A Phase 2/3 interventional study of HIL-214 and Placebo in Gastroenteritis, sponsored by HilleVax. Terminated at 17 sites in 7 countries. Open to participants aged 5 Months to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by HilleVax (part of Ligand Pharmaceuticals Incorporated) · Phase 2/3, Interventional, and Prevention
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.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 3,084 is above the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →HilleVax is the lead sponsor of 4 studies on the registry; none are open to participants now.
First submitted before HilleVax became part of Ligand Pharmaceuticals Incorporated.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.
Biological: Placebo
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.
Biological: HIL-214
2 injections - given on Day 1 and the second given between Day 29 - Day 57
2 injections - given on Day 1 and the second given between Day 29 - Day 57
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.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to end of the trial/early termination.
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.
| Milestone | Placebo | Experimental |
|---|---|---|
| Started | 1542 | 1542 |
| Received two vaccinations | 1399 | 1425 |
| Completed | 1381 | 1410 |
| Not completed | 161 | 132 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 29 | 22 |
| Withdrew: Withdrawal by legally authorized representative | 122 | 103 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Not pre-specified reason | 8 | 5 |
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.
| months | Placebo | Experimental |
|---|---|---|
| To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | 3.07 ± 2.059 | 3.29 ± 1.746 |
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.
| months | Placebo | Experimental |
|---|---|---|
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | 3.16 ± 1.886 | 3.32 ± 1.519 |
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.
| months | Placebo | Experimental |
|---|---|---|
| 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. | 3.11 ± 1.981 | 3.29 ± 1.628 |
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.
| months | Placebo | Experimental |
|---|---|---|
| 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 | 3.19 ± 1.852 | 3.17 ± 1.541 |
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
| percentage of participants | Placebo | Experimental |
|---|---|---|
| Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2 | 0.6 (0.3 to 1.2) | 36.8 (34.3 to 39.4) |
| Anti-GI.1 HBGA-blocking seroresponse rate at Visit 3 | 1.4 (0.8 to 2.1) | 95.5 (94.3 to 96.6) |
| Anti-GI.1 HBGA-blocking seroresponse rate at Visit 4 | 1.6 (1.0 to 2.4) | 86.2 (84.3 to 88.0) |
| Anti-GII.4c HBGA-blocking seroresponse rate at Visit 2 | 1.3 (0.8 to 2.1) | 7.4 (6.1 to 8.9) |
| Anti- GII.4c HBGA-blocking seroresponse rate at Visit 3 | 2.2 (1.5 to 3.2) | 43.0 (40.4 to 45.6) |
| Anti- GII.4c HBGA-blocking seroresponse rate at Visit 4 | 6.2 (5.0 to 7.6) | 25.0 (22.8 to 27.4) |
| Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 2 | 0 (0.0 to 0.3) | 4.8 (3.7 to 6.0) |
| Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 3 | 0.3 (0.1 to 0.7) | 42.3 (39.7 to 44.9) |
| Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 4 | 0.2 (0.0 to 0.6) | 22.9 (20.7 to 25.2) |
| Anti-GI.1 pan-Ig seroresponse rate at Visit 2 | 1.3 (0.8 to 2.1) | 84.6 (82.6 to 86.4) |
| Anti-GI.1 pan-Ig seroresponse rate at Visit 3 | 2.4 (1.6 to 3.3) | 98.9 (98.3 to 99.4) |
| Anti-GI.1 pan-Ig seroresponse rate at Visit 4 | 8.7 (7.2 to 10.3) | 97.1 (96.0 to 97.9) |
| Anti-GII.4c pan-Ig seroresponse rate at Visit 2 | 3.3 (2.5 to 4.4) | 37.9 (35.4 to 40.5) |
| Anti-GII.4c pan-Ig seroresponse rate at Visit 3 | 8.1 (6.7 to 9.7) | 83.9 (81.9 to 85.8) |
| Anti-GII.4c pan-Ig seroresponse rate at Visit 4 | 23.6 (21.4 to 26.0) | 75.5 (73.1 to 77.7) |
| Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 2 | 0.3 (0.1 to 0.7) | 35.9 (33.4 to 38.4) |
| Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 3 | 1.0 (0.6 to 1.7) | 83.5 (81.4 to 85.4) |
| Anti- GI.1 and GII.4c pan-Ig seroresponse rate at Visit 4 | 4.7 (3.7 to 6.0) | 74.7 (72.3 to 76.9) |
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.
| percentage of participants | Placebo | Experimental |
|---|---|---|
| Any solicited local AE | 6.7 | 10.4 |
| Injection site pain | 5.4 | 8.2 |
| Erythema | 1.8 | 2.0 |
| Induration | 0 | 0.7 |
| Swelling | 0.1 | 0.5 |
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.
