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Trial record 1 of 1 for:    GRC00101
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Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

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ClinicalTrials.gov Identifier: NCT04551677
Recruitment Status : Completed
First Posted : September 16, 2020
Results First Posted : July 13, 2021
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 (Healthy Volunteers)
Interventions Biological: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation
Biological: Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
Enrollment 90
Recruitment Details Participants were enrolled from 16 September 2020 to 10 October 2020 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 Quadrivalent Influenza Vaccine: >=65 Years
Hide Arm/Group Description Participants aged 6 to less than (<) 36 months received a 0.5-milliliters (mL) dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 1. 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 1. Participants for whom 2 doses of influenza vaccine were recommended per ACIP, a second dose was administered at Day 28. Participants aged greater than or equal to (>=) 65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
Period Title: Overall Study
Started 29 31 30
Vaccinated 29 31 30
Completed 29 31 30
Not Completed 0 0 0
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 Quadrivalent 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 1. 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 1. 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 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1. Total of all reporting groups
Overall Number of Baseline Participants 29 31 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 29 participants 31 participants 30 participants 90 participants
<=18 years
29
 100.0%
31
 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 29 participants 31 participants 30 participants 90 participants
1.65  (0.518) 5.13  (1.75) 73.0  (4.03) 26.6  (33.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 participants 30 participants 90 participants
Female
13
  44.8%
12
  38.7%
16
  53.3%
41
  45.6%
Male
16
  55.2%
19
  61.3%
14
  46.7%
49
  54.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 31 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
4
  13.8%
1
   3.2%
0
   0.0%
5
   5.6%
White
23
  79.3%
30
  96.8%
30
 100.0%
83
  92.2%
More than one race
2
   6.9%
0
   0.0%
0
   0.0%
2
   2.2%
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 at first vaccination at Visit 1 (Day 1; 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 1; 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 had received at least 1 dose of the study vaccine. Here, 'number analyzed' = participants with available data for each specified category.
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 1. 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 1. 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 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 1 Number Analyzed 29 participants 31 participants
29 31
Visit 2 Number Analyzed 15 participants 30 participants
15 30
Visit 3 Number Analyzed 14 participants 1 participants
14 1
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 at first vaccination at Visit 1 (Day 1; 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 1; 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 Quadrivalent Influenza Vaccine: >=65 Years
Hide Arm/Group Description:
Participants aged >=65 years received a 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
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 Visit 1 (Day 1) up to end of the study (i.e., up to Day 21 for adult participants [>=65 years], up to Day 28 for child participants [6 to <9 years] who had received 1 dose and up to 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 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 Quadrivalent 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 1. 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 1. 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 0.7-mL dose of Fluzone High-Dose Quadrivalent vaccine intramuscularly at Day 1.
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 Quadrivalent Influenza Vaccine: >=65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (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 Quadrivalent Influenza Vaccine: >=65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/31 (0.00%)   0/30 (0.00%) 
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 Quadrivalent Influenza Vaccine: >=65 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
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 participant 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 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT04551677    
Other Study ID Numbers: GRC00101
U1111-1238-1821 ( Other Identifier: UTN )
First Submitted: August 27, 2020
First Posted: September 16, 2020
Results First Submitted: June 21, 2021
Results First Posted: July 13, 2021
Last Update Posted: March 28, 2022