GastroenteritisPhase 2/3NCT05836012

Safety and Immunogenicity of HIL-214 With Routine Pediatric Vaccines

A Phase 2/3 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a phase 2, multi-country, randomized, double-blind, placebo-controlled trial to evaluate the immune response to routine pediatric vaccinations when co-administered with HIL-214 or placebo in healthy infants. Read more about this study

Who is it for?: Ages 2 to 2 monthsHealthy volunteers can take part
Conditions the study is for: Gastroenteritis
What is being tested?: HIL-214
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 329 participants
Where: 12 sitesin 3 countries
Study dates: 10 Jun 2023to 8 Jul 2024
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 2 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

The subject is aged 2 months (+14 days).
Male or female.
Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Infants whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up.

Who cannot join

Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines).
Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients).
Severe reaction to routine childhood vaccine(s) administered at Visit 1.
Any clinically significant active infection (as assessed by the investigator) or temperature
≥38.0°C (>100.4°F), within 3 days of intended trial vaccination.

Show all 14Show fewer

Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease).
Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial.
Known or suspected impairment/alteration of immune function.
Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Subjects who received or are scheduled to receive any licensed or authorized vaccines not planned in this trial within 14 days (for inactivated vaccines) or within 28 days (for live vaccines) before or after any dose of trial vaccine. Note: Flu and/or COVID vaccine can be administered per local guidelines at any time during the trial.
Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or due to participate in another clinical trial at any time during the conduct of this trial.
Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection.
Subject's LAR or subject's first-degree relatives involved in the trial conduct.

Trial locations and contacts

12 sites in 3 countries.

Country

City, postcode or hospital

12 sites in 3 countries

United States7 sites

Velocity Clinical Research - Hastings
Hastings, Nebraska, 68901
La Providence Pediatrics Clinic - Chemidox Clinical Trials (Hypercore)
Houston, Texas, 77071
Alliance for Multispecialty Research LLC - Kaysville
Kaysville, Utah, 84037
Velocity Clinical Research - Lafayette
Lafayette, Louisiana, 70508
Frontier Pediatric Care
Lincoln, Nebraska, 68516
Boeson Research MSO
Missoula, Montana, 59804
Alliance for Multispecialty Research LLC - Syracuse
Syracuse, Utah, 84075

Other trials in United States

Panama3 sites

CEVAXIN-La Chorrera
La Chorrera
Cervaxin-Avenida Mexico
Panama City
Cervaxin-Tocumen
Panama City

Other trials in Panama

Puerto Rico2 sites

BRCR Global
San Juan, 00907
HACTR
San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Multi-country, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Safety and Immunogenicity When HIL-214 is Concomitantly Administered With Routine Pediatric Vaccines in Healthy Infants

Read the detailed description

Epidemiologic studies have shown that gastroenteritis in infants is associated with several viruses, including norovirus, sapovirus and rotavirus. These viruses together or individually can be associated with illness ranging from asymptomatic to serious. Asymptomatic infection can create a reservoir, allowing further spread of the virus, whereas serious illness can lead to death, particularly in the very young, very old or immunocompromised. 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 acute gastroenteritis (AGE) in many countries around the world. Currently, there is no available vaccine to counter the disease burden associated with norovirus. Vaccinating at an early age would reduce the severe illness in young children and also reduce the asymptomatic cases which act as a vehicle for transmission within the population. As infants already receive multiple vaccines during the first months of life, an additional vaccination must fit into the immunization scheme in a convenient way for compliance. It must also have an acceptable safety profile and be immunogenic without interfering with the immune response to routine childhood vaccines.

Conditions: Gastroenteritis
Being tested: HIL-214, Placebo
Medical subject headings: Gastroenteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIL-214Biological
2 injections - given at 4 months and the second at 6 months of age.
PlaceboBiological
2 injections - given at 4 months and the second at 6 months of age.

