A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Pneumonia, Pneumococcal

Treatments: Biological: V116; Biological: QIV; Biological: Matching Placebo for V116

Study type: Interventional

Funder types: Industry

Identifiers

NCT05526716

V116-005

Details and patient eligibility

About

This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.

Enrollment: 1,080 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
• Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent

Exclusion criteria

• History of IPD or other culture-positive pneumococcal disease
• Known or suspected impairment of immunological function
• Receipt of systemic corticosteroids or immunosuppressive therapy
• Received any pneumococcal vaccine <12 months prior to enrollment
• Prior administration of PCV15 or PCV20
• Received any influenza vaccine <6 months prior to enrollment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,080 participants in 2 patient groups

Concomitant group (V116 + QIV followed by placebo)

Experimental group

Description:

Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 and a single 0.5 mL IM injection of QIV on Day 1 and a single 0.5 mL injection of placebo on Day 30

Treatment:

Biological: Matching Placebo for V116

Biological: QIV

Biological: V116

Sequential group (placebo + QIV followed by V116)

Experimental group

Description:

Participants will receive a single 0.5 mL IM injection of QIV and a single 0.5 mL IM injection of placebo on Day 1 and a single 0.5 mL injection of V116 on Day 30

Treatment:

Biological: Matching Placebo for V116

Biological: QIV

Biological: V116