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Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546724
Recruitment Status : Completed
First Posted : September 14, 2020
Results First Posted : July 25, 2022
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Chikungunya Virus Infection
Interventions Biological: VLA1553
Biological: Placebo
Enrollment 4124
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Period Title: Overall Study
Started [1] 3082 1033
Completed [2] 2959 998
Not Completed 123 35
Reason Not Completed
Withdrawal by Subject             37             10
Adverse Event             1             1
Lost to Follow-up             30             10
Physician Decision             4             1
Subject Moved             2             0
Subject Praticipating in another trial             0             1
subjects did not have a Day29 or later visits . These subjects were considered as "Not completed".             49             12
[1]
In total, 4,124 subjects were randomized, of whom 3,089 subjects were randomized in the VLA1553 arm and 1,035 subjects in the placebo arm. Six subjects in VLA1553 arm and 1 in placebo arm did not receive their vaccination. All vaccinated subjects were included in the Safety population, except for 1 subject that was vaccinated twice.
[2]
numbers show subjects reached day 29
Arm/Group Title VLA1553 Placebo Total
Hide Arm/Group Description VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo Total of all reporting groups
Overall Number of Baseline Participants 3082 1033 4115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3082 participants 1033 participants 4115 participants
45.1  (15.44) 45.0  (15.59) 45.0  (15.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3082 participants 1033 participants 4115 participants
Female
1681
  54.5%
570
  55.2%
2251
  54.7%
Male
1401
  45.5%
463
  44.8%
1864
  45.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 3082 participants 1033 participants 4115 participants
American Indian or Alaska Native
27
   0.9%
5
   0.5%
32
   0.8%
Asian
51
   1.7%
17
   1.6%
68
   1.7%
Black or African American
451
  14.6%
122
  11.8%
573
  13.9%
Native Hawaiian or other Pacific Islander
13
   0.4%
5
   0.5%
18
   0.4%
White
2456
  79.7%
853
  82.6%
3309
  80.4%
Other
84
   2.7%
31
   3.0%
115
   2.8%
1.Primary Outcome
Title Number of Participants With a Seroprotective CHIKV Antibody Level for Baseline Negative Subjects 28 Days Post-vaccination
Hide Description

Seroprotection rate, based on a surrogate of protection agreed with FDA

Assay used for analysis is based on µPRNT (Micro Plaque Reduction Neutralization Test). Participants at pre-selected sites were included, if they had available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
Time Frame on Day 29 after single vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Measure Type: Count of Participants
Unit of Measure: Participants
206
  98.6%
0
   0.0%
58
  98.3%
0
   0.0%
2.Secondary Outcome
Title CHIKV-specific Neutralizing Antibody Titers
Hide Description CHIKV-specific Neutralizing Antibody Titers on Day 8, and Day 29 Postvaccination as Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) Assay
Time Frame Until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: Antibody Titers
Visit 2 - Day 8
13.6
(12.21 to 15.20)
10.2
(9.92 to 10.50)
13.2
(10.90 to 16.08)
10.0
(10.0 to 10.0)
Visit 3 - Day 29
3244.0
(2835.87 to 3710.90)
10.1
(9.89 to 10.33)
3361.6
(2483.14 to 4550.80)
10.0
(10.0 to 10.0)
3.Secondary Outcome
Title Number of Participants With Seroprotective CHIKV Antibody Level
Hide Description Seroprotection rate, based on a surrogate of protection agreed with FDA Seroprotective CHIKV Antibody Level Defined as μPRNT (Micro Plaque Reduction Neutralization Test) for Baseline Negative Subjects
Time Frame Until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 2 - Day 8 Number Analyzed 199 participants 70 participants 53 participants 23 participants
2
   1.0%
0
   0.0%
2
   3.8%
0
   0.0%
Visit 3 - Day 29 Number Analyzed 209 participants 73 participants 59 participants 23 participants
206
  98.6%
0
   0.0%
58
  98.3%
0
   0.0%
4.Secondary Outcome
Title Number of Participants With Seroconversion
Hide Description Seroconversion was defined as CHIKV-specific neutralizing antibody titer of ≥ 20 based on µPRNT (Micro Plaque Reduction Neutralization Test) for baseline negative subjects
Time Frame Until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Measure Type: Count of Participants
Unit of Measure: Participants
207
  99.0%
1
   1.4%
58
  98.3%
0
   0.0%
5.Secondary Outcome
Title Fold "Change" of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Hide Description

