Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Valneva Austria GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This was a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the full dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The dose of VLA1553 or control was administered as single vaccination on Day 1. Overall, approximately 750 male and female participants aged 12 years to <18 years were enrolled into the study. After completion of the trial, a Post Trial Access program was performed to offer the VLA1553 vaccine to all placebo recipients.
This was a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 study comprising 754 participants aged 12 years to <18 years randomized in a 2:1 ratio to the live-attenuated CHIKV vaccine candidate (VLA1553) or placebo. The dose of lyophilized VLA1553 or placebo was administered as a single intramuscular vaccination. Subjects in this study were stratified by baseline serostatus. The primary objective of the study was to evaluate the immunogenicity and safety of the full dose of VLA1553 28 days following the single vaccination. Immunogenicity evaluations in the immunogenicity subset included the proportion of subjects with neutralizing CHIKV antibody titers above the seroresponse threshold. The surrogate of protection reasonably likely to predict clinical benefit has been established in non-human primate passive transfer studies using human sera from the Phase 1 study. Safety data collection and immunogenicity were assessed until Month 12.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | VLA1553 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active | Biological | Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose (0.5 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection | Percentage of subjects with a seroprotective CHIKV antibody level determined as µPRNT50>= 150 (Micro Plaque Reduction Neutralization Test 50%) for baseline negative subjects 28 days post-vaccination. | On study Day 29,which is 28 days after single vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| CHIKV-specific Antibody Titers as GMTs up to 1 Year | Immune response as measured by CHIKV-specific neutralizing antibody titers on Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination as determined by μPRNT | On study Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination |
Not provided
Inclusion Criteria:
male or female adolescents from the 12th birthday to the last day before the 18th birthday at the time of vaccination;
written informed consent by the subject's legal representative(s), and written informed assent of the subject;
generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
seropositive for previous CHIKV exposure (i.e. IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e. IgM-/IgG-) as screened by CHIKV-specific ELISA.
for women of childbearing potential:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fernanda C Boulos, MD, MSc | Butantan Institute | Study Chair |
| Valneva Austria GmbH | Valneva Austria GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CECOR - Centro Oncológico de Roraima | Boa Vista | Acre | 69304-015 | Brazil | ||
| Fundação de Medicina Tropical Dr. Heitor Vieira Dourado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41380703 | Result | Buerger V, Pfeiffer A, Schoengrundner P, Seebacher J, Hochreiter R, Kosulin K, Zoihsl O, Weisova P, Mader R, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in adolescents: final results from a 12-month, double-blind, randomised, placebo-controlled, phase 3 trial in endemic areas of Brazil. Lancet Infect Dis. 2026 Apr;26(4):417-428. doi: 10.1016/S1473-3099(25)00631-0. Epub 2025 Dec 8. | |
| 39243794 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
33 participants excluded from the Protocol population due to major protocol deviations.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active | VLA1553 Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose |
| FG001 | Placebo | Placebo Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population - All the participants who received the study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active | VLA1553 Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Seroprotection | Percentage of subjects with a seroprotective CHIKV antibody level determined as µPRNT50>= 150 (Micro Plaque Reduction Neutralization Test 50%) for baseline negative subjects 28 days post-vaccination. | Per protocol population - Seronegative at baseline and without major protocol deviations that could impact the immune response | Posted | Number | participants | On study Day 29,which is 28 days after single vaccination |
|
up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | VLA1553 Active: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment | Participant experienced lower limb fracture, classified as serious due to hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fernanda Castro Boulos | Instituto Butantan | +55 11 3723-6797 | fernanda.boulos@fundacaobutantan.org.br |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2022 | Apr 7, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2024 | Apr 7, 2026 | SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| ID | Term |
|---|---|
| D018354 | Alphavirus Infections |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo (0.5 mL) |
|
| Seroprotection up to 1 Year |
Percentage of subjects with seroprotective levels defined as μPRNT50 ≥ 150 for μPRNT baseline negative subjects on Day 8, Day 85, Day 180 and Month 12 post-vaccination as determined by μPRNT. |
| On the study Day 8, Day 85, Day 180, and Day 365 (Month 12) after vaccination |
| Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline | Percentage of subjects with seroconversion defined as > 4-fold increase of μPRNT50 compared to baseline at Day 29, Month 6 and Month 12 as determined by μPRNT assay | On study Day 29, Day 180 and Month 12 after vaccination |