| percentage of participants | Placebo | Experimental |
|---|---|---|
| Any solicited systemic AE | 35.2 | 37.7 |
| Drowsiness | 10.7 | 12.7 |
| Irritability/fussiness | 18.0 | 20.2 |
| Loss of appetite | 7.9 | 8.4 |
| Vomiting | 7.4 | 8.6 |
| Diarrhea | 14.6 | 15.4 |
Percentage of participants with AEs leading to trial vaccine dose withdrawal.
| percentage of participants | Placebo | Experimental |
|---|---|---|
| Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal | 0 | 0.1 |
Percentage of participants with AEs leading to trial withdrawal.
| percentage of participants | Placebo | Experimental |
|---|---|---|
| Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal. | 0.1 | 0.1 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 1/1,536 (0.1%) | 165/1,536 (10.7%) | 889/1,536 (57.9%) |
| Experimental | 2/1,541 (0.1%) | 169/1,541 (11%) | 902/1,541 (58.5%) |
| Event | Placebo | Experimental |
|---|---|---|
| PneumoniaInfections and infestations | 46/1536 | 55/1541 |
| BronchiolitisInfections and infestations | 23/1536 | 35/1541 |
| GastroenteritisInfections and infestations | 11/1536 | 11/1541 |
| DehydrationMetabolism and nutrition disorders | 11/1536 | 6/1541 |
| Burns second degreeInjury, poisoning and procedural complications | 6/1536 | 2/1541 |
| Febrile convulsionNervous system disorders | 6/1536 | 4/1541 |
| Pneumonia viralInfections and infestations | 5/1536 | 5/1541 |
| Abscess limbInfections and infestations | 5/1536 | 3/1541 |
| WheezingRespiratory, thoracic and mediastinal disorders | 5/1536 | 5/1541 |
| Amoebic dysenteryInfections and infestations | 2/1536 | 5/1541 |
| Event | Placebo | Experimental |
|---|---|---|
| NasopharyngitisInfections and infestations | 474/1536 | 492/1541 |
| GastroenteritisInfections and infestations | 268/1536 | 285/1541 |
| Upper respiratory tract infectionInfections and infestations | 75/1536 | 69/1541 |
| Dermatitis diaperSkin and subcutaneous tissue disorders | 55/1536 | 64/1541 |
| BronchiolitisInfections and infestations | 39/1536 | 47/1541 |
| DiarrheaGastrointestinal disorders | 40/1536 | 31/1541 |
| AnemiaBlood and lymphatic system disorders | 30/1536 | 23/1541 |
Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.
| Age, Continuous(months) | Placebo | Experimental | Total |
|---|---|---|---|
| Mean | 4.94 ± 0.295 | 4.95 ± 0.291 | 4.95 ± 0.293 |
| Sex: Female, Male(Participants) | Placebo | Experimental | Total |
|---|---|---|---|
| Female | 723 | 725 | 1448 |
| Male | 676 | 700 | 1376 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Experimental | Total |
|---|---|---|---|
| Hispanic or Latino | 1383 | 1407 | 2790 |
| Not Hispanic or Latino | 3 | 5 | 8 |
| Unknown or Not Reported | 13 | 13 | 26 |
| Race/Ethnicity, Customized(Participants) | Placebo | Experimental | Total |
|---|---|---|---|
| Race — American Indian or Alaskan Native | 1 | 0 | 1 |
| Race — Asian | 0 | 1 | 1 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 14 | 9 | 23 |
| Race — White | 3 | 1 | 4 |
| Race — Other | 1302 | 1327 | 2629 |
| Race — More than one race | 11 | 9 | 20 |
| Race — Not Reported | 53 | 64 | 117 |
| Race — Unknown | 15 | 14 | 29 |
| Region of Enrollment(participants) | Placebo | Experimental | Total |
|---|---|---|---|
| Colombia | 44 | 42 | 86 |
| Puerto Rico | 1 | 1 | 2 |
| United States | 1 | 1 | 2 |
| Panama | 764 | 769 | 1533 |
| Dominican Republic | 273 | 284 | 557 |
| Honduras | 221 | 233 | 454 |
| Peru | 95 | 95 | 190 |
| Weight(kg) | Placebo | Experimental | Total |
|---|---|---|---|
| Mean | 7.423 ± 0.9861 | 7.395 ± 0.9979 | 7.409 ± 0.9920 |
| Length(cm) | Placebo | Experimental | Total |
|---|---|---|---|
| Mean | 64.16 ± 2.657 | 64.05 ± 2.731 | 64.10 ± 2.694 |
| Head circumference(cm) | Placebo | Experimental | Total |
|---|---|---|---|
| Mean | 42.08 ± 1.316 | 42.06 ± 1.292 | 42.07 ± 1.304 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: HIL-214