Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: Prevnar 13™; Biological: V114

Study type: Interventional

Funder types: Industry

Identifiers

NCT02573181

V114-007 (Other Identifier)

Details and patient eligibility

About

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Enrollment: 253 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is in good health (any underlying chronic illness must be documented to be in stable condition)
• Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
• Is a male or postmenopausal female

Exclusion criteria

• Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
• Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
• Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
• Is known or suspected impairment of immune function
• Has 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
• Has a 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
• Has 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
• Has 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
• Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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253 participants in 2 patient groups

V114

Experimental group

Description:

Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1.

Treatment:

Biological: V114

Prevnar 13™

Active Comparator group

Description:

Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.

Treatment:

Biological: Prevnar 13™