Study groups in NCT05836012
Study group	Role	What they receive
Experimental	Experimental	HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule. Receives: Biological: HIL-214
Placebo	Placebo comparator	Placebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA).
Outcome measures:
- Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL.
- Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL.
- Anti-pertussis [FHA], [PRN] and [PTX]) IgG concentrations.
- Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8,
- Binary variable indicating anti-Haemophilus influenzae type b
- Binary variable indicating anti-hepatitis b surface antigen
Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Measured: 28 days post-dose 2
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA).
Outcome measures:
Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
Measured: 28 days post-dose 2
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG [serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F]) at 28 days post-dose. Geometric mean concentrations are presented.
Measured: 28 days post-dose 2
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.
Measured: 28 days post-dose 2

Secondary outcomes (5)

Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Anti-norovirus (GI.1 and GII.4c) HBGA-blocking antibodies were measured at prior to dose 1 (~4 months of age) and 28 days post-dose 2 (~6 months of age). Seroresponse was defined as a fold increase from baseline greater than or equal to 4. Seroresponse rates and 95% confidence intervals (CIs) are presented. Data are stratified by country (Panama and USA).
Measured: Pre-dose 1 and 28 days post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
Measured: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with solicited systemic adverse events (AEs) within 7 days of any vaccine administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Measured: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
Measured: Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Measured: Day 1 to 12 months post-dose 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 20238 Jul 2024

First posted1 May 2023
Study start10 Jun 2023
Primary completion19 Jan 2024
Study completion8 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastroenteritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05836012
Sponsor's protocol ID: NOR-206
Status last verified: Dec 2024
First submitted: 21 Mar 2023
Last updated: 12 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroenteritis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multi-country, Randomized, Double-blind, Placebo-controlled Trial to Evaluate Safety and Immunogenicity When HIL-214 is Concomitantly Administered With Routine Pediatric Vaccines in Healthy Infants
ClinicalTrials.gov ID: NCT05836012
Acronym / sponsor ID: NOR-206
Conditions: Gastroenteritis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 329 participants (actual)
Lead sponsor: HilleVaxIndustry (pharma, biotech, devices)
Study start: 10 Jun 2023 (actual)
Primary completion: 19 Jan 2024 (actual)
Study completion: 8 Jul 2024 (actual)
First posted: 1 May 2023 (actual)
Results: Posted 12 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Biological: HIL-214HIL-214 (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.
Placebo	Placebo comparator	Biological: PlaceboPlacebo (1 dose at 4 months of age and 1 dose at 6 months of age) and routine childhood vaccines according to schedule.

Who may qualify

Ages: 2 to 2 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

The subject is aged 2 months (+14 days).
Male or female.
Infants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Infants whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up.

Key exclusion criteria (14 listed)

Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines).
Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination.
Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients).
Severe reaction to routine childhood vaccine(s) administered at Visit 1.
Any clinically significant active infection (as assessed by the investigator) or temperature

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HIL-2142 injections - given at 4 months and the second at 6 months of age.	Biological	Experimental
Placebo2 injections - given at 4 months and the second at 6 months of age.	Biological	Placebo

Primary outcome

Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: 28 days post-dose 2
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: * Binary (yes/no) variable indicating anti-DT immunoglobulin G (IgG) concentration ≥0.1 IU/mL. * Binary variable indicating anti-TT IgG concentration ≥0.1 IU/mL. * Anti-pertussis [FHA], [PRN] and [PTX]) IgG concentrations. * Binary variable indicating anti-poliovirus neutralizing antibody titers ≥1:8, * Binary variable indicating anti-Haemophilus influenzae type b * Binary variable indicating anti-hepatitis b surface antigen Geometric mean (geometric mean standard deviation) anti-FHA, anti-PRN, and anti-PTX are presented as a separate outcome.
Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: 28 days post-dose 2
Evaluate the immune response to the licensed pediatric DTaP-Hib-IPV-HepB vaccine co-administered with a 2-dose regimen of HIL-214 at 4 and 6 months of age, compared to that of the routine pediatric vaccine co-administered with placebo. Due to differing local availability of licensed DTaP-Hib-IPV-HepB vaccine, data are presented by country (Panama and USA). Outcome measures: Geometric mean anti-FHA, anti-PRN, and anti-PTX concentrations
Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: 28 days post-dose 2
The outcome was assessed using measurements of immune response to the concomitant anti-pneumococcal capsular polysaccharide IgG [serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 18C, and 23F]) at 28 days post-dose. Geometric mean concentrations are presented.
Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: 28 days post-dose 2
This outcome was assessed using measurements of immune response to the concomitant RV1 vaccine (anti-RV1 IgA). Geometric mean concentrations at 28 days post-dose 2 are reported.

