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Lack of efficacy
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This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.
Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include the very young, the elderly and immunocompromised individuals. Noroviruses are highly infectious, highly resistant to environmental conditions, and have multiple routes of transmission including person-to-person, food-borne and contaminated surfaces. Noroviruses can cause acute, mild to severe illness characterized by vomiting, diarrhea, fever, dehydration and abdominal pain, representing a significant burden to public health. The clinical presentation in adults and older children is similar. While mortality due to acute gastroenteritis (AGE) caused by norovirus in the pediatric population is rare in industrialized countries, it is more common in developing countries. Although potentially a cause for hospitalization in very young children, there are fewer cases during the first 6 months of life possibly due to the protection offered by maternal antibodies from trans-placental transfer and in breast milk. In addition, norovirus infections have significant socioeconomic impact on hospitals, schools, day care centers and other closed settings. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of AGE in many countries around the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56. |
|
| Experimental | Experimental | One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIL-214 | Biological | 2 injections - given on Day 1 and the second given between Day 29 - Day 57 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated with any (GI or GII) genogroup Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Samples that were positive for GI or GII genogroups were further analyzed for the presence of co-pathogens. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DM Clinical Research | Houston | Texas | 77065 | United States | ||
| Policlinico Social del Norte |
Participants were enrolled in 1 of 2 treatment arms and received 2 doses of either HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide, or placebo.
Participants took part in the primary observation period of the trial (up to Visit 4) at 17 investigative sites in Panama, the Dominican Republic, Honduras, Peru, Columbia, Puerto Rico, and the United States from 28 April 2022 to 28 Dec 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56. |
| FG001 | Experimental | One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2023 | Nov 18, 2024 |
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| Placebo | Biological | 2 injections - given on Day 1 and the second given between Day 29 - Day 57 |
|
| The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | Time to first occurrence during the primary observation period* of moderate/severe AGE case associated with GI.1 or GII.4 norovirus genotypes, irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | Time to first occurrence during the primary observation period of moderate/severe AGE case associated with any norovirus genogroup (GI or GII), irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
| Immunogenicity of HIL-214 Compared to Placebo | The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at up to 56 days post dose 1 (Visit 2), 28 days post dose 2 (Visit 3), and/or at 1 year of age (visit 4) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses | Participant reaches 1 year of age |
| Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) | Percentage of participants with solicited local (injection site) adverse events (AEs) within 7 days of vaccine administration. Assessed AEs include injection site pain, erythema, induration, and swelling. | Up to 7 days after each dose of HIL-214 or placebo. |
| Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) | Percentage of participants with solicited systemic AEs within 7 days of vaccine administration. Assessed AEs include drowsiness, irritability/fussiness, loss of appetite, vomiting, and diarrhea. | Up to 7 days after each dose of HIL-214 or placebo. |
| Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal | Percentage of participants with AEs leading to trial vaccine dose withdrawal. | Up to 28 days after first dose of HIL-214 or placebo. |
| Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal. | Percentage of participants with AEs leading to trial withdrawal. | From Day 1 to end of the trial/early termination. |
| Bogotá |
| Bogota D.C. |
| Colombia |
| Cntro de Estudios en Infectologia Pediatrica (CEIP) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Hospital Pediátrico Dr. Hugo Mendoza | Santo Domingo | Nacional | Dominican Republic |
| Hospital General Regional Marcelino Velez Santana | Santo Domingo | 11102 | Dominican Republic |
| CAIMED - Dominican Center for Clinical Studies | Santo Domingo | Dominican Republic |
| ClÃnica Cruz Jiminian | Santo Domingo | Dominican Republic |
| Fundacion Dominicana de Perinatologia Pro Bebe | Santo Domingo | Dominican Republic |
| Demedica | San Pedro Sula | Honduras |
| INVERIME - Inversiones en Investigación Medica | Tegucigalpa | Honduras |
| Investigación Sin Limite | Tegucigalpa | Honduras |
| CEVAXIN David | David | Chiriquà Province | 00507 | Panama |
| CEVAXIN La Chorrera | La Chorrera | Panama |
| CEVAXIN 24 Decembre | Panama City | 00831 | Panama |
| CEVAXIN Av. México | Panama City | Panama |
| Instituto de Investigacion Nutricional | Lima | 15024 | Peru |
| Clinical Research Puerto Rico | Guayama | Puerto Rico |
| Received Two Vaccinations |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56. |
| BG001 | Experimental | One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Weight not reported for all participants. | Mean | Standard Deviation | kg |
| ||||||||||||||
| Length | Length not reported for all participants. | Mean | Standard Deviation | cm |
| ||||||||||||||
| Head circumference | Head circumference not reported for all participants. | Mean | Standard Deviation | cm |
|
