Phase 3
Completed 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)
Source: ClinicalTrials.gov NCT05464420 ↗Enrolled (actual)
2,162
Serious AEs
0.9%
Results posted
May 2024
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
▲ Trending
1citation · ~1 / year
A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4).
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.
Linked Publications
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A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4).
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.