Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults
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ClinicalTrials.gov Identifier: NCT04546724 |
Recruitment Status :
Completed
First Posted : September 14, 2020
Results First Posted : July 25, 2022
Last Update Posted : July 29, 2022
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Sponsor:
Valneva Austria GmbH
Information provided by (Responsible Party):
Valneva Austria GmbH
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | VLA1553 | Placebo |
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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
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Baseline Characteristics
Arm/Group Title | VLA1553 | Placebo | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 3082 participants | 1033 participants | 4115 participants | |
Female |
1681 54.5%
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570 55.2%
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2251 54.7%
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Male |
1401 45.5%
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463 44.8%
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1864 45.3%
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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%
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5 0.5%
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32 0.8%
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Asian |
51 1.7%
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17 1.6%
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68 1.7%
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Black or African American |
451 14.6%
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122 11.8%
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573 13.9%
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Native Hawaiian or other Pacific Islander |
13 0.4%
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5 0.5%
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18 0.4%
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White |
2456 79.7%
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853 82.6%
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3309 80.4%
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Other |
84 2.7%
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31 3.0%
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115 2.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Clinical Strategy Manager |
Organization: | Valn |
Phone: | +43 1 206 20 ext 0 |
EMail: | office@valneva.com |
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 |