Trial Outcomes & Findings for First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults (NCT NCT04896086)
NCT ID: NCT04896086
Last Updated: 2025-04-27
Results Overview
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
7 days after product administration
Results posted on
2025-04-27
Participant Flow
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
Participant milestones
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
15
|
15
|
13
|
|
Overall Study
Completed Product Administration
|
5
|
15
|
15
|
13
|
13
|
|
Overall Study
COMPLETED
|
5
|
12
|
14
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Difficulties were experienced with vein access for blood sample collection
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant had a syncopal event during a blood draw
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=15 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
29.0 years
STANDARD_DEVIATION 7.3 • n=21 Participants
|
29.5 years
STANDARD_DEVIATION 8.0 • n=8 Participants
|
|
Age, Customized
21-30 years
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Age, Customized
31-40 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Age, Customized
41-50 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
25.0 kg/m^2
STANDARD_DEVIATION 2.1 • n=5 Participants
|
23.6 kg/m^2
STANDARD_DEVIATION 2.8 • n=7 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
23.0 kg/m^2
STANDARD_DEVIATION 4.5 • n=4 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 3.2 • n=21 Participants
|
24.9 kg/m^2
STANDARD_DEVIATION 3.9 • n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Mild
|
1 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · None
|
5 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis (Itching) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · None
|
5 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · None
|
4 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · None
|
5 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
11 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis (Itching) · None
|
5 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis (Itching) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis (Itching) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · None
|
4 Participants
|
12 Participants
|
9 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Mild
|
1 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · None
|
4 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Mild
|
1 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · None
|
5 Participants
|
14 Participants
|
14 Participants
|
12 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature (Fever) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature (Fever) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · None
|
5 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · None
|
4 Participants
|
14 Participants
|
15 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · None
|
5 Participants
|
14 Participants
|
14 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature (Fever) · None
|
5 Participants
|
15 Participants
|
15 Participants
|
13 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature (Fever) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · None
|
4 Participants
|
12 Participants
|
10 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Mild
|
1 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · None
|
5 Participants
|
13 Participants
|
12 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Mild
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 280, up to Week 40Population: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
SAEs were recorded from receipt of product administration through the last study visit at Week 40. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration
Unrelated to Study Product
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) Following Product Administration
Total Number of Participants who had SAE
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 28 days post product administration, up to Week 4Population: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Related to Study Product
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Unrelated to Study Product
|
2 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Total Number of Participants who had One or More Non-Serious Unsolicited AE
|
4 Participants
|
8 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 280, up to Week 40Population: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 40. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Unrelated to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Number of Participants With New Chronic Medical Condition
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 28 days post product administration, up to Week 4Population: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete Blood Count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Baseline, Day 0, Day 14, and 28. Creatinine results were collected at Baseline, Day 0 and Day 14. Institutional lab normal ranges as well as Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
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|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Neutrophil Count
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
WBC Count
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Bilirubin
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Hemoglobin
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Lymphocyte Count
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
ALT
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
AST
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 280, up to Week 40Population: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw.
Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the study product administration through the last study visit. ILI was defined as fever (temperature of 100 degrees F \[37.8 degrees C\] or greater) and a cough and/or sore throat in the absence of a known cause other than influenza. Collection of nasopharyngeal swabs were used for laboratory confirmation of influenza by polymerase chain reaction (PCR) in participants who met criteria for ILI. Subsequently, results of any reported laboratory testing for identification of pathogens were included for cases meeting initial criteria for ILI. The severity of illness in participants with laboratory confirmed influenza illness were captured on a case report form rather than on an Adverse Event (AE) form.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Number of Participants With Influenza or Influenza-like Illness (ILIs) Following Product Administration
Reported Influenza-like Illness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Influenza or Influenza-like Illness (ILIs) Following Product Administration
Influenza confirmed by clinical test
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 2 weeks after product administrationPopulation: Population included all enrolled participants who received study product (N=61). Two participants in Group 4B did not receive study product: for 1 participant, difficulties were experienced with vein access for blood sample collection, and 1 participant had a syncopal event during a blood draw. Twelve (12) out of 13 participants were analyzed in Group 4 at Week 2 post administration, as serum was not collected for one Group 4 participant at Week 2.
