Trial Outcomes & Findings for Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years (NCT NCT05349617)
NCT ID: NCT05349617
Last Updated: 2024-12-13
Results Overview
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
21 days postvaccination
Results posted on
2024-12-13
Participant Flow
This was a multicenter study conducted in the United States, using 10 sites. Healthy adult participants ≥65 year of age were enrolled in this study. Recruitment Period was from May 12, 2022 to December 02, 2022.
Participant milestones
| Measure |
Group 1 - PXVX0317
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
207
|
|
Overall Study
COMPLETED
|
200
|
188
|
|
Overall Study
NOT COMPLETED
|
6
|
19
|
Reasons for withdrawal
| Measure |
Group 1 - PXVX0317
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
10
|
Baseline Characteristics
Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
Baseline characteristics by cohort
| Measure |
Group 1 - PXVX0317
n=206 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 Participants
Placebo is comprised of formulation buffer
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
71 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
71 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
93 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Height
|
166.4 cm
STANDARD_DEVIATION 9.42 • n=5 Participants
|
167.1 cm
STANDARD_DEVIATION 9.84 • n=7 Participants
|
166.8 cm
STANDARD_DEVIATION 9.63 • n=5 Participants
|
|
Weight
|
75.8 kg
STANDARD_DEVIATION 13.61 • n=5 Participants
|
77.2 kg
STANDARD_DEVIATION 13.29 • n=7 Participants
|
76.5 kg
STANDARD_DEVIATION 13.45 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.3 kg/m^2
STANDARD_DEVIATION 3.98 • n=5 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 3.94 • n=5 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Negative (<LLOQ)
|
201 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
397 Participants
n=5 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Positive (≥LLOQ)
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days postvaccinationPopulation: Immunogenicity Evaluable Population (IEP): All participants in the modified intent-to-treat (mITT) population who provide evaluable serum sample results for Day 22 within the required time frame of Day 19 through Day 27, inclusive; have no measurable anti-CHIKV SNA at Day 1; and have no important protocol deviation or other reason to be excluded as defined prior to unblinding. IEP is the primary population for all immunogenicity analyses.
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants
|
87.3 percentage of participants
Interval 81.8 to 91.3
|
1.1 percentage of participants
Interval 0.3 to 3.9
|
PRIMARY outcome
Timeframe: 21 days postvaccinationPopulation: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window (Day 19 through 27, inclusive), had no measurable anti-CHIKV human SNA assay titer at Day 1 (i.e., seronegative at baseline; participants missing a Day 1 titer were excluded from IEP), and had no important exclusionary protocol deviation or other reason for exclusion as defined prior to unblinding).
Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22
|
724 Titer
Interval 584.0 to 897.0
|
8 Titer
Interval 7.0 to 10.0
|
PRIMARY outcome
Timeframe: 7 days postvaccinationIncidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Outcome measures
| Measure |
Group 1 - PXVX0317
n=205 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=200 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Incidence of Solicited Adverse Events (AE)
|
25 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: 28 days postvaccinationPopulation: Safety population (vaccinated participants who provided safety assessment data), All ages pooled.
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Outcome measures
| Measure |
Group 1 - PXVX0317
n=206 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Incidence of Unsolicited AEs
|
26 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: 182 days postvaccinationPopulation: Safety population (vaccinated participants who provided safety assessment data), All ages pooled.
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Outcome measures
| Measure |
Group 1 - PXVX0317
n=206 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Incidence of Serious Adverse Events (SAE)
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 182 days postvaccinationPopulation: Safety population (vaccinated participants who provided safety assessment data), All ages pooled.
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Outcome measures
| Measure |
Group 1 - PXVX0317
n=206 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Incidence of Medically Attended Adverse Events (MAAE)
|
19 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 182 days postvaccinationPopulation: Safety population (vaccinated participants who provided safety assessment data), All ages pooled.
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Outcome measures
| Measure |
Group 1 - PXVX0317
n=206 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Incidence of Adverse Events of Special Interest (AESI)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 15 and 183 (14 and 182 days postvaccination, respectively)Population: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit.
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) with associated 95 percent CIs at Day 15 and Day 183.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
Day 15
|
82.3 percentage of participants
Interval 76.1 to 87.2
|
2.8 percentage of participants
Interval 1.2 to 6.5
|
|
Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
Day 183
|
75.5 percentage of participants
Interval 68.9 to 81.2
|
1.2 percentage of participants
Interval 0.3 to 4.1
|
SECONDARY outcome
Timeframe: Day 15, and 183 (14 and 182 days postvaccination, respectively)Population: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit.
