Phase 3
N=58
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04633226 ↗Enrolled (actual)
58
Serious AEs
7.0%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Participants With ≥1 Solicited Injection-site Adverse Events — 54.4; 57.9; 50.9; 59.6 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V114 (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥1 Solicited Injection-site Adverse Events |
54.4; 57.9; 50.9; 59.6 | — |
| PRIMARY Percentage of Participants With ≥1 Solicited Systemic Adverse Events |
71.9; 89.5; 82.5; 8.8 | — |
| PRIMARY Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events |
0.0 | — |
| PRIMARY Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event |
0.0 | — |
| PRIMARY Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL |
100.0; 100.0; 100.0; 100.0; 100.0; 95.7 | — |
| PRIMARY Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3 |
1.69; 1.70; 1.87; 2.14; 2.16; 2.53 | — |
| SECONDARY Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4 |
2.24; 1.32; 1.86; 3.27; 5.77; 6.80 | — |
Summary
The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.
Eligibility Criteria
Inclusion Criteria
- is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
- has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent
Exclusion Criteria
- has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
- has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
- has had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) within 72 hours prior to receipt of study vaccine
- has known or suspected impairment of immunological function
- has or his/her mother has human immunodeficiency virus (HIV) infection
- has or his/her mother has hepatitis B surface antigen-positive test
- has known or history of functional or anatomic asplenia
- has a history of autoimmune disease
- has a history or suspected history of neurological disorder
- has received a pneumococcal vaccine prior to study entry
- has received, or is anticipated to need, corticosteroid therapy
- has received a blood transfusion of immunoglobulin products
- has participated in another clinical study of an investigational product
Data sourced from ClinicalTrials.gov (NCT04633226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.