
(342 to 397)
413
(369 to 462)
447
(401 to 498)
B/Texas/6/2011 (B1; N=1041, 539, 533)
105
(99.1 to 112)
93.5
(85.9 to 102)
54.0
(49.3 to 59.2)
B/Brisbane/60/2008 (B2; N=1041, 538, 533)
136
(128 to 145)
66.7
(61.0 to 72.9)
130
(118 to 143)
2.Primary Outcome
Title Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Hide Description Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description:
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Overall Number of Participants Analyzed 1041 539 533
Measure Type: Number
Unit of Measure: Participants
A/H1N1 (N=1041, 539, 533) 600 333 314
A/H3N2 (N=1040, 538, 533) 608 326 314
B/Texas/6/2011 (B1; N=1041, 539, 533) 580 253 131
B/Brisbane/60/2008 (B2; N=1041, 538, 533) 525 119 235
3.Secondary Outcome
Title Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Hide Description Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description:
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Overall Number of Participants Analyzed 1041 539 533
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
A/H1N1 Day 0 (N=1041, 539, 533)
66.3
(59.5 to 73.8)
65.2
(56.0 to 76.0)
66.2
(56.9 to 77.0)
A/H1N1 Day 28 (N=1041, 539, 533)
589
(546 to 636)
728
(653 to 811)
635
(568 to 709)
A/H3N2 Day 0 (N=1040, 539, 533)
52.3
(47.5 to 57.5)
56.5
(49.2 to 64.9)
55.7
(48.4 to 64.0)
A/H3N2 Day 28 (N=1041, 538, 533)
368
(342 to 397)
413
(369 to 462)
447
(401 to 498)
B1 Day 0 (N=1041, 539, 533)
21.7
(20.5 to 23.1)
24.7
(22.7 to 27.0)
22.2
(20.4 to 24.2)
B1 Day 28 (N=1041, 539, 533)
105
(99.1 to 112)
93.5
(85.9 to 102)
54.0
(49.3 to 59.2)
B2 Day 0 (N=1041, 539, 533)
26.8
(25.0 to 28.8)
29.7
(26.9 to 32.8)
25.4
(23.0 to 28.1)
B2 Day 28 (N=1041, 538, 533)
136
(128 to 145)
66.7
(61.0 to 72.9)
130
(118 to 143)
4.Secondary Outcome
Title Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Hide Description Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description:
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Overall Number of Participants Analyzed 1041 539 533
Measure Type: Number
Unit of Measure: Participants
A/H1N1 Day 0 (N=1041, 539, 533) 672 334 353
A/H1N1 Day 28 (N=1041, 539, 533) 1014 537 524
A/H3N2 Day 0 (N=1040, 539, 533) 655 340 332
A/H3N2 Day 28 (N=1041, 538, 533) 1008 526 519
B1 Day 0 (N=1041, 539, 533) 335 210 172
B1 Day 28 (N=1041, 539, 533) 923 464 351
B2 Day 0 (N=1041, 539, 533) 467 262 224
B2 Day 28 (N=1041, 538, 533) 976 403 477
5.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
Hide Description Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description:
Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
Overall Number of Participants Analyzed 1672 837 846
Measure Type: Number
Unit of Measure: Participants
Injection site Pain (N=1656,820,838) 883 395 420
Grade 3 Injection site Pain (N=1656,820,838) 24 10 12
Injection site Erythema (N=1656,820,838) 607 279 269
Grade 3 Injection site Erythema (N=1656,820,838) 7 1 3
Injection site Swelling (N=1655,820,838) 322 121 123
Grade 3 Injection site Swelling (N=1655,820,838) 2 0 0
Injection site Induration (N=1656,820,837) 282 111 94
Grade 3 Injection site Induration (N=1656,820,837) 1 0 0
Injection site Ecchymosis (N=1656,820,838) 43 15 15
Grade 3 Injection site Ecchymosis (N=1656,820,838) 0 0 0
Fever (N=1649,819,836) 13 6 4
Grade 3 Fever (N=1649,819,836) 3 1 0
Headache (N=1656,820,838) 548 257 278
Grade 3 Headache (N=1656,820,838) 53 20 15
Malaise (N=1656,820,838) 459 216 255
Grade 3 Malaise (N=1656,820,838) 49 15 21
Myalgia (N=1656,820,838) 564 238 261
Grade 3 Myalgia (N=1656,820,838) 43 12 21
Shivering (N=1656,820,838) 200 85 94
Grade 3 Shivering (N=1656,820,838) 24 5 13
Injection site Pruritus (N=1656,820,838) 862 372 374
Grade 3 Injection site Pruritus (N=1656,820,838) 47 15 19
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Hide Arm/Group Description Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1) Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
All-Cause Mortality
QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/1672 (1.20%)      14/837 (1.67%)      11/846 (1.30%)    
Cardiac disorders       
Acute myocardial infarction * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Aortic valve disease * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Atrial fibrillation * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Cardiac tamponade * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Ear and labyrinth disorders       
