Study to Demonstrate Consistency of Three Lots of a Live-... | NCT04786444

Label	Type	Intervention Names
VLA1553 Lot 1	Active Comparator	Biological: Biological Vaccine VLA1553
VLA1553 Lot 2	Active Comparator	Biological: Biological Vaccine VLA1553
VLA1553 Lot 3	Active Comparator	Biological: Biological Vaccine VLA1553

Name	Type	Description	Arm Group Labels	Other Names
Biological Vaccine VLA1553	Biological	Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Measure	Description	Time Frame
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline		On Day 29 after single vaccination

Measure	Description	Time Frame
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers		on Day 8, 85 and Month 6
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects		on Day 8, 29, 85 and Month 6

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 45 years of age on the Day of screening
Able to provide informed consent
Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests
For women of childbearing potential:
1. practiced an adequate method of contraception during 30 days before screening
2. negative serum or urine pregnancy test at screening or vaccination, respectively
3. agreed to employ adequate birth control measures for the first three months post-vaccination.

Exclusion Criteria:

CHIKV infection in the past (self-reported), including suspected CHIKV infection; was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical study involving an investigational CHIKV vaccine
Acute or recent infection (and not symptom-free in the week prior to screening)
Tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
Received another live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively
Abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study
Medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions that posed a risk for participation in the study
History of immune-mediated or clinically relevant arthritis / arthralgia
History of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there had been surgical excision or treatment more than 5 years ago that was considered to have achieved a cure, the subject could be enrolled.
Known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination.
History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications)
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Pregnant, had plans to become pregnant during the first three months post-vaccination or lactating at the time of enrollment
Donation of blood, blood fractions or plasma within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or planned to donate blood or use blood products until Day 180 of the study
Rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
Known or suspected problem with alcohol or drug abuse as determined by the Investigator
Any condition that, in the opinion of the Investigator, could compromise the subjects well-being, could interfere with evaluation of study endpoints, or could limit the subject's ability to complete the study;
Committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
Participation in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study
Member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study.

Name	Affiliation	Role
Valneva Clinical Development	Valneva Austria GmbH	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
AMR Miami		Coral Gables	Florida	33134	United States
AMR Fort Myers

ID	Title	Description
FG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
FG001	VLA1553 Lot 2

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 7, 2021	Jul 21, 2022

ID	Title	Description
BG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
BG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
BG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000136 BG001137 BG002135 BG003408

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline

The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean Titer

On Day 29 after single vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000122 OG001118 OG002122

Title

Denominators

Categories

Title	Measurements
	OG0002556.7(2055.63 to 3179.80) OG0012767.7(2310.25 to 3315.65) OG0022613.7(2128.06 to 3210.17)

Secondary

Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers

The Per-Protocol population used for immunogenicity analyses, is based on participants without major protocol deviations that could impact the immune response.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean Titer

on Day 8, 85 and Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts

Secondary

Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects

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

Posted

Count of Participants

Participants

on Day 8, 29, 85 and Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts

Secondary

Proportion of Subjects With Seroconversion

At the specified time point the number of subjects with non-missing titers is stated.

Posted

Count of Participants

Participants

on Day 29, Day 85 and Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants

Secondary

Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline

Posted

Mean

Standard Deviation

Fold increase

on Day 8, 29, 85 and Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts

Secondary

Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline

Posted

Count of Participants

Participants

up to Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Secondary

Frequency of Solicited Injection Site

Posted

Count of Participants

Participants

10 days post vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Frequency of Solicited Systemic Reactions

Posted

Count of Participants

Participants

10 days post vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Severity of Solicited Injection Site

Posted

Count of Participants

Participants

10 days post vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Severity of Solicited Systemic Reactions

Posted

Count of Participants

Participants

10 days post vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination

Posted

Count of Participants

Participants

up to Day 29

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination

Posted

Count of Participants

Participants

up to Day 29

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Severity of Any Adverse Event During the Entire Study Period

Posted

Count of Participants

Participants

up to Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Frequency of Any Adverse Event During the Entire Study Period

Posted

Count of Participants

Participants

up to Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period

Posted

Count of Participants

Participants

up to Month 6

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Secondary

Severity of Any Adverse Event of Special Interest (AESI)

AESI Definition:

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

Fever (≥38.0°C [100.4°F] measured orally) and
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
Onset of symptoms 2 to 21 days after vaccination and
Duration of event ≥3 days.

