Trial Outcomes & Findings for A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine) (NCT NCT05072080)
NCT ID: NCT05072080
Last Updated: 2024-08-30
Results Overview
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3258 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2024-08-30
Participant Flow
This was a multicenter study conducted in the United States, using 47 sites. Healthy participants were enrolled in this study. Recruitment Period was from September 29, 2021 to October 06, 2022.
Participant milestones
| Measure |
Group 1
Group 1 - PXVX0317 lot A
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
Group 2 - PXVX0317 lot B
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot C
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
919
|
948
|
927
|
464
|
|
Overall Study
COMPLETED
|
803
|
837
|
832
|
430
|
|
Overall Study
NOT COMPLETED
|
116
|
111
|
95
|
34
|
Reasons for withdrawal
| Measure |
Group 1
Group 1 - PXVX0317 lot A
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
Group 2 - PXVX0317 lot B
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot C
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
65
|
70
|
58
|
23
|
|
Overall Study
Physician Decision
|
2
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
45
|
30
|
27
|
7
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject moved
|
1
|
3
|
5
|
2
|
|
Overall Study
Withdrawal by parent
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject was deployed
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject left site without receiving dose
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject incarcerated
|
0
|
1
|
0
|
1
|
|
Overall Study
Noncompliance (protocol, study, visits, e-diary, etc.)
|
0
|
2
|
1
|
1
|
|
Overall Study
Subject missed last visit (Day 183)
|
3
|
1
|
1
|
0
|
Baseline Characteristics
A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)
Baseline characteristics by cohort
| Measure |
Group 1
n=919 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=948 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=927 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=464 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
Total
n=3258 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
38 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
39 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
39 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
39 years
STANDARD_DEVIATION 14.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
452 Participants
n=5 Participants
|
506 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
1667 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
467 Participants
n=5 Participants
|
442 Participants
n=7 Participants
|
449 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
1591 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
165 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
577 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
735 Participants
n=5 Participants
|
760 Participants
n=7 Participants
|
731 Participants
n=5 Participants
|
379 Participants
n=4 Participants
|
2605 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
190 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
623 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
663 Participants
n=5 Participants
|
693 Participants
n=7 Participants
|
687 Participants
n=5 Participants
|
341 Participants
n=4 Participants
|
2384 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
86 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Height
|
171.4 cm
STANDARD_DEVIATION 10.03 • n=5 Participants
|
170.4 cm
STANDARD_DEVIATION 9.55 • n=7 Participants
|
170.7 cm
STANDARD_DEVIATION 10.02 • n=5 Participants
|
171.2 cm
STANDARD_DEVIATION 9.97 • n=4 Participants
|
170.9 cm
STANDARD_DEVIATION 9.89 • n=21 Participants
|
|
Weight
|
78.5 kg
STANDARD_DEVIATION 16.50 • n=5 Participants
|
78.4 kg
STANDARD_DEVIATION 16.08 • n=7 Participants
|
78.3 kg
STANDARD_DEVIATION 16.42 • n=5 Participants
|
77.6 kg
STANDARD_DEVIATION 16.42 • n=4 Participants
|
78.3 kg
STANDARD_DEVIATION 16.34 • n=21 Participants
|
|
Body Mass Index (BMI)
|
26.63 kg/m^2
STANDARD_DEVIATION 4.579 • n=5 Participants
|
26.89 kg/m^2
STANDARD_DEVIATION 4.480 • n=7 Participants
|
26.73 kg/m^2
STANDARD_DEVIATION 4.499 • n=5 Participants
|
26.38 kg/m^2
STANDARD_DEVIATION 4.570 • n=4 Participants
|
26.70 kg/m^2
STANDARD_DEVIATION 4.527 • n=21 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Negative (<LLOQ)
|
894 Participants
n=5 Participants
|
925 Participants
n=7 Participants
|
906 Participants
n=5 Participants
|
458 Participants
n=4 Participants
|
3183 Participants
n=21 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Positive (>=LLOQ)
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Baseline Anti-CHIKV SNA Serostatus
Missing
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: The number of participants assessed is the number of safety population participants who completed a memory aid following the vaccination.
