Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114-BBiological: Prevnar 13®Biological: V114-A
- Registration Number
- NCT02547649
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 690
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114 Formulation B V114-B Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1 Prevnar 13® Prevnar 13® Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1 V114 Formulation A V114-A Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Solicited Systemic Adverse Event (AE) 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) 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) 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) 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) 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 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 Outcome Measures
Name Time Method Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination Day 30 (one month after vaccination) The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).
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) The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.
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) The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.