Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HIL-214 · 3 trials · 1 indication
Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.
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.
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.
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.
Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days of Vaccine Administration (any dose). Assessed AEs included pain, erythema, induration, and swelling.
Percentage of Participants with Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Percentage of participants with AEs that lead to withdrawal of trial vaccine up to the planned time of second dose administration.
| Arm | Type | Description |
|---|---|---|
| Open Arm Study | EXPERIMENTAL | One dose given to all participants |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| HIL-214 | BIOLOGICAL | HIL-214 |
| Placebo | BIOLOGICAL | 2 injections - given at 4 months and the second at 6 months of age. |
Inclusion Criteria: * Male or female subjects aged 18 to 49 years, inclusive. * Individuals 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 individual signs and...