| 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 | To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | Posted | Mean | Standard Deviation | months | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated with any (GI or GII) genogroup Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Samples that were positive for GI or GII genogroups were further analyzed for the presence of co-pathogens. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | Posted | Mean | Standard Deviation | months | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
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| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | Time to first occurrence during the primary observation period* of moderate/severe AGE case associated with GI.1 or GII.4 norovirus genotypes, irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | Posted | Mean | Standard Deviation | months | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
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| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | Time to first occurrence during the primary observation period of moderate/severe AGE case associated with any norovirus genogroup (GI or GII), irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% [1- (λV/λC)], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | Posted | Mean | Standard Deviation | months | The duration of the primary observation period was 6 months starting at 28 days post dose 2. |
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| Secondary | Immunogenicity of HIL-214 Compared to Placebo | The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at up to 56 days post dose 1 (Visit 2), 28 days post dose 2 (Visit 3), and/or at 1 year of age (visit 4) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses | Full-Analysis Set, The FAS will include all subjects who are randomized and received at least 1 dose of HIL-214 or placebo. | Posted | Number | 95% Confidence Interval | percentage of participants | Participant reaches 1 year of age |
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| Secondary | Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) | Percentage of participants with solicited local (injection site) adverse events (AEs) within 7 days of vaccine administration. Assessed AEs include injection site pain, erythema, induration, and swelling. | Safety Analysis Set, all participants who were randomized and received at least 1 dose of trial vaccine (HIL-214 or placebo). | Posted | Number | percentage of participants | Up to 7 days after each dose of HIL-214 or placebo. |
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| Secondary | Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) | Percentage of participants with solicited systemic AEs within 7 days of vaccine administration. Assessed AEs include drowsiness, irritability/fussiness, loss of appetite, vomiting, and diarrhea. | Safety Analysis Set, all participants that received at least 1 dose of HIL-214 or placebo. | Posted | Number | percentage of participants | Up to 7 days after each dose of HIL-214 or placebo. |
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| Secondary | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal | Percentage of participants with AEs leading to trial vaccine dose withdrawal. | Safety Analysis Set; all participants that received at least 1 dose of HIL 214 or placebo. | Posted | Number | percentage of participants | Up to 28 days after first dose of HIL-214 or placebo. |
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| Secondary | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal. | Percentage of participants with AEs leading to trial withdrawal. | Safety Analysis Set; all participants that received at least 1 dose of HIL-214 or placebo. | Posted | Number | percentage of participants | From Day 1 to end of the trial/early termination. |
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Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine.
Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56. | 1 | 1,536 | 165 | 1,536 | 889 | 1,536 |
| EG001 | Experimental | One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56. | 2 | 1,541 | 169 | 1,541 | 902 | 1,541 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency anemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cerebrovascular arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Polydactyly | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sickle cell anemia | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pelvic mass | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sudden infant death syndrome | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Metapneumovirus bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Meningitis herpes | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Exposure via ingestion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Foreign body ingestion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Burns third degree | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Anuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Childhood asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Intestinal anastomosis | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
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| Pelvic venous thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Abscess neck | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Abscess of external ear | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Encephalitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Escherichia urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Infection parasitic | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Parasitic gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Tethered oral tissue | Congenital, familial and genetic disorders | MedDRA 27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Accidental exposure to product by child | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Post-procedural complication | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Cholinergic syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Patient device incompatibility | Product Issues | MedDRA 27.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Astrid Borkowski, Chief Medical Officer | HilleVax, Inc. | +1 (617) 213-6562 | aborkowski@hillevax.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2024 | Nov 18, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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