Vertigo * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Gastrointestinal disorders       
Colitis * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
General disorders       
Chest pain * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Dysplasia * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Hepatobiliary disorders       
Bile duct stone * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Cholelithiasis * 1  1/1672 (0.06%)  1 1/837 (0.12%)  1 0/846 (0.00%)  0
Immune system disorders       
Sarcoidosis * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Infections and infestations       
Clostridium difficile colitis * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Osteomyelitis * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Pneumonia * 1  2/1672 (0.12%)  2 0/837 (0.00%)  0 1/846 (0.12%)  1
Pneumonia primary atypical * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Injury, poisoning and procedural complications       
Alcohol poisoning * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Concussion * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Hip fracture * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Joint injury * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Laceration * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Lower limb fracture * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Neck injury * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Seroma * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Hypovolaemia * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Musculoskeletal chest pain * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Osteoarthritis * 1  1/1672 (0.06%)  1 1/837 (0.12%)  1 1/846 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Lung neoplasm malignant * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Headache * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Hemiplegic migraine * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Syncope * 1  0/1672 (0.00%)  0 2/837 (0.24%)  2 0/846 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Cervical incompetence * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Psychiatric disorders       
Conversion disorder * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Renal failure acute * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Chronic obstructive pulmonary disease * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Pulmonary embolism * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 0/846 (0.00%)  0
Respiratory distress * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Respiratory failure * 1  0/1672 (0.00%)  0 0/837 (0.00%)  0 1/846 (0.12%)  1
Skin and subcutaneous tissue disorders       
Diabetic foot * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
Vascular disorders       
Hypotension * 1  0/1672 (0.00%)  0 1/837 (0.12%)  1 1/846 (0.12%)  1
Peripheral vascular disorder * 1  1/1672 (0.06%)  1 0/837 (0.00%)  0 0/846 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
QIV ID Vaccine Group TIV ID1 Vaccine Group TIV ID2 Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   883/1672 (52.81%)      395/837 (47.19%)      420/846 (49.65%)    
General disorders       
Injection site Pain  1  883/1656 (53.32%)  883 395/820 (48.17%)  395 420/838 (50.12%)  420
Injection site Erythema  1  607/1656 (36.65%)  607 279/820 (34.02%)  279 269/838 (32.10%)  269
Injection site Swelling  1  322/1655 (19.46%)  322 121/820 (14.76%)  121 123/838 (14.68%)  123
Injection site Induration  1  282/1656 (17.03%)  282 111/820 (13.54%)  111 94/837 (11.23%)  94
Injection site Pruritus  1  862/1656 (52.05%)  862 372/820 (45.37%)  372 374/838 (44.63%)  374
Malaise  1  459/1656 (27.72%)  459 216/820 (26.34%)  216 255/838 (30.43%)  255
Shivering  1  200/1656 (12.08%)  200 85/820 (10.37%)  85 94/838 (11.22%)  94
Musculoskeletal and connective tissue disorders       
Myalgia  1  564/1656 (34.06%)  564 238/820 (29.02%)  238 261/838 (31.15%)  261
Nervous system disorders       
Headache  1  548/1656 (33.09%)  548 257/820 (31.34%)  257 278/838 (33.17%)  278
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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: NCT01712984     History of Changes
Other Study ID Numbers: QID01
U1111-1124-8066 ( Other Identifier: WHO )
First Submitted: October 22, 2012
First Posted: October 24, 2012
Results First Submitted: December 15, 2013
Results First Posted: February 10, 2014
Last Update Posted: May 7, 2015