A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 690
- Primary Endpoint
- Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Study Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants
≥50 years of age in good health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Good health; any underlying chronic illness must be documented to be in stable condition
- •Highly unlikely to conceive through 6 weeks after administration of the study vaccine
Exclusion Criteria
- •Prior administration of any pneumococcal vaccine
- •History of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
- •Known hypersensitivity to any vaccine component
- •Known or suspected impairment of immune function
- •Received systemic corticosteroids for >=14 consecutive days and has not completed treatment <=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
- •Coagulation disorder contraindicating intramuscular vaccination
- •Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
- •Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
- •Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
- •Breast feeding
- •User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Arms & Interventions
V114 Formulation A
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
Intervention: V114-A (Biological)
V114 Formulation B
Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1
Intervention: V114-B (Biological)
Prevnar 13®
Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1
Intervention: Prevnar 13® (Biological)
Outcomes
Primary Outcomes
Percentage of Participants With a Solicited Systemic Adverse Event (AE)
Time Frame: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time Frame: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.
Percentage of Participants With an Adverse Event (AE)
Time Frame: Up to 14 days after vaccination
The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants With a Serious Adverse Event (SAE)
Time Frame: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.
Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
Time Frame: Up to 30 days after vaccination
The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
Time Frame: Day 30 (one month after vaccination)
The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).
Secondary Outcomes
- Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination(Day 30 (one month after vaccination))
- Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)(Baseline and Day 30 (one month after vaccination))
- Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies(Baseline and Day 30 (one month after vaccination))