Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: V114-B; Biological: Prevnar 13®; Biological: V114-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02547649

V114-006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 690 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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690 participants in 3 patient groups

V114 Formulation A

Experimental group

Description:

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1

Treatment:

Biological: V114-A

V114 Formulation B

Experimental group

Description:

Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1

Treatment:

Biological: V114-B

Prevnar 13®

Active Comparator group

Description:

Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1

Treatment:

Biological: Prevnar 13®