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)

Phase 2

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: PNEUMOVAX® 23; Biological: PREVNAR 13®; Biological: Pneumococcal Conjugate Vaccine (V114)

• Registration Number: NCT01513551
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2012-01-16
• Study First Posted: 2012-01-20
• Study