Incidence 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
n=906 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=939 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=920 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=458 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Incidence of Solicited Adverse Events (AE)
|
319 Participants
|
373 Participants
|
366 Participants
|
124 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: 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
n=918 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=945 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=927 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=464 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Incidence of Unsolicited AEs
|
139 Participants
|
146 Participants
|
155 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: 182 days post-vaccinationPopulation: 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
n=918 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=945 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=927 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=464 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Incidence of Adverse Events of Special Interest (AESI)
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 182 days post-vaccinationPopulation: 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
n=918 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=945 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=927 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=464 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Incidence of Medically Attended Adverse Event (MAAE)
|
81 Participants
|
83 Participants
|
85 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: 182 days post-vaccinationPopulation: 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
n=918 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=945 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=927 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=464 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Event (SAE)
|
10 Participants
|
7 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22
|
97.81 percentage of participants (rounded)
Interval 97.2 to 98.3
|
1.18 percentage of participants (rounded)
Interval 0.5 to 2.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Anti-CHIKV SNA seroresponse rates and associated 95% confidence interval for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22 (Data Reported Per Arm)
|
98.1 percentage of participants
Interval 96.9 to 98.8
|
98.0 percentage of participants
Interval 96.9 to 98.8
|
97.3 percentage of participants
Interval 96.0 to 98.2
|
—
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22
|
1618 Titer
Interval 1522.0 to 1720.0
|
8 Titer
Interval 7.0 to 9.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - All Age Strata)
|
1592 Titer
Interval 1458.0 to 1739.0
|
1640 Titer
Interval 1503.0 to 1789.0
|
1622 Titer
Interval 1486.0 to 1771.0
|
—
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Adults 18 to \<46 years in Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Placebo group 4 does not apply for this PXVX0317 lot-to-lot consistency analysis.
Anti-CHIKV SNA GMTs and associated 95% CIs between all three pairs of PXVX0317 (CHIKV VLP vaccine) lots (104:105, 104:106, 105:106) in adults 18 to \<46 years of age in the IEP at Day 22. Placebo group 4 is not relevant for this lot-to-lot consistency analysis. Reported GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.
Outcome measures
| Measure |
Group 1
n=488 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=498 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=494 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (for Lot Comparison)
|
1857 titer
Interval 1641.0 to 2101.0
|
1887 titer
Interval 1672.0 to 2130.0
|
1950 titer
Interval 1724.0 to 2207.0
|
—
|
PRIMARY outcome
Timeframe: 21 days post-vaccinationPopulation: Adults 18 to \<46 years in Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Anti-CHIKV SNA GMTs and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo in adults 18 to \<46 years of age in the IEP at Day 22.