Ongoing AESIs are monitored for entire study period

Posted

Count of Participants

Participants

within 2 to 21 days post-vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002

Secondary

Frequency of Any Adverse Event of Special Interest (AESI)

Posted

Count of Participants

Participants

Within 2 to 21 Days Post-vaccination

ID	Title	Description
OG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
OG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Fatique	General disorders	Systematic Assessment	EG00054 events53 affected136 at risk EG00149 events49 affected137 at risk EG00256 events55 affected135 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00056 events49 affected136 at risk EG00142 events42 affected137 at risk EG00259 events57 affected135 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00034 events33 affected136 at risk EG00136 events36 affected137 at risk EG00230 events30 affected135 at risk
Injection site pain	General disorders	Systematic Assessment	EG00026 events22 affected136 at risk EG00132 events30 affected137 at risk EG00226 events22 affected135 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00025 events24 affected136 at risk EG00122 events22 affected137 at risk EG00231 events26 affected135 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00017 events16 affected136 at risk EG00120 events20 affected137 at risk EG00217 events17 affected135 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG00017 events16 affected136 at risk EG00118 events18 affected137 at risk EG00219 events19 affected135 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected136 at risk EG0018 events8 affected137 at risk EG0027 events6 affected135 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected136 at risk EG0017 events7 affected137 at risk EG0023 events3 affected135 at risk
Neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0004 events4 affected136 at risk EG0013 events3 affected137 at risk EG0025 events5 affected135 at risk
Lymphadenopathy	Blood and lymphatic system disorders	Non-systematic Assessment	EG0004 events4 affected136 at risk EG0010 events0 affected137 at risk EG0024 events4 affected135 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0013 events3 affected137 at risk EG0022 events2 affected135 at risk
Chills	General disorders	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0011 events1 affected137 at risk EG0025 events5 affected135 at risk
Injection site induration	General disorders	Systematic Assessment	EG0003 events3 affected136 at risk EG0011 events1 affected137 at risk EG0023 events3 affected135 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0013 events3 affected137 at risk EG0021 events1 affected135 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0012 events2 affected137 at risk EG0023 events3 affected135 at risk
Aspartate aminotransferase increased	Investigations	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0011 events1 affected137 at risk EG0022 events2 affected135 at risk
Back Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 events3 affected136 at risk EG0010 events0 affected137 at risk EG0021 events1 affected135 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0010 events0 affected137 at risk EG0022 events2 affected135 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0012 events2 affected137 at risk EG0021 events1 affected135 at risk
Haemoglobin decreased	Investigations	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0012 events2 affected137 at risk EG0021 events1 affected135 at risk
Injection Site Swelling	General disorders	Systematic Assessment	EG0002 events2 affected136 at risk EG0010 events0 affected137 at risk EG0022 events2 affected135 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0012 events1 affected137 at risk EG0024 events3 affected135 at risk
Lymphopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0003 events3 affected136 at risk EG0010 events0 affected137 at risk EG0020 events0 affected135 at risk
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0011 events1 affected137 at risk EG0022 events2 affected135 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0010 events0 affected137 at risk EG0020 events0 affected135 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected137 at risk EG0025 events2 affected135 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0012 events2 affected137 at risk EG0020 events0 affected135 at risk
Ear infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0012 events2 affected137 at risk EG0020 events0 affected135 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected136 at risk EG0010 events0 affected137 at risk EG0022 events2 affected135 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0010 events0 affected137 at risk EG0020 events0 affected135 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected136 at risk EG0010 events0 affected137 at risk EG0020 events0 affected135 at risk
Injection site erythema	General disorders	Non-systematic Assessment	EG0004 events4 affected136 at risk EG0012 events2 affected137 at risk EG0025 events5 affected135 at risk

ID	Term
D018354	Alphavirus Infections
D001102	Arbovirus Infections
D000079426	Vector Borne Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases
D014777	Virus Diseases
D014036	Togaviridae Infections
D012327	RNA Virus Infections

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VLA1553 Lot 1	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	136	3	136	90	136
EG001	VLA1553 Lot 2	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	137	2	137	91	137
EG002	VLA1553 Lot 3	Biological Vaccine VLA1553: Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate	135	0	135	92	135

Term	Organ System	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0011 events1 affected137 at risk EG0020 events0 affected135 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0011 events1 affected137 at risk EG0020 events0 affected135 at risk
Cholecystitis acute	Hepatobiliary disorders	Non-systematic Assessment	EG0001 events1 affected136 at risk EG0010 events0 affected137 at risk EG0020 events0 affected135 at risk