Fold Change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline

calculation of fold change: Day 8/ Baseline and Day 29/ Baseline
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Mean (Standard Deviation)
Unit of Measure: fold increase
Visit 2 - Day 8 4.36  (30.207) 1.03  (0.176) 2.04  (3.308) 1.00  (0.000)
Visit 3 - Day 29 457.44  (383.427) 1.02  (0.140) 503.65  (416.298) 1.00  (0.000)
6.Secondary Outcome
Title Number of Participants Reaching an X-fold Change in CHICKV-specific Neutralizing Antibody Titer Compared to Baseline
Hide Description Number of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol population used for immunogenicity analyses, is based on participants who have available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
Arm/Group Title VLA1553 18-64 Years Placebo 18-64 Years VLA1553 ≥65 Years Placebo ≥65 Years
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 209 73 59 23
Measure Type: Count of Participants
Unit of Measure: Participants
Visit 2 - Day 8: subjects reaching 4-fold increase Number Analyzed 199 participants 70 participants 53 participants 23 participants
17
   8.5%
0
   0.0%
5
   9.4%
0
   0.0%
Visit 2 - Day 8 subjects reaching 8-fold increase Number Analyzed 199 participants 70 participants 53 participants 23 participants
7
   3.5%
0
   0.0%
3
   5.7%
0
   0.0%
Visit 2 - Day 8 subjects reaching 16-fold increase Number Analyzed 199 participants 70 participants 53 participants 23 participants
2
   1.0%
0
   0.0%
2
   3.8%
0
   0.0%
Visit 2 - Day 8: subjects reaching 64-fold increase Number Analyzed 199 participants 70 participants 53 participants 23 participants
2
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
Visit 3 - Day 29: Subjects reaching 4-fold increase Number Analyzed 209 participants 73 participants 59 participants 23 participants
207
  99.0%
0
   0.0%
58
  98.3%
0
   0.0%
Visit 3 - Day 29: Subjects reaching 8-fold increase Number Analyzed 209 participants 73 participants 59 participants 23 participants
207
  99.0%
0
   0.0%
58
  98.3%
0
   0.0%
Visit 3 - Day 29: Subjects reaching 16-fold increase Number Analyzed 209 participants 73 participants 59 participants 23 participants
206
  98.6%
0
   0.0%
58
  98.3%
0
   0.0%
Visit 3 - Day 29: Subjects reaching 64-fold increase Number Analyzed 209 participants 73 participants 59 participants 23 participants
201
  96.2%
0
   0.0%
56
  94.9%
0
   0.0%
7.Secondary Outcome
Title Unsolicited AEs
Hide Description Number of Participants with Unsolicited Adverse Events
Time Frame Until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
639
  20.7%
126
  12.2%
8.Secondary Outcome
Title Solicited Injection Site AEs
Hide Description Number of Participants with solicited injection site reactions
Time Frame within 10 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
Any Solicited Injection Site Adverse Event
456
  14.8%
113
  10.9%
Tenderness
320
  10.4%
83
   8.0%
Pain
189
   6.1%
37
   3.6%
Erythema/Redness
44
   1.4%
14
   1.4%
Induration
43
   1.4%
8
   0.8%
Swelling
22
   0.7%
9
   0.9%
9.Secondary Outcome
Title Solicited Systemic AEs
Hide Description Number of Participants with solicited systemic reactions
Time Frame within 10 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
Any Solicited Systemic Adverse Event
1529
  49.6%
273
  26.4%
Headache
951
  30.9%
148
  14.3%
Fatigue
858
  27.8%
128
  12.4%
Myalgia
718
  23.3%
71
   6.9%
Arthralgia
490
  15.9%
49
   4.7%
Fever
405
  13.1%
7
   0.7%
Nausea
335
  10.9%
56
   5.4%
Rash
67
   2.2%
6
   0.6%
Vomiting
58
   1.9%
10
   1.0%
10.Secondary Outcome
Title Adverse Events
Hide Description Number of Participants with any Adverse Events
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
Mild
1287
  41.8%
314
  30.4%
Moderate
430
  14.0%
69
   6.7%
Severe
65
   2.1%
7
   0.7%
11.Secondary Outcome
Title Related Adverse Events
Hide Description Number of Participants with any related Adverse Events
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
1558
  50.6%
311
  30.1%
12.Secondary Outcome
Title Serious Adverse Event
Hide Description Number of Participants with any Serious Adverse Events
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
14
   0.5%
4
   0.4%
13.Secondary Outcome
Title Related Serious Adverse Event
Hide Description Number of Participants with any Related Serious Adverse Events
Time Frame until Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.1%
0
   0.0%
14.Secondary Outcome
Title Adverse Event of Special Interest
Hide Description

Number of Participants with any Adverse Event of Special Interest

AESI Definition:

The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations will receive particular consideration:

  1. Fever (≥38.0°C [100.4°F] measured orally) and
  2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus [foot plant] and edema of the face and extremities), polyadenopathies; and
  3. Onset of symptoms 2 to 21 days after vaccination and
  4. Duration of event ≥3 days.
Time Frame within 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
10
   0.3%
1
   0.1%
15.Secondary Outcome
Title Related Adverse Event of Special Interest
Hide Description

