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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)

ClinicalTrials.gov Identifier: NCT05464420 (view full study on clinicaltrials.gov)
Condition:  Pneumococcal Disease
Status:  Completed


Official Title: A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

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.

Interventional
Phase 3
2162
August 2022
May 2023
May 2023
18 years to 49 years
All
Yes


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

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