Trial Outcomes & Findings for Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA (NCT NCT04942210)
NCT ID: NCT04942210
Last Updated: 2025-06-18
Results Overview
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF antibody (Ab) titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.
ACTIVE_NOT_RECRUITING
PHASE2
568 participants
28 days post dose 1 (Day 29)
2025-06-18
Participant Flow
This study was conducted at 11 sites in the United States of America from 01 July 2021 to 27 May 2022. Interim results are presented up to Year 2 follow-up, data base lock (DBL) date of 29 August 2024.
A total of 568 participants were randomized in a 2:1 ratio to receive a single subcutaneous (SC) injection of either yellow fever vaccine (vYF) vaccine or YF-VAX. A subset of participants enrolled at some sites provided an additional post-vaccination blood sample on Day 11 to assess the immune response elicited by both vaccines in terms of neutralizing antibody (NAb) titers and biological safety parameters on Days 1 and 11.
Participant milestones
| Measure |
vYF 0.5 mL
Participants received 1 dose of vYF vaccine 0.5 milliliter (mL) as a SC injection on Day 1.
|
YF-VAX 0.5 mL
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
382
|
186
|
|
Overall Study
Randomized and Vaccinated
|
379
|
186
|
|
Overall Study
COMPLETED
|
294
|
150
|
|
Overall Study
NOT COMPLETED
|
88
|
36
|
Reasons for withdrawal
| Measure |
vYF 0.5 mL
Participants received 1 dose of vYF vaccine 0.5 milliliter (mL) as a SC injection on Day 1.
|
YF-VAX 0.5 mL
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Deviation
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
16
|
7
|
|
Overall Study
Ongoing at the time of DBL date
|
60
|
25
|
|
Overall Study
Randomized but did not receive vaccination
|
3
|
0
|
Baseline Characteristics
Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
Baseline characteristics by cohort
| Measure |
vYF 0.5 mL
n=382 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
Total
n=568 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 11.87 • n=99 Participants
|
39.3 years
STANDARD_DEVIATION 11.88 • n=107 Participants
|
39.7 years
STANDARD_DEVIATION 11.87 • n=206 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
350 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
93 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
258 Participants
n=99 Participants
|
112 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple origin
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 days post dose 1 (Day 29)Population: The per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS). The FAS included the subset of randomized participants who received at least 1 dose of the study vaccine or control vaccine and had a valid post-vaccination blood sample result.
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF antibody (Ab) titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
vYF 0.5 mL
n=329 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=156 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Percentage of Yellow Fever (YF)-Naive Participants Who Achieved Seroconversion 28 Days Post Dose 1
|
99.7 percentage of participants
Interval 98.3 to 100.0
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
SECONDARY outcome
Timeframe: Days 1, 11, 29, Month 6, Years 1 and 2Population: The FAS included subset of randomized participants who received at least 1 dose of study vaccine or control vaccine and had a valid post-vaccination blood sample result. Day 11: a subset of participants enrolled at some sites provided an additional post-vaccination blood sample on Day 11 to assess the immune response elicited by both vaccines in terms of NAb titers. Only participants with data collected at specified timepoints are reported.
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value: compared to the Day 1 titers at each timepoint up to Month 6; and to the last planned previous timepoint from Year 1 onwards. The YF NAb titers were determined using a validated live virus MN assay. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
vYF 0.5 mL
n=369 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=183 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Achieved Seroconversion
Day 11
|
30.5 percentage of participants
Interval 19.2 to 43.9
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
|
Percentage of Participants Who Achieved Seroconversion
Day 29
|
97.8 percentage of participants
Interval 95.8 to 99.1
|
98.4 percentage of participants
Interval 95.3 to 99.7
|
|
Percentage of Participants Who Achieved Seroconversion
Month 6
|
94.7 percentage of participants
Interval 91.7 to 96.8
|
98.8 percentage of participants
Interval 95.8 to 99.9
|
|
Percentage of Participants Who Achieved Seroconversion
Year 1
|
4.4 percentage of participants
Interval 2.5 to 7.3
|
4.9 percentage of participants
Interval 2.1 to 9.4
|
|
Percentage of Participants Who Achieved Seroconversion
Year 2
|
1.4 percentage of participants
Interval 0.4 to 3.5
|
1.3 percentage of participants
Interval 0.2 to 4.7
|
SECONDARY outcome
Timeframe: Days 1, 11, 29, Month 6, Years 1 and 2Population: The FAS included subset of randomized participants who received at least 1 dose of study vaccine or control vaccine and had a valid post-vaccination blood sample result. Day 11: a subset of participants enrolled at some sites provided an additional post-vaccination blood sample on Day 11 to assess the immune response elicited by both vaccines in terms of NAb titers. Only participants with data collected at specified timepoints are reported.
