Adults 2 Months to 2 Months, any sex, with Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 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 concentr
Anti-poliovirus type 1 neutralizing antibody titers ≥3 log2
Group
Value
95% CI
Placebo (Panama)
100
HIL-214 (Panama)
100
Placebo (USA)
100
HIL-214 (USA)
83.3
Anti-poliovirus type 2 neutralizing antibody titers ≥3 log2
Group
Value
95% CI
Placebo (Panama)
100
HIL-214 (Panama)
100
Placebo (USA)
100
HIL-214 (USA)
100
Anti-poliovirus type 3 neutralizing antibody titers ≥3 log2
Group
Value
95% CI
Placebo (Panama)
99.3
HIL-214 (Panama)
99.2
Placebo (USA)
100
HIL-214 (USA)
100
Anti-PRP IgG concentration ≥ 0.15 ug/mL
Group
Value
95% CI
Placebo (Panama)
100
HIL-214 (Panama)
100
Placebo (USA)
100
HIL-214 (USA)
100
Anti-HBsAg IgG concentration ≥10 mIU/mL
Group
Value
95% CI
Placebo (Panama)
100
HIL-214 (Panama)
100
Placebo (USA)
100
HIL-214 (USA)
100
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.Primary· 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
Anti-pertussis FHA concentration
Group
Value
95% CI
Placebo (Panama)
83.958
± 1.8338
HIL-214 (Panama)
78.726
± 1.8566
Placebo (USA)
32.515
± 2.9346
HIL-214 (USA)
26.358
± 2.7499
Anti-pertactin (PRN) concentration
Group
Value
95% CI
Placebo (Panama)
92.605
± 2.1811
HIL-214 (Panama)
84.617
± 2.2496
Placebo (USA)
61.222
± 2.6526
HIL-214 (USA)
43.417
± 2.7743
Anti-pertussis toxin (PTX) concentration
Group
Value
95% CI
Placebo (Panama)
48.536
± 1.8552
HIL-214 (Panama)
48.906
± 2.0150
Placebo (USA)
80.713
± 2.2249
HIL-214 (USA)
43.066
± 2.5144
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.Primary· 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.
Anti-pneumococcal IgG concentration for serotype 1
Group
Value
95% CI
Placebo
5.255
± 1.9827
HIL-214
5.802
± 2.2008
Anti-pneumococcal IgG concentration for serotype 3
Group
Value
95% CI
Placebo
0.777
± 2.3728
HIL-214
0.747
± 2.2117
Anti-pneumococcal IgG concentration for serotype 4
Group
Value
95% CI
Placebo
2.958
± 1.8468
HIL-214
2.773
± 2.0253
Anti-pneumococcal IgG concentration for serotype 5
Group
Value
95% CI
Placebo
2.378
± 1.9223
HIL-214
2.429
± 1.9277
Anti-pneumococcal IgG concentration for serotype 6A
Group
Value
95% CI
Placebo
7.660
± 2.0384
HIL-214
7.414
± 2.2194
Anti-pneumococcal IgG concentration for serotype 6B
Group
Value
95% CI
Placebo
6.419
± 2.3854
HIL-214
5.459
± 2.7604
Anti-pneumococcal IgG concentration for serotype 7F
Group
Value
95% CI
Placebo
5.091
± 1.6726
HIL-214
5.063
± 1.7727
Anti-pneumococcal IgG concentration for serotype 9V
Group
Value
95% CI
Placebo
3.881
± 1.9259
HIL-214
3.568
± 2.1651
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.Primary· 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.
Group
Value
95% CI
Placebo
67.772
± 4.0633
HIL-214
87.694
± 4.2618
Immunogenicity of a 2-dose Regimen of HIL-214 Co-administered With Routine Pediatric Vaccines at 4 and 6 Months of Age.Secondary· Pre-dose 1 and 28 days post-dose 2
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).
Anti-GI.1 seroresponse by HBGA-blocking assay at 28 days post-dose 2
Group
Value
95% CI
Placebo (Panama)
4.1
1.3 – 9.2
HIL-214 (Panama)
97.5
92.7 – 99.5
Placebo (USA)
0
0.0 – 45.9
HIL-214 (USA)
100
59.0 – 100
Anti-GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2
Group
Value
95% CI
Placebo (Panama)
1.6
0.2 – 5.8
HIL-214 (Panama)
51.3
41.9 – 60.5
Placebo (USA)
0
0.0 – 52.5
HIL-214 (USA)
16.7
0.4 – 64.1
Anti-GI.1 and GII.4c seroresponse by HBGA-blocking assay at 28 days post-dose 2
Group
Value
95% CI
Placebo (Panama)
0.8
0.0 – 4.5
HIL-214 (Panama)
53.0
43.5 – 62.4
Placebo (USA)
0
0.0 – 52.2
HIL-214 (USA)
16.7
0.4 – 64.1
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.Secondary· Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
Percentage of participants with solicited local (injection site) reactions within 7 days of any vaccine administration. Assessed reactions included pain, redness, induration, and swelling.
Group
Value
95% CI
Placebo
38.4
HIL-214
41.2
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.Secondary· Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2
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.
Group
Value
95% CI
Placebo
54.9
HIL-214
46.1
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.Secondary· Day 1 to 28 days post-dose 1 (vaccine discontinuation); Day 1 to 12 months post-dose 1
Percentage of participants with adverse events (AEs) leading to vaccine discontinuation or trial withdrawal.
AE leading to vaccine discontinuation
Group
Value
95% CI
Placebo
0
HIL-214
0
AE leading to trial withdrawal
Group
Value
95% CI
Placebo
0
HIL-214
0
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 PlaceboSecondary· Day 1 to 12 months post-dose 1
Percentage of participants with medically attended adverse events (AEs) at any point during the trial.
Group
Value
95% CI
Placebo
63.4
HIL-214
65.5
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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. This trial will also evaluate the safety profile of a 2-dose regimen of HIL-214 co-administered with routine pediatric vaccines.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06007781 — Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
· Phase 1
· completed
NCT05972733 — Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
· Phase 2
· completed
NCT05281094 — Efficacy and Safety of Two Doses of HIL-214 in Children
· Phase 2, PHASE3
· terminated
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Other HilleVax trials
Trials by the same sponsor.
NCT06007781 — Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
· Phase 1
· completed
NCT05972733 — Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
· Phase 2
· completed
NCT05281094 — Efficacy and Safety of Two Doses of HIL-214 in Children
· Phase 2, PHASE3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HilleVax
Last refreshed: 12 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05836012.