| Fold Change in Neutralizing Antibodies Compared to Baseline | Fold change of CHIKV-specific neutralizing antibody titers determined by μPRNT assay at Days 8, 29, 85, 180 and at Month 12 post-vaccination as compared to baseline | On study Day 8, 29, 85, 180 and Month 12 after vaccination |
| X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline | Percentage of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay | 365 days (12 months) after vaccination |
| Immunogenicity (GMT) Per Baseline Serostatus | CHIKV-specific neutralizing antibodies, determined by μPRNT assay at Days 1, 8, 29, 85, 180, and Month 12 post-vaccination stratified by μPRNT baseline serostatus. | On study Day 1, 8, 29, 85, 180 and Month 12 after vaccination |
| Number of Participants With Unsolicited Adverse Events | Frequency of unsolicited AEs at Day 29 and Day 180 (6 months) post-vaccination | On study Day 29 and Day 180 after vaccination |
| Number of Participants With Solicited Adverse Events | Frequency of solicited injection site and systemic adverse events within ten days post-vaccination | up to 10 days after vaccination |
| Number of Participants With Adverse Event of Special Interest | Frequency of any Adverse Event of Special Interest: The following cluster of symptoms with or without remissions or exacerbations received particular consideration and were defined as early onset AESI:
| until 365 days (12 months) after vaccination |
| Number of Participants With Serious Adverse Events | Frequency and relatedness of any Serious Adverse Event (SAE) during the entire study period | until 365 days (12 months) after vaccination |
| Manaus |
| Amazonas |
| 69040-000 |
| Brazil |
| Núcleo de Medicina Tropical - Universidade Federal do Ceará | Fortaleza | Ceará | 60020-181 | Brazil |
| Associação Obras Sociais Irmã Dulce / Centro de Pesquisa ClÃnica - CPEC | Salvador | Estado de Bahia | 40415-180 | Brazil |
| Centro de Pesquisa e Desenvolvimento de Fármacos (CPDF) - Universidade Federal de Minas Gerais, Instituto de Ciências Biológicas | Belo Horizonte | Minas Gerais | 31270-010 | Brazil |
| Real Hospital Português de Beneficência em Pernambuco | Recife | Pernambuco | 52010-075 | Brazil |
| Centro de Pesquisas ClÃnicas Universidade Federal Sergipe | Aracaju | Sergipe | 49100-000 | Brazil |
| Faculdade de Medicina de São José do Rio Preto - FAMERP | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Centro de Pesquisa ClÃnica da Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS | Campo Grande | 79070-900 | Brazil |
| Centro de Estudos do Instituto de Infectologia EmÃlio Ribas | São Paulo | 01246-900 | Brazil |
| Derived |
| Buerger V, Hadl S, Schneider M, Schaden M, Hochreiter R, Bitzer A, Kosulin K, Mader R, Zoihsl O, Pfeiffer A, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Dubischar K, Wressnigg N, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in endemic areas of Brazil: interim results of a double-blind, randomised, placebo-controlled phase 3 trial in adolescents. Lancet Infect Dis. 2025 Jan;25(1):114-125. doi: 10.1016/S1473-3099(24)00458-4. Epub 2024 Sep 5. |
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | Kg/square Meter |
|
| Serostatus (PRNT) | Serostatus result is missing for one participant | Count of Participants | Participants |
|
Placebo
Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
|
|
| Secondary | CHIKV-specific Antibody Titers as GMTs up to 1 Year | Immune response as measured by CHIKV-specific neutralizing antibody titers on Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination as determined by μPRNT | Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50<= 40) were analysed: Active arm N= 251 Placebo arm N=42 | Posted | Mean | 95% Confidence Interval | titer | On study Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination |
|
|
|
| Secondary | Seroprotection up to 1 Year | Percentage of subjects with seroprotective levels defined as μPRNT50 ≥ 150 for μPRNT baseline negative subjects on Day 8, Day 85, Day 180 and Month 12 post-vaccination as determined by μPRNT. | Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50<= 40) were analysed: Active arm N= 251 Placebo arm N=42 | Posted | Count of Participants | Participants | On the study Day 8, Day 85, Day 180, and Day 365 (Month 12) after vaccination |
|
|
|
| Secondary | Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline | Percentage of subjects with seroconversion defined as > 4-fold increase of μPRNT50 compared to baseline at Day 29, Month 6 and Month 12 as determined by μPRNT assay | Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50<= 40) were analysed: Active arm N= 251 Placebo arm N=42 | Posted | Count of Participants | Participants | On study Day 29, Day 180 and Month 12 after vaccination |
|
|
|
| Secondary | Fold Change in Neutralizing Antibodies Compared to Baseline | Fold change of CHIKV-specific neutralizing antibody titers determined by μPRNT assay at Days 8, 29, 85, 180 and at Month 12 post-vaccination as compared to baseline | Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50<= 40) were analysed: Active arm N= 251 Placebo arm N=42 | Posted | Mean | Standard Deviation | fold change | On study Day 8, 29, 85, 180 and Month 12 after vaccination |
|
|
|
| Secondary | X-fold Change in Neutralizing Antibody Titers at Month 12 Compared to Baseline | Percentage of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay | Only participants with no major protocol deviations out of the immunogenicity population (per protocol population) seronegative at baseline (µPRNT50<= 40) were analysed: Active arm N= 251 Placebo arm N=42 | Posted | Count of Participants | Participants | 365 days (12 months) after vaccination |
|
|
|