Seroprotection was defined as NAb titers \>=threshold of 10 (1/dilution). The YF NAb titers were determined using a validated live virus MN assay. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
vYF 0.5 mL
n=371 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=183 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Percentage of Participants Who Achieved Seroprotection
Day 1
|
6.2 percentage of participants
Interval 4.0 to 9.2
|
4.4 percentage of participants
Interval 1.9 to 8.4
|
|
Percentage of Participants Who Achieved Seroprotection
Day 11
|
39.0 percentage of participants
Interval 26.5 to 52.6
|
61.3 percentage of participants
Interval 42.2 to 78.2
|
|
Percentage of Participants Who Achieved Seroprotection
Day 29
|
99.5 percentage of participants
Interval 98.1 to 99.9
|
99.5 percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Who Achieved Seroprotection
Month 6
|
98.8 percentage of participants
Interval 97.0 to 99.7
|
99.4 percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants Who Achieved Seroprotection
Year 1
|
97.5 percentage of participants
Interval 95.1 to 98.9
|
97.5 percentage of participants
Interval 93.8 to 99.3
|
|
Percentage of Participants Who Achieved Seroprotection
Year 2
|
98.6 percentage of participants
Interval 96.6 to 99.6
|
100 percentage of participants
Interval 97.6 to 100.0
|
SECONDARY outcome
Timeframe: Days 1, 11, 29, Month 6, Years 1 and 2Population: The FAS included subset of randomized participants who received at least 1 dose of study vaccine or control vaccine and had a valid post-vaccination blood sample result. Day 11: a subset of participants enrolled at some sites provided an additional post-vaccination blood sample on Day 11 to assess the immune response elicited by both vaccines in terms of NAb titers. Only participants with data collected at specified timepoints are reported.
GMTs of antibody against YF virus was measured using a validated live virus MN assay.
Outcome measures
| Measure |
vYF 0.5 mL
n=371 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=183 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Day 1
|
5.87 titer
Interval 5.43 to 6.35
|
5.56 titer
Interval 5.11 to 6.05
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Day 11
|
15.2 titer
Interval 9.69 to 23.7
|
42.6 titer
Interval 20.4 to 88.9
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Day 29
|
2540 titer
Interval 2218.0 to 2909.0
|
3004 titer
Interval 2495.0 to 3616.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Month 6
|
544 titer
Interval 467.0 to 633.0
|
702 titer
Interval 572.0 to 861.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Year 1
|
405 titer
Interval 342.0 to 480.0
|
552 titer
Interval 438.0 to 696.0
|
|
Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus
Year 2
|
196 titer
Interval 169.0 to 226.0
|
245 titer
Interval 200.0 to 301.0
|
SECONDARY outcome
Timeframe: Days 1, 11, 29, Month 6, Years 1 and 2Population: The FAS included subset of randomized participants who received at least 1 dose of study vaccine or control vaccine and had a valid post-vaccination blood sample result. Day 11: a subset of participants enrolled at some sites provided an additional post-vaccination blood sample on Day 11 to assess the immune response elicited by both vaccines in terms of NAb titers. Only participants with data collected at specified timepoints are reported.