Anti-CHIKV SNA GMTs with associated 95 percent CIs at Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Anti-CHIKV SNA GMTs at Days 15 and 183
Day 15
|
378 Titer
Interval 301.0 to 476.0
|
9 Titer
Interval 7.0 to 11.0
|
|
Anti-CHIKV SNA GMTs at Days 15 and 183
Day 183
|
233 Titer
Interval 194.0 to 280.0
|
8 Titer
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)Population: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.
Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Day 15
|
48.5 Fold increase in Anti-CHIKV SNA titre
Interval 40.1 to 58.7
|
1.2 Fold increase in Anti-CHIKV SNA titre
Interval 1.0 to 1.4
|
|
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Day 22
|
93.9 Fold increase in Anti-CHIKV SNA titre
Interval 78.0 to 113.1
|
1.1 Fold increase in Anti-CHIKV SNA titre
Interval 0.9 to 1.3
|
|
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Day 183
|
29.3 Fold increase in Anti-CHIKV SNA titre
Interval 25.0 to 34.4
|
1.0 Fold increase in Anti-CHIKV SNA titre
Interval 0.9 to 1.2
|
SECONDARY outcome
Timeframe: Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)Population: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window, had no measurable anti-CHIKV human SNA assay titer at Day 1, and had no important protocol deviation deemed exclusionary or other reason to be excluded as defined prior to unblinding). Number analyzed is number of participants with a sample result available at the indicated visit.
Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Outcome measures
| Measure |
Group 1 - PXVX0317
n=189 Participants
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=183 Participants
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
≥4-fold rise over baseline at Day 22
|
89.4 percentage of participants
Interval 84.2 to 93.0
|
1.1 percentage of participants
Interval 0.3 to 3.9
|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
SNA titers ≥ 15 at Day 15
|
94.5 percentage of participants
Interval 90.1 to 97.0
|
2.8 percentage of participants
Interval 1.2 to 6.5
|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
SNA titers ≥ 15 at Day 22
|
95.2 percentage of participants
Interval 91.2 to 97.5
|
1.1 percentage of participants
Interval 0.3 to 3.9
|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
SNA titers ≥ 15 at Day 183
|
92.9 percentage of participants
Interval 88.3 to 95.8
|
1.2 percentage of participants
Interval 0.3 to 4.1
|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
≥4-fold rise over baseline at Day 15
|
85.6 percentage of participants
Interval 79.8 to 90.0
|
2.8 percentage of participants
Interval 1.2 to 6.5
|
|
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
≥4-fold rise over baseline at Day 183
|
83.2 percentage of participants
Interval 77.1 to 87.9
|
1.2 percentage of participants
Interval 0.3 to 4.1
|
Adverse Events
Group 1 - PXVX0317
Serious events: 4 serious events
Other events: 46 other events
Deaths: 1 deaths
Group 2 - Placebo
Serious events: 3 serious events
Other events: 44 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1 - PXVX0317
n=206 participants at risk
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 participants at risk
Placebo is comprised of formulation buffer
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.00%
0/207 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Eye disorders
Glaucoma
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
COVID-19
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
Cellulitis
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.00%
0/207 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
Device related infection
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.00%
0/207 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.00%
0/207 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/206 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.48%
1/207 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
0.00%
0/207 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
Other adverse events
| Measure |
Group 1 - PXVX0317
n=206 participants at risk
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
|
Group 2 - Placebo
n=207 participants at risk
Placebo is comprised of formulation buffer
|
|---|---|---|
|
General disorders
Fatigue
|
6.3%
13/206 • Number of events 13 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
5.8%
12/207 • Number of events 12 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Nervous system disorders
Headache
|
4.4%
9/206 • Number of events 9 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
7.7%
16/207 • Number of events 16 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.3%
13/206 • Number of events 13 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
6.3%
13/207 • Number of events 13 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
|
General disorders
Injection Site Pain
|
5.3%
11/206 • Number of events 11 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
1.4%
3/207 • Number of events 3 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
A solicited AE is a protocol-specified AE about which the investigator (or designee) proactively asks the participants during a protocol-specified time period. A reactogenicity event may be considered as a solicited AE per discretion of the investigator. (Systematic Assessment) An unsolicited AE is an AE that is spontaneously reported by the participant or discovered by the investigator (Non-systematic Assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This is a multi-center study and agreement with investigators depends on the individual site contact.
- Publication restrictions are in place
Restriction type: OTHER