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Trial record 1 of 1 for:    GRC00097
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Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively (GRC00097)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109222
Recruitment Status : Completed
First Posted : September 30, 2019
Results First Posted : December 17, 2020
Last Update Posted : March 28, 2022
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: Other
Condition Influenza
Interventions Biological: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation
Biological: Fluzone High-Dose vaccine, 2019-2020 formulation
Enrollment 90
Recruitment Details Participants were enrolled from 30 September 2019 to 7 October 2019 at 2 active sites in the United States.
Pre-assignment Details A total of 90 participants were enrolled and vaccinated in the study.
Arm/Group Title Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Hide Arm/Group Description Participants aged 6 to <36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP), a second dose was administered at Day 28. Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
Period Title: Overall Study
Started [1] 30 30 30
Completed 29 30 30
Not Completed 1 0 0
Reason Not Completed
Adverse Event             1             0             0
[1]
Vaccinated participants.
Arm/Group Title Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years Total
Hide Arm/Group Description Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged >=65 years received 1 dose of 0.5-mL Fluzone high-dose vaccine intramuscular injection at Day 0. Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 90
Hide Baseline Analysis Population Description
Analysis was performed on all enrolled and vaccinated participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
<=18 years
30
 100.0%
30
 100.0%
0
   0.0%
60
  66.7%
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%
30
 100.0%
30
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 90 participants
1.86  (0.29) 5.43  (1.45) 71.83  (5.16) 26.38  (32.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
Female
18
  60.0%
13
  43.3%
16
  53.3%
47
  52.2%
Male
12
  40.0%
17
  56.7%
14
  46.7%
43
  47.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   6.7%
0
   0.0%
2
   2.2%
White
29
  96.7%
25
  83.3%
30
 100.0%
84
  93.3%
More than one race
1
   3.3%
3
  10.0%
0
   0.0%
4
   4.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants Aged 6 Months to < 9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Hide Description Blood samples were collected from participants before first vaccination at Visit 1 (Day 0; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Time Frame Visit 1 (Day 0; pre-vaccination) and 28 days post-final vaccination at Visit 2/Visit 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all vaccinated participants i.e. the participants who have received at least 1 dose of the study vaccine. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years
Hide Arm/Group Description:
Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28.
Overall Number of Participants Analyzed 28 30
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 1
28
 100.0%
30
 100.0%
Visit 2
22
  78.6%
28
  93.3%
Visit 3
3
  10.7%
2
   6.7%
2.Primary Outcome
Title Number of Participants Aged >= 65 Years Who Provided Serum Samples for Analysis: Group 3
Hide Description Blood samples were collected from participants before vaccination at Visit 1 (Day 0; pre-vaccination) and 21 days after vaccination (Visit 2). Collected blood samples were provided to CBER for further analysis by WHO, CDC, and FDA to support formulation recommendations for subsequent influenza vaccines.
Time Frame Visit 1 (Day 0; pre-vaccination) and 21 days post-vaccination (Visit 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all vaccinated participants.
Arm/Group Title Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Hide Arm/Group Description:
Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 1
30
 100.0%
Visit 2
30
 100.0%
Time Frame Serious adverse events data were collected from Day 0 (post-vaccination) up to end of the study (i.e., up to Day 21 for adult participants [>= 65 years], Day 28 for child participants [6 to < 9 years] who had received 1 dose and Day 56 for participants who had received 2 doses).
Adverse Event Reporting Description Non-serious adverse event data were not planned to be collected in this study. Analysis was performed on all enrolled and vaccinated participants.
 
Arm/Group Title Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Hide Arm/Group Description Participants aged 6 to <36 months received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged 3 to 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged >=65 years received a 0.5-mL dose of Fluzone high-dose vaccine intramuscularly at Day 0.
All-Cause Mortality
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/30 (0.00%)      0/30 (0.00%)    
Infections and infestations       
Parainfluenzae virus infection  1  1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: Fluzone Quadrivalent Influenza Vaccine: 6 to < 36 Months Group 2: Fluzone Quadrivalent Influenza Vaccine: 3 to < 9 Years Group 3: Fluzone High-Dose Influenza Vaccine: >= 65 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0    
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.
The 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: Trial Transparency Team
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT04109222    
Other Study ID Numbers: GRC00097
U1111-1225-1118 ( Other Identifier: UTN )
First Submitted: September 26, 2019
First Posted: September 30, 2019
Results First Submitted: November 20, 2020
Results First Posted: December 17, 2020
Last Update Posted: March 28, 2022