| Secondary | Immunogenicity (GMT) Per Baseline Serostatus | CHIKV-specific neutralizing antibodies, determined by μPRNT assay at Days 1, 8, 29, 85, 180, and Month 12 post-vaccination stratified by μPRNT baseline serostatus. | Only participants without major protocol deviations out of the immunogenicity population (= per protocol population) seronegative at baseline (µPRNT50<= 40) or seropositive at baseline (μPRNT50>40) were analysed: Active seropositive arm N= 52 Active seronegative arm N=251 | Posted | Geometric Mean | 95% Confidence Interval | Titer | On study Day 1, 8, 29, 85, 180 and Month 12 after vaccination |
|
|
|
| Secondary | Number of Participants With Unsolicited Adverse Events | Frequency of unsolicited AEs at Day 29 and Day 180 (6 months) post-vaccination | Safety Population | Posted | Count of Participants | Participants | On study Day 29 and Day 180 after vaccination |
|
|
|
| Secondary | Number of Participants With Solicited Adverse Events | Frequency of solicited injection site and systemic adverse events within ten days post-vaccination | Safety Population | Posted | Count of Participants | Participants | up to 10 days after vaccination |
|
|
|
| Secondary | Number of Participants With Adverse Event of Special Interest | Frequency of any Adverse Event of Special Interest: The following cluster of symptoms with or without remissions or exacerbations received particular consideration and were defined as early onset AESI:
| Safety population | Posted | Count of Participants | Participants | until 365 days (12 months) after vaccination |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | Frequency and relatedness of any Serious Adverse Event (SAE) during the entire study period | Safety population | Posted | Count of Participants | Participants | until 365 days (12 months) after vaccination |
|
|
|
| 0 |
| 502 |
| 11 |
| 502 |
| 396 |
| 502 |
| EG001 | Placebo | Placebo Placebo: Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo | 0 | 252 | 5 | 252 | 171 | 252 |
|
| Cat scratch disease | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced cat scratch disease, classified as serious due to hospitalization. |
|
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment | Participant experienced fever classified as SAE based on the protocol requirement to report Grade 4 systemic reactions according to the FDA toxicity scale, as serious. No criteria for seriousness were met. |
|
| Appendicitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced acute appendicitis, classified as serious due to hospitalization. |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment | Participant experienced arthropod sting, classified as serious due to hospitalization. |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment | Participant experienced seizure, classified as serious due to hospitalization. |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment | Participant experienced hyperkalemia, classified as SAE based on the protocol requirement to report Grade 4 laboratory findings according to the FDA toxicity scale as serious. No criteria for seriousness were met. |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment | This event of neutropenia was classified as serious based on the protocol requirement to report Grade 4 laboratory findings according to the FDA toxicity scale, as SAEs. No criteria for seriousness were met. |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced gastroenteritis, classified as serious due to hospitalization. |
|
| Juvenile Myoclonic Epilepsy | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment | Participant experienced juvenile myoclonic epilepsy, classified as serious due to hospitalization |
|
| Transaminase increase | Investigations | MedDRA 24.1 | Systematic Assessment | Participant experienced increased transaminases classified as SAE based on the protocol requirement to report Grade 4 laboratory findings according to the FDA toxicity scale as serious. No criteria for seriousness were met. |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 24.1 | Non-systematic Assessment | Participant experienced suicidal ideation, classified as serious due to hospitalization. |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced pneumonia, classified as serious due to hospitalization. |
|
| Dengue fever | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced dengue fever, classified as serious due to hospitalization. |
|
| Prothrombin time prolonged | Investigations | MedDRA 24.1 | Systematic Assessment | Participant experienced prothrombin time prolongation classified as SAE based on the protocol requirement to report Grade 4 laboratory findings according to the FDA toxicity scale as serious. No criteria for seriousness were met. |
|
| Pharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment | Participant experienced pharyngitis, classified as serious due to hospitalization. |
|
|
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment | Including solicited and unsolicited events. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D000096724 |
| Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D014036 | Togaviridae Infections |
| D012327 | RNA Virus Infections |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Day 8 GMT |
|
|
| Day 29 GMT |
|
|
| Day 85 GMT |
|
|
| Day 180 GMT |
|
|
| Month 12 GMT |
|
|
| Non-seroprotected |
|
| Day 85 |
|
|
| Day 180 |
|
|
| Month12 |
|
|
| Non seroconversion |
|
| Day 180 |
|
|
| Month 12 |
|
|
| Day 29 |
|
|
| Day 85 |
|
|
| Day 180 |
|
|
| Month 12 |
|
|
| not reached |
|
| 8-fold change - GMT |
|
|
| 16-fold change - GMT |
|
|
| 64-fold change - GMT |
|
|
| Day 8 |
|
|
| Day 29 |
|
|
| Day 85 |
|
|
| Day 180 |
|
|
| Month 12 |
|
|
| Myalgia (Solicited Systemic AE) |
|
| Fatigue (Solicited Systemic AE) |
|
| Fever (Solicited Systemic AE) |
|
| Nausea (Solicited Systemic AE) |
|
| Arthralgia (Solicited Systemic AE) |
|
| Vomiting (Solicited Systemic AE) |
|
| Rash (Solicited Systemic AE) |
|
| Any solicited injection site adverse event |
|
| Tenderness (Solicited Local AE) |
|
| Pain (Solicited Local AE) |
|
| Induration (Solicited Local AE) |
|
| Redness (Solicited Local AE) |
|
| Swelling (Solicited Local AE) |
|