The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: Pneumococcal Conjugate Vaccine (V114); Biological: PREVNAR 13®; Biological: PNEUMOVAX® 23

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513551

2011-004542-18 (Other Identifier)

V114-002 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.

The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

Enrollment: 692 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Without fever for 72 hours prior to vaccination

Exclusion criteria

• Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
• Known or suspected to be immunocompromised
• Functional or anatomic asplenia
• History of autoimmune disease
• Evidence of dementia or cognitive impairment
• Use of any immunosuppressive therapy
• Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
• Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
• Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
• Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
• History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
• Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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692 participants in 3 patient groups

V114

Experimental group

Description:

Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Treatment:

Biological: Pneumococcal Conjugate Vaccine (V114)

PNEUMOVAX® 23

Active Comparator group

Description:

Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.

Treatment:

Biological: PNEUMOVAX® 23

PREVNAR 13®

Active Comparator group

Description:

Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.

Treatment:

Biological: PREVNAR 13®