GMTs of antibody against YF virus was measured using a validated live virus MN assay. Ratio was calculated as post-vaccination titer at Days 11, 29 and Month 6 to pre-vaccination titer at Day 1; post-vaccination titer at Year 1 to pre-vaccination titer at Month 6; post-vaccination titer at Year 2 to pre-vaccination titer at Year 1.
Outcome measures
| Measure |
vYF 0.5 mL
n=369 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=183 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus
Month 6/Day 1
|
49.6 ratio
Interval 42.3 to 58.1
|
66.3 ratio
Interval 53.7 to 81.8
|
|
Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus
Day 11/Day 1
|
2.16 ratio
Interval 1.49 to 3.12
|
5.57 ratio
Interval 2.96 to 10.5
|
|
Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus
Day 29/Day 1
|
227 ratio
Interval 194.0 to 264.0
|
280 ratio
Interval 227.0 to 344.0
|
|
Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus
Year 1/Month 6
|
0.742 ratio
Interval 0.661 to 0.832
|
0.777 ratio
Interval 0.658 to 0.916
|
|
Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus
Year 2/Year 1
|
0.473 ratio
Interval 0.426 to 0.524
|
0.426 ratio
Interval 0.367 to 0.495
|
SECONDARY outcome
Timeframe: Up to 30 minutes post vaccination on Day 1Population: The safety analysis set (SafAS) included all participants who received at least 1 dose of the study vaccines.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, ie, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
vYF 0.5 mL
n=379 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Unsolicited Systemic Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days post vaccination (Day 8)Population: The SafAS included all participants who received at least 1 dose of the study vaccines. Only participants with data collected are reported.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site of the study vaccine.
Outcome measures
| Measure |
vYF 0.5 mL
n=367 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=185 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
|
115 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days post vaccination (Day 15)Population: The SafAS included all participants who received at least 1 dose of the study vaccines. Only participants with data collected are reported.
A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF.
Outcome measures
| Measure |
vYF 0.5 mL
n=367 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=185 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
|
178 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days post vaccination (Day 29)Population: The SafAS included all participants who received at least 1 dose of the study vaccines.
An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, ie, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
vYF 0.5 mL
n=379 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
99 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study vaccine administration (Day 1) up to 6 months post vaccination, approximately up to Day 181Population: The SafAS included all participants who received at least 1 dose of the study vaccines.
An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. AESIs included serious hypersensitivity/allergic reactions, organ failure/serious viscerotropic events, serious neurologic events.
Outcome measures
| Measure |
vYF 0.5 mL
n=379 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) up to 6 Months Post-Vaccination
SAEs
|
6 Participants
|
2 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) up to 6 Months Post-Vaccination
AESIs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155Population: The SafAS included all participants who received at least 1 dose of the study vaccines.
An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Outcome measures
| Measure |
vYF 0.5 mL
n=379 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events and Deaths up to Day 1155
Deaths
|
2 Participants
|
1 Participants
|
|
Number of Participants With Serious Adverse Events and Deaths up to Day 1155
SAEs
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From the first dose of study vaccine administration (Day 1) up to end of study, approximately 5 yearsAn SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 11Population: Analysis was performed on a subset of participants enrolled at some sites who provided an additional post-vaccination blood sample to assess the biological safety parameters on Days 1 and 11. Only participants with data collected on Days 1 and 11 are reported.
Blood samples were collected at specified timepoints for assessment of biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), creatine phosphokinase (CPK), alkaline phosphatase (ALP), bilirubin (accompanied by any increase in liver function test (LFT) and normal LFT), creatinine and C-reactive protein (CRP). The intensity grading scale for laboratory abnormalities was pre-specified in the protocol. Number of participants with out-of-range biochemistry parameters are presented.