Outcome measures
| Measure |
Group 1
n=488 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=498 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=494 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=245 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - Adults 18 to <46)
|
1838 Titer
Interval 1638.0 to 2063.0
|
1866 Titer
Interval 1666.0 to 2089.0
|
1932 Titer
Interval 1721.0 to 2169.0
|
8 Titer
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) and placebo, difference (PXVX0317 minus placebo), and associated 95% CIs at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8
Day 15
|
96.8 percentage of participants
Interval 96.0 to 97.4
|
0.8 percentage of participants
Interval 0.3 to 2.2
|
—
|
—
|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8
Day 183
|
85.5 percentage of participants
Interval 84.0 to 86.9
|
1.5 percentage of participants
Interval 0.7 to 3.2
|
—
|
—
|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8
Day 8
|
46.6 percentage of participants
Interval 44.6 to 48.5
|
0.5 percentage of participants
Interval 0.1 to 1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Anti-CHIKV SNA seroresponse rates and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 15, Day 183, and Day 8, in that order, for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
n=424 Participants
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)
Day 15
|
96.6 percentage of participants
Interval 95.1 to 97.7
|
97.1 percentage of participants
Interval 95.7 to 98.0
|
96.5 percentage of participants
Interval 95.0 to 97.6
|
0.8 percentage of participants
Interval 0.3 to 2.2
|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)
Day 183
|
84.6 percentage of participants
Interval 81.8 to 87.0
|
85.9 percentage of participants
Interval 83.2 to 88.2
|
86.0 percentage of participants
Interval 83.4 to 88.2
|
1.5 percentage of participants
Interval 0.7 to 3.2
|
|
Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)
Day 8
|
45.8 percentage of participants
Interval 42.5 to 49.2
|
47.8 percentage of participants
Interval 44.4 to 51.1
|
46.1 percentage of participants
Interval 42.8 to 49.5
|
0.5 percentage of participants
Interval 0.1 to 1.7
|
SECONDARY outcome
Timeframe: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Day 8
|
93 Titer
Interval 87.0 to 100.0
|
7 Titer
Interval 6.0 to 8.0
|
—
|
—
|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Day 15
|
1096 Titer
Interval 1029.0 to 1167.0
|
8 Titer
Interval 7.0 to 9.0
|
—
|
—
|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183
Day 183
|
338 Titer
Interval 318.0 to 358.0
|
8 Titer
Interval 7.0 to 9.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Anti-CHIKV SNA GMTs with associated 95% CIs at Day 8, Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)
Day 8
|
90 Titer
Interval 82.0 to 99.0
|
97 Titer
Interval 88.0 to 106.0
|
93 Titer
Interval 85.0 to 103.0
|
—
|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)
Day 15
|
1073 Titer
Interval 981.0 to 1173.0
|
1112 Titer
Interval 1019.0 to 1215.0
|
1102 Titer
Interval 1007.0 to 1206.0
|
—
|
|
Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)
Day 183
|
331 Titer
Interval 304.0 to 360.0
|
342 Titer
Interval 315.0 to 372.0
|
340 Titer
Interval 313.0 to 370.0
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. Fold rise in geometric mean titer is the ratio of the post-baseline value to the baseline value (e.g. number of 2 represents a post-baseline doubling of geometric mean titer). Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
Day 8
|
12.5 Fold rise from baseline
Interval 11.6 to 13.3
|
1.0 Fold rise from baseline
Interval 0.9 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
Day 15
|
146.1 Fold rise from baseline
Interval 137.2 to 155.6
|
1.0 Fold rise from baseline
Interval 0.9 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
Day 22
|
215.7 Fold rise from baseline
Interval 203.0 to 229.3
|
1.1 Fold rise from baseline
Interval 0.9 to 1.2
|
—
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183
Day 183
|
45.0 Fold rise from baseline
Interval 42.4 to 47.8
|
1.1 Fold rise from baseline
Interval 1.0 to 1.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. Fold rise in geometric mean titer is the ratio of the post-baseline value to the baseline value (e.g. number of 2 represents a post-baseline doubling of geometric mean titer). Number analyzed is number of participants with a sample result available at both Day 1 and the indicated visit.
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
Day 8
|
12.0 Fold rise from baseline
Interval 10.9 to 13.3
|
12.9 Fold rise from baseline
Interval 11.7 to 14.2
|
12.5 Fold rise from baseline
Interval 11.3 to 13.8
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
Day 15
|
143.1 Fold rise from baseline
Interval 130.8 to 156.5
|
148.3 Fold rise from baseline
Interval 135.7 to 162.0
|
147.0 Fold rise from baseline
Interval 134.3 to 160.8
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
Day 22
|
212.3 Fold rise from baseline
Interval 194.4 to 231.8
|
218.6 Fold rise from baseline
Interval 200.4 to 238.6
|
216.3 Fold rise from baseline
Interval 198.1 to 236.2
|
—
|
|
Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183 (Data Reported Per Arm)
Day 183
|
44.1 Fold rise from baseline
Interval 40.5 to 48.0
|
45.6 Fold rise from baseline
Interval 41.9 to 49.6
|
45.4 Fold rise from baseline
Interval 41.7 to 49.4
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding). Groups 1, 2, and 3 are combined, as participants received same treatment of PXVX0317 (dose, adjuvant, schedule), with only difference being the lot of manufactured vaccine. Data is reported for PXVX0317 vaccinated vs. placebo.
Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.
Outcome measures
| Measure |
Group 1
n=2559 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=424 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
≥4-fold rise over baseline at Day 8
|
65.5 percentage of participants
Interval 63.6 to 67.3
|
0.7 percentage of participants
Interval 0.2 to 2.1
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
≥4-fold rise over baseline at Day 15
|
98.6 percentage of participants
Interval 98.0 to 99.0
|
0.8 percentage of participants
Interval 0.3 to 2.2
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
≥4-fold rise over baseline at Day 22
|
98.6 percentage of participants
Interval 98.1 to 99.0
|
1.4 percentage of participants
Interval 0.7 to 3.1
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
≥4-fold rise over baseline at Day 183
|
92.9 percentage of participants
Interval 91.8 to 93.9
|
1.5 percentage of participants
Interval 0.7 to 3.2
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
SNA titers ≥15 at Day 8
|
91.9 percentage of participants
Interval 90.7 to 92.9
|
1.2 percentage of participants
Interval 0.5 to 2.8
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
SNA titers ≥15 at Day 15
|
99.5 percentage of participants
Interval 99.1 to 99.7
|
0.8 percentage of participants
Interval 0.3 to 2.2
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
SNA titers ≥15 at Day 22
|
99.2 percentage of participants
Interval 98.8 to 99.5
|
1.7 percentage of participants
Interval 0.8 to 3.4
|
—
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183
SNA titers ≥15 at Day 183
|
99.0 percentage of participants
Interval 98.6 to 99.4
|
2.2 percentage of participants
Interval 1.2 to 4.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)Population: Immunogenicity evaluable population (randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV SNA sample within the analysis window, had no measurable anti-CHIKV SNA titer at Day 1, and had no reason to be excluded as defined prior to unblinding).
Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 8, Day 15, Day 22, and Day 183 for the IEP for all age strata combined. Number analyzed is number of participants with a sample result available at the indicated visit.
Outcome measures
| Measure |
Group 1
n=841 Participants
Group 1 - PXVX0317 lot 104
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2
n=860 Participants
Group 2 - PXVX0317 lot 105
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3
n=858 Participants
Group 3 - PXVX0317 lot 106
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4
Group 4 - Placebo
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
SNA titers ≥15 at Day 8
|
90.9 percentage of participants
Interval 88.8 to 92.7
|
93.6 percentage of participants
Interval 91.8 to 95.1
|
91.0 percentage of participants
Interval 88.9 to 92.8
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
SNA titers ≥15 at Day 15
|
99.4 percentage of participants
Interval 98.5 to 99.7
|
99.5 percentage of participants
Interval 98.8 to 99.8
|
99.5 percentage of participants
Interval 98.7 to 99.8
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
SNA titers ≥15 at Day 22
|
99.3 percentage of participants
Interval 98.5 to 99.7
|
99.2 percentage of participants
Interval 98.3 to 99.6
|
99.2 percentage of participants
Interval 98.3 to 99.6
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
SNA titers ≥15 at Day 183
|
98.9 percentage of participants
Interval 97.9 to 99.5
|
99.0 percentage of participants
Interval 98.0 to 99.5
|
99.2 percentage of participants
Interval 98.3 to 99.6
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
≥4-fold rise over baseline at Day 8
|
66.7 percentage of participants
Interval 63.5 to 69.9
|
66.0 percentage of participants
Interval 62.8 to 69.1
|
63.7 percentage of participants
Interval 60.4 to 66.9
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
≥4-fold rise over baseline at Day 15
|
98.1 percentage of participants
Interval 96.9 to 98.9
|
98.8 percentage of participants
Interval 97.8 to 99.3
|
98.8 percentage of participants
Interval 97.7 to 99.3
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
≥4-fold rise over baseline at Day 22
|
98.7 percentage of participants
Interval 97.7 to 99.3
|
98.7 percentage of participants
Interval 97.7 to 99.3
|
98.5 percentage of participants
Interval 97.4 to 99.1
|
—
|
|
Number and Percentage of Participants With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline at Days 8, 15, 22, and 183 (Data Reported Per Arm)
≥4-fold rise over baseline at Day 183
|
92.0 percentage of participants
Interval 89.9 to 93.8
|
93.5 percentage of participants
Interval 91.6 to 95.1
|
93.2 percentage of participants
Interval 91.2 to 94.7
|
—
|
Adverse Events
Group 1 - PXVX0317 Lot 104
Serious events: 10 serious events
Other events: 323 other events
Deaths: 0 deaths
Group 2 - PXVX0317 Lot 105
Serious events: 7 serious events
Other events: 375 other events
Deaths: 0 deaths
Group 3 - PXVX0317 Lot 106
Serious events: 6 serious events
Other events: 367 other events
