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Immunogenicity and Safety of Fluzone® Quadrivalent, Southern Hemisphere 2015 Formulation (Intramuscular Route)

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ClinicalTrials.gov Identifier: NCT03546192
Recruitment Status : Completed
First Posted : June 5, 2018
Results First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Fluzone Quadrivalent Influenza Vaccine
Enrollment 120
Recruitment Details Study participants were enrolled in 3 centers in the Philippines from 17 June 2015 to 26 June 2015.
Pre-assignment Details A total of 120 participants (60 for each group) were enrolled and vaccinated in the study.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older Total
Hide Arm/Group Description Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
Analysis was performed using the safety analysis set which included those participants who received at least 1 dose of study vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
35.3  (13.9) 68.0  (5.4) 51.7  (19.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
35
  58.3%
45
  75.0%
80
  66.7%
Male
25
  41.7%
15
  25.0%
40
  33.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Philippines Number Analyzed 60 participants 60 participants 120 participants
60
 100.0%
60
 100.0%
120
 100.0%
1.Primary Outcome
Title Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Hide Description Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer >=40 (1/dilution [dil]) at pre-vaccination and post-vaccination.
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis set included all participants who received one dose of study medication, had pre-and post-vaccination titers available and had not received vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1 (Pre-Vaccination)
41
  68.3%
37
  61.7%
A/H1N1 (Day 21 Post-Vaccination)
60
 100.0%
60
 100.0%
A/H3N2 (Pre-Vaccination)
26
  43.3%
27
  45.0%
A/H3N2 (Day 21 Post-Vaccination)
60
 100.0%
59
  98.3%
B Victoria (Pre-Vaccination)
48
  80.0%
37
  61.7%
B Victoria (Day 21 Post-Vaccination)
60
 100.0%
60
 100.0%
B Yamagata (Pre-Vaccination)
57
  95.0%
49
  81.7%
B Yamagata (Day 21 Post-Vaccination)
60
 100.0%
60
 100.0%
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)
Hide Description Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.
Time Frame Day 0 (pre-vaccination) and Day 21 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Immunogenicity analysis set.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions [dil])
A/H1N1 (Pre-Vaccination)
74.6
(49.9 to 112)
48.4
(33.2 to 70.5)
A/H1N1 (Day 21 Post-Vaccination)
2009
(1648 to 2448)
1083
(813 to 1442)
A/H3N2 (Pre-Vaccination)
27.8
(19.3 to 39.9)
34.4
(24.6 to 48.1)
A/H3N2 (Day 21 Post-Vaccination)
532
(390 to 726)
723
(525 to 994)
B Victoria (Pre-Vaccination)
80.0
(58.6 to 109)
44.9
(32.3 to 62.4)
B Victoria (Day 21 Post-Vaccination)
1052
(849 to 1303)
835
(654 to 1066)
B Yamagata (Pre-Vaccination)
209
(154 to 283)
118
(86.0 to 161)
B Yamagata (Day 21 Post-Vaccination)
2242
(1828 to 2749)
1070
(835 to 1371)
3.Primary Outcome
Title Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies
Hide Description Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.
Time Frame Day 0 (pre-vaccination), Day 21 (Post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Immunogenicity analysis set.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
A/H1N1
26.9
(17.1 to 42.4)
22.4
(14.7 to 34.0)
A/H3N2
19.1
(12.5 to 29.4)
21.0
(14.0 to 31.5)
B Victoria
13.1
(9.72 to 17.8)
18.6
(13.6 to 25.4)
B Yamagata
10.7
(7.95 to 14.5)
9.08
(6.49 to 12.7)
4.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: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and a post-vaccination titer >= 40 (1/dil). Significant increase was defined as a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.
Time Frame 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Immunogenicity analysis set.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
A/H1N1
52
  86.7%
52
  86.7%
A/H3N2
48
  80.0%
52
  86.7%
B Victoria
54
  90.0%
55
  91.7%
B Yamagata
51
  85.0%
47
  78.3%
5.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Hide Description A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: >=25 mm to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the safety analysis set.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
19
  31.7%
14
  23.3%
Grade 3 Pain
0
   0.0%
0
   0.0%
Any Erythema
0
   0.0%
0
   0.0%
Grade 3 Erythema
0
   0.0%
0
   0.0%
Any Swelling
0
   0.0%
1
   1.7%
Grade 3 Swelling
0
   0.0%
0
   0.0%
Any Induration
1
   1.7%
1
   1.7%
Grade 3 Induration
0
   0.0%
0
   0.0%
Any Ecchymosis
0
   0.0%
0
   0.0%
Grade 3 Ecchymosis
0
   0.0%
0
   0.0%
Any Fever
1
   1.7%
1
   1.7%
Grade 3 Fever
1
   1.7%
1
   1.7%
Any Headache
8
  13.3%
3
   5.0%
Grade 3 Headache
0
   0.0%
0
   0.0%
Any Malaise
8
  13.3%
2
   3.3%
Grade 3 Malaise
0
   0.0%
0
   0.0%
Any Myalgia
6
  10.0%
4
   6.7%
Grade 3 Myalgia
0
   0.0%
0
   0.0%
Any Shivering
2
   3.3%
1
   1.7%
Grade 3 Shivering
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance
Hide Description Solicited reactions listed in the CHMP note for guidance included: injection site induration >= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature > 38.0°C for at least one day, malaise, and shivering.
Time Frame Within 3 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the safety analysis set.
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description:
Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site induration
0
   0.0%
0
   0.0%
Injection site ecchymosis
0
   0.0%
0
   0.0%
Temperature
0
   0.0%
1
   1.7%
Malaise
7
  11.7%
2
   3.3%
Shivering
2
   3.3%
1
   1.7%
Time Frame AE data were collected from Day 0 (post-vaccination) up to Day 28 post vaccination .
Adverse Event Reporting Description A solicited reaction is an AE that is prelisted in the 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 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 onset post-vaccination.
 
Arm/Group Title Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Hide Arm/Group Description Participants aged 18 to 60 years received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0. Participants aged 61 years or older received one 0.5-mL dose of Fluzone Quadrivalent influenza vaccine, intramuscularly, at Day 0.
All-Cause Mortality
Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/60 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluzone Quadrivalent Influenza Vaccine: 18 to 60 Years Fluzone Quadrivalent Influenza Vaccine: 61 Years or Older
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/60 (36.67%)      17/60 (28.33%)    
General disorders     
Injection Site Pain  1  19/60 (31.67%)  19 14/60 (23.33%)  14
Malaise  1  8/60 (13.33%)  8 2/60 (3.33%)  2
Musculoskeletal and connective tissue disorders     
Myalgia  1  6/60 (10.00%)  6 4/60 (6.67%)  4
Nervous system disorders     
Headache  1  8/60 (13.33%)  8 3/60 (5.00%)  3
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Phone: 800-633-1610 ext 1#
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT03546192     History of Changes
Other Study ID Numbers: GRC85
U1111-1143-9256 ( Other Identifier: WHO )
First Submitted: May 22, 2018
First Posted: June 5, 2018
Results First Submitted: July 6, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 1, 2018