Number of Participants with any Related Adverse Event of Special Interest

AESI Definition:

The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations will receive particular consideration:

  1. Fever (≥38.0°C [100.4°F] measured orally) and
  2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus [foot plant] and edema of the face and extremities), polyadenopathies; and
  3. Onset of symptoms 2 to 21 days after vaccination and
  4. Duration of event ≥3 days.
Time Frame within 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description:
VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Overall Number of Participants Analyzed 3082 1033
Measure Type: Count of Participants
Unit of Measure: Participants
9
   0.3%
1
   0.1%
Time Frame 29 Days
Adverse Event Reporting Description

Solicited AEs are collected by systematic assessment through subject eDiaries (within 10 days post-vaccination):injection site AEs (pain, tenderness, induration, swelling, erythema/redness) or systemic AEs (headache, myalgia, arthralgia, fever, vomiting, nausea, rash, fatigue). Unsolicited AEs, and SAEs are collected by non-systematic assessment up to Day 180.

AESI is defined as symptoms suggestive of CHIKV infection up to 21 days after vaccination and collected by systematic assessment.
 
Arm/Group Title VLA1553 Placebo
Hide Arm/Group Description VLA1553: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
All-Cause Mortality
VLA1553 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3082 (0.00%)      0/1033 (0.00%)    
Hide Serious Adverse Events
VLA1553 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/3082 (0.45%)      4/1033 (0.39%)    
Cardiac disorders     
Atrial fibrillation *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Endocrine disorders     
Inappropriate antidiuretic hormone secretion *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrage *  0/3082 (0.00%)  0 1/1033 (0.10%)  1
Hepatobiliary disorders     
Cholecystitis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Infections and infestations     
Appendicitis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
COVID-19 *  0/3082 (0.00%)  0 1/1033 (0.10%)  1
Complicated appendicitis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Pneumonia *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Pyelonephritis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Ankle fracture *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Fall *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Fibula fracture *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Overdose *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Tendon rupture *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Tibia fracture *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Metabolism and nutrition disorders     
Glucose tolerance impaired *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Hypokalaemia *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Mylgia *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Nervous system disorders     
Cerebellar haemorrhage *  0/3082 (0.00%)  0 1/1033 (0.10%)  1
Psychiatric disorders     
Suicidal ideation *  2/3082 (0.06%)  2 1/1033 (0.10%)  1
Anxiety *  0/3082 (0.00%)  0 1/1033 (0.10%)  1
Bipolar disorder *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Depression *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Hydronephrosis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Nephrolithiasis *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism *  1/3082 (0.03%)  1 0/1033 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
VLA1553 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1649/3082 (53.50%)      342/1033 (33.11%)    
Blood and lymphatic system disorders     
Neutropenia * [1]  33/3082 (1.07%)  33 1/1033 (0.10%)  1
Gastrointestinal disorders     
Nausea †  339/3082 (11.00%)  364 59/1033 (5.71%)  64
Vomiting †  61/3082 (1.98%)  62 12/1033 (1.16%)  12
Diarrhoea *  39/3082 (1.27%)  39 3/1033 (0.29%)  3
General disorders     
Fatigue †  862/3082 (27.97%)  959 130/1033 (12.58%)  140
Injection site pain †  407/3082 (13.21%)  541 100/1033 (9.68%)  124
Pyrexia *  415/3082 (13.47%)  442 8/1033 (0.77%)  8
Injection site erythema *  44/3082 (1.43%)  44 14/1033 (1.36%)  14
Chills *  53/3082 (1.72%)  53 2/1033 (0.19%)  2
Musculoskeletal and connective tissue disorders     
Myalgia *  726/3082 (23.56%)  787 73/1033 (7.07%)  84
Arthralgia *  512/3082 (16.61%)  563 53/1033 (5.13%)  62
Induration †  43/3082 (1.40%)  44 8/1033 (0.77%)  8
Back Pain *  34/3082 (1.10%)  36 6/1033 (0.58%)  6
Nervous system disorders     
Headache †  961/3082 (31.18%)  1115 151/1033 (14.62%)  177
Skin and subcutaneous tissue disorders     
Rash †  70/3082 (2.27%)  78 9/1033 (0.87%)  9
*
Indicates events were collected by non-systematic assessment
[1]
only analyzed from the immunogenicity subset
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Strategy Manager
Organization: Valn
Phone: +43 1 206 20 ext 0
EMail: office@valneva.com
Layout table for additonal information
Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT04546724    
Other Study ID Numbers: VLA1553-301
First Submitted: September 4, 2020
First Posted: September 14, 2020
Results First Submitted: May 18, 2022
Results First Posted: July 25, 2022
Last Update Posted: July 29, 2022