FluMos-v1-specific antibody titers were measured by Electrochemiluminescence Immunoassay (ECLIA) using a Meso Scale Discovery (MSD) platform. FluMos-v1 was biotinylated at an AviTag site located proximal to the C-terminus from the trimer foldon and bound to MSD streptavidin-coated plates. Serum samples collected at 2 weeks after product administration were assayed alongside healthy pooled human sera (not from this trial) as a reference standard. Binding of the reference standard to FluMos-v1 was assigned a stock concentration of 54000 arbitrary units per milliliter (AU/mL). Serial dilutions of sample within the dynamic range of the standard curve were interpolated to assign a sample concentration in AU/mL. Group geometric mean AU/mL values and 95% confidence intervals are reported.
Outcome measures
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 Participants
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 Participants
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 Participants
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 Participants
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 Participants
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Antibody Response Following the Completion of Vaccination
Week 0 Baseline (pre-administration)
|
53182 AU/mL
Interval 29435.0 to 96087.0
|
87179 AU/mL
Interval 64657.0 to 117547.0
|
76775 AU/mL
Interval 59572.0 to 98945.0
|
89289 AU/mL
Interval 67820.0 to 117554.0
|
90907 AU/mL
Interval 65566.0 to 126043.0
|
|
Antibody Response Following the Completion of Vaccination
Week 2 (14 days after product administration)
|
76333 AU/mL
Interval 43939.0 to 132610.0
|
160234 AU/mL
Interval 117213.0 to 219045.0
|
114327 AU/mL
Interval 91111.0 to 143458.0
|
142738 AU/mL
Interval 115468.0 to 176450.0
|
241119 AU/mL
Interval 188247.0 to 308841.0
|
Adverse Events
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 participants at risk
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 participants at risk
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 participants at risk
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 participants at risk
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 participants at risk
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant oligodendroglioma
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
Other adverse events
| Measure |
Part A, Group 1 (1A-1B): FluMos-v1 (20 mcg)
n=5 participants at risk
FluMos-v1 (20 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 2 (2A-2B): FluMos-v1 (60 mcg)
n=15 participants at risk
FluMos-v1 (60 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part A, Group 3 (3A-3B): Flucelvax (60 mcg)
n=15 participants at risk
Licensed QIV Flucelvax (60 mcg) administered intramuscularly (IM) by needle/syringe
Flucelvax: Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.
|
Part B, Group 4 (4A-4B): FluMos-v1 (100 mcg)
n=13 participants at risk
FluMos-v1 (100 mcg) administered intramuscularly (IM) by needle/syringe
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
Part B, Group 5 (5A-5B): FluMos-v1 (100 mcg) + Adjuplex (20% v/v)
n=13 participants at risk
FluMos-v1 (100 mcg) plus Adjuplex (20% v/v) administered intramuscularly (IM) by needle/syringe
VRC-GENADJ0110-AP-NV: Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.
VRC-FLUMOS0111-00-VP (FluMos-v1): FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
3/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
13.3%
2/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
15.4%
2/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Leukopenia
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
13.3%
2/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
2/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Hangover
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
13.3%
2/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
15.4%
2/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Infections and infestations
Viral infection
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Investigations
Blood pressure increased
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site pain
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
3/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
6/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
38.5%
5/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
100.0%
13/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site swelling
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
15.4%
2/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Chills
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
76.9%
10/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Malaise
|
20.0%
1/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
13.3%
2/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
26.7%
4/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
30.8%
4/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
84.6%
11/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
23.1%
3/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
30.8%
4/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
6.7%
1/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
53.8%
7/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
13.3%
2/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
3/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
23.1%
3/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
61.5%
8/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site erythema
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site pruritis
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
7.7%
1/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/15 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
23.1%
3/13 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were recorded from receipt of product administration through the visit scheduled 4 weeks after administration. At other time periods greater than 4 weeks after administration, only serious AEs, influenza or influenza-like illness (ILI) and new chronic medical conditions that required ongoing medical management were recorded through study completion at Day 280.
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
Additional Information
VRC Clinical Trials Program Leadership
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place