5 secondary outcomes

Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.
Time frame: Pre-dose 1 and 28 days post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.
Time frame: Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1
Evaluate the Safety Profile of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo
Time frame: Day 1 to 12 months post-dose 1

Results and safety

Results posted to the registry on 12 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	164	160
HIL-214	165	161

Primary outcome: Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.

Time frame: 28 days post-dose 2. Number. Unit: percentage of participants

Measure	Placebo (Panama) n = 147	HIL-214 (Panama) n = 139	Placebo (USA) n = 9	HIL-214 (USA) n = 9
Anti-diphtheria toxoid IgG concentration ≥0.1 IU/mL.	99.3	100	100	100
Anti-tetanus toxoid IgG concentration ≥0.1 IU/mL	100	100	100	100
Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2	100	100	100	83.3
Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2	100	100	100	100
Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2	99.3	99.2	100	100
Anti-PRP IgG concentration ≥ 0.15 ug/mL	100	100	100	100
Anti-HBsAg IgG concentration ≥10 mIU/mL	100	100	100	100

Population analysed: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that received all doses of all study vaccines (routine and trial vaccines) within the required time window.

Primary outcome: Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.

Time frame: 28 days post-dose 2. Geometric mean (Standard Deviation). Unit: IU/mL

Measure	Placebo (Panama) n = 147	HIL-214 (Panama) n = 139	Placebo (USA) n = 9	HIL-214 (USA) n = 9
Anti-pertussis FHA concentration	83.958 (1.8338)	78.726 (1.8566)	32.515 (2.9346)	26.358 (2.7499)
Anti-pertactin (PRN) concentration	92.605 (2.1811)	84.617 (2.2496)	61.222 (2.6526)	43.417 (2.7743)
Anti-pertussis toxin (PTX) concentration	48.536 (1.8552)	48.906 (2.0150)	80.713 (2.2249)	43.066 (2.5144)

Population analysed: Immunology Evaluable Analysis Set; all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window.

Primary outcome: Immune Response to the Licensed Pediatric Pneumococcal 13 Valent (PCV13) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.

Time frame: 28 days post-dose 2. Geometric mean (Standard Deviation). Unit: ug/mL

Measure	Placebo n = 154	HIL-214 n = 143
Anti-pneumococcal IgG concentration for serotype 1	5.255 (1.9827)	5.802 (2.2008)
Anti-pneumococcal IgG concentration for serotype 3	0.777 (2.3728)	0.747 (2.2117)
Anti-pneumococcal IgG concentration for serotype 4	2.958 (1.8468)	2.773 (2.0253)
Anti-pneumococcal IgG concentration for serotype 5	2.378 (1.9223)	2.429 (1.9277)
Anti-pneumococcal IgG concentration for serotype 6A	7.660 (2.0384)	7.414 (2.2194)
Anti-pneumococcal IgG concentration for serotype 6B	6.419 (2.3854)	5.459 (2.7604)
Anti-pneumococcal IgG concentration for serotype 7F	5.091 (1.6726)	5.063 (1.7727)
Anti-pneumococcal IgG concentration for serotype 9V	3.881 (1.9259)	3.568 (2.1651)

Primary outcome: Immune Response to the Licensed Pediatric Rotavirus Vaccine (RV1) Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo.

Time frame: 28 days post-dose 2. Geometric mean (Standard Deviation). Unit: U/mL

Measure	Placebo n = 155	HIL-214 n = 147
Value	67.772 (4.0633)	87.694 (4.2618)

Population analysed: Immunology Evaluable Analysis Set, all participants in the randomized analysis set that receive all doses of all study vaccines (routine and trial vaccines) within the required time window

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were assessed from Day 1 to 12 months post-dose 1; unsolicited adverse events were assessed for up to 28 days post-dose 1 and 28 days post-dose 2.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	7 of 164 (4.3%)	81 of 164 (49.4%)	0 of 164
HIL-214	3 of 165 (1.8%)	77 of 165 (46.7%)	0 of 165

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing HIL-214 in people with Gastroenteritis, run by HilleVax at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Panama, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune Response to the Licensed Pediatric DTaP-Hib-IPV-HepB Vaccine Co-administered With a 2-dose Regimen of HIL-214 at 4 and 6 Months of Age, Compared to That of the Routine Pediatric Vaccines Co-administered With Placebo. (time frame: 28 days post-dose 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.