Outcome measures
| Measure |
vYF 0.5 mL
n=59 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=31 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: Bilirubin (Any increase in LFT)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: Creatinine
|
4 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: Creatinine
|
8 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: CRP
|
4 Participants
|
4 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: ALT
|
4 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: ALT
|
6 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: AST
|
3 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: AST
|
5 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: CPK
|
9 Participants
|
6 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: CPK
|
7 Participants
|
6 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: ALP
|
3 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: ALP
|
2 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: Bilirubin (Any increase in LFT)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 1: Bilirubin (Normal LFT)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: Bilirubin (Normal LFT)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Biochemistry Parameters
Day 11: CRP
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Days 1 and 11Population: Analysis was performed on a subset of participants enrolled at some sites who provided an additional post-vaccination blood sample to assess the biological safety parameters on Days 1 and 11. Only participants with data collected on Days 1 and 11 are reported.
Blood samples were collected at specified timepoints for assessment of hematology parameters: red blood cell count (RBC), hematocrit, mean corpuscular volume (MCV), monocytes, basophils, hemoglobin (Hb), white blood cell count (WBC) (increase and decrease), neutrophils and lymphocytes (decrease), eosinophils, platelets (decrease). The intensity grading scale for laboratory abnormalities was pre-specified in the protocol. Number of participants with out-of-range hematology parameters are presented.
Outcome measures
| Measure |
vYF 0.5 mL
n=59 Participants
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=31 Participants
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: RBC
|
11 Participants
|
5 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: RBC
|
7 Participants
|
4 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Hematocrit
|
12 Participants
|
6 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Hematocrit
|
10 Participants
|
5 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: MCV
|
7 Participants
|
3 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: MCV
|
5 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Monocytes
|
6 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Monocytes
|
6 Participants
|
4 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Basophils
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Basophils
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Hb
|
12 Participants
|
7 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Hb
|
10 Participants
|
6 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: WBC increase
|
2 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: WBC increase
|
13 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: WBC decrease
|
2 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: WBC decrease
|
13 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Neutrophils decrease
|
2 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Neutrophils decrease
|
8 Participants
|
3 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Lymphocytes decrease
|
0 Participants
|
0 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Lymphocytes decrease
|
2 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Eosinophils
|
1 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Eosinophils
|
1 Participants
|
2 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 1: Platelets decrease
|
4 Participants
|
1 Participants
|
|
Number of Participants With Out-of-Range Hematology Parameters
Day 11: Platelets decrease
|
5 Participants
|
0 Participants
|
Adverse Events
vYF 0.5 mL
YF-VAX 0.5 mL
Serious adverse events
| Measure |
vYF 0.5 mL
n=379 participants at risk
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 participants at risk
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.00%
0/379 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.54%
1/186 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/379 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.54%
1/186 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.26%
1/379 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
General disorders
Death
|
0.00%
0/379 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.54%
1/186 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/379 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.54%
1/186 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Infections and infestations
Cellulitis
|
0.26%
1/379 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.53%
2/379 • Number of events 2 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/379 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.54%
1/186 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.26%
1/379 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.26%
1/379 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.26%
1/379 • Number of events 1 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
0.00%
0/186 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
Other adverse events
| Measure |
vYF 0.5 mL
n=379 participants at risk
Participants received 1 dose of vYF vaccine 0.5 mL as a SC injection on Day 1.
|
YF-VAX 0.5 mL
n=186 participants at risk
Participants received 1 dose of YF-VAX vaccine 0.5 mL as a SC injection on Day 1.
|
|---|---|---|
|
General disorders
Injection Site Pain
|
27.7%
105/379 • Number of events 105 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
31.2%
58/186 • Number of events 58 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
General disorders
Malaise
|
29.0%
110/379 • Number of events 110 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
33.9%
63/186 • Number of events 63 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.1%
114/379 • Number of events 114 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
31.7%
59/186 • Number of events 59 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
Nervous system disorders
Headache
|
35.4%
134/379 • Number of events 134 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
37.6%
70/186 • Number of events 70 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
|
General disorders
Injection Site Erythema
|
7.1%
27/379 • Number of events 27 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
4.3%
8/186 • Number of events 8 • AEs, SAEs and all-cause mortality (deaths) were collected from the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155
Analysis was performed on the SafAS. Interim results are presented up to Year 2 follow-up, DBL date of 29 August 2024.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER