Phase 3
N=2,162
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05464420 ↗Enrolled (actual)
2,162
Serious AEs
0.9%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots — 13.4; 14.2; 13.1; 72.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V116 (Biological); PPSV23 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots |
13.4; 14.2; 13.1; 72.9; 72.9; 73.9 | — |
| PRIMARY Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23 |
13.6; 7.6; 73.3; 60.6; 13.2; 7.6 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots |
38.0; 34.0; 34.4; 28.0; 26.1; 27.5 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23 |
35.5; 34.0; 27.2; 21.4; 16.3; 8.7 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots |
0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23 |
0.0; 0.0 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
327.2; 299.0; 318.8; 6901.9; 6014.9; 6641.2 | <0.001 sig |
| SECONDARY GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 |
316.5; 339.8; 6491.7; 1866.4; 6702.2; 5058.1 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
0.83; 0.85; 0.87; 5.94; 5.29; 5.84 | — |
| SECONDARY GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23 |
0.85; 0.77; 5.67; 1.45; 5.19; 3.36 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
8.2; 8.1; 8.2; 46.8; 37.8; 35.8 | — |
| SECONDARY Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
70.7; 71.0; 70.6; 87.2; 86.5; 85.6 | — |
| SECONDARY GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
4.4; 4.7; 4.6; 21.2; 18.8; 21.0 | — |
| SECONDARY Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots |
51.8; 54.4; 52.0; 87.8; 85.3; 89.3 | — |
| SECONDARY GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots |
6849.6; 6009.2; 6724.3; 3972.7; 3421.5; 3750.9 | — |
Summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Eligibility Criteria
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Has underlying chronic conditions but assessed to be stable as per investigator
- Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Exclusion Criteria
- Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
- Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccination
- Has a recent illness with fever
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- Is expected to receive any pneumococcal vaccine during the study outside of the protocol
- Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
- Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
- Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
Data sourced from ClinicalTrials.gov (NCT05464420). 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.