Deaths: 1 deaths
Group 4 - Placebo
Serious events: 1 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - PXVX0317 Lot 104
n=918 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2 - PXVX0317 Lot 105
n=945 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3 - PXVX0317 Lot 106
n=927 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4 - Placebo
n=464 participants at risk
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Infections and infestations
Influenza
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Congenital, familial and genetic disorders
Encephalocele
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Immune system disorders
Anaphylactic reaction
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.22%
1/464 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 2 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Nervous system disorders
Basal ganglia infarction
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/927 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Psychiatric disorders
Depression
|
0.00%
0/918 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.11%
1/945 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.11%
1/918 • Number of events 1 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/945 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/927 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
0.00%
0/464 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
Other adverse events
| Measure |
Group 1 - PXVX0317 Lot 104
n=918 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 2 - PXVX0317 Lot 105
n=945 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 3 - PXVX0317 Lot 106
n=927 participants at risk
CHIKV VLP/adjuvant: CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
|
Group 4 - Placebo
n=464 participants at risk
Placebo: Placebo is comprised of formulation buffer
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
7.0%
64/918 • Number of events 64 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
7.9%
75/945 • Number of events 79 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
7.9%
73/927 • Number of events 78 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
6.7%
31/464 • Number of events 31 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
General disorders
Injection site pain
|
21.8%
200/918 • Number of events 200 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
24.8%
234/945 • Number of events 235 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
24.1%
223/927 • Number of events 226 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
10.6%
49/464 • Number of events 49 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
General disorders
Fatigue
|
18.4%
169/918 • Number of events 171 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
21.0%
198/945 • Number of events 201 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
20.5%
190/927 • Number of events 192 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
17.0%
79/464 • Number of events 79 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
General disorders
Chills
|
7.5%
69/918 • Number of events 69 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
8.4%
79/945 • Number of events 79 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
9.8%
91/927 • Number of events 92 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
3.2%
15/464 • Number of events 15 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.4%
151/918 • Number of events 152 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
17.6%
166/945 • Number of events 167 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
18.4%
171/927 • Number of events 173 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
9.7%
45/464 • Number of events 46 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
63/918 • Number of events 66 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
9.2%
87/945 • Number of events 88 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
8.1%
75/927 • Number of events 76 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
7.3%
34/464 • Number of events 36 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
|
Nervous system disorders
Headache
|
15.9%
146/918 • Number of events 150 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
18.6%
176/945 • Number of events 180 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
20.1%
186/927 • Number of events 193 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
16.8%
78/464 • Number of events 78 • Adverse events were collected from Day 1 through to the Day 183 end of study visit.
Solicited AE is a protocol-specified AE which is proactively asked of the participant during a protocol-specified time period (Systematic assessment). Unsolicited AE is spontaneously reported by participant or discovered by investigator (Non-systematic assessment).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This is a multi-center study and agreements with investigators depends on the individual site contract.
- Publication restrictions are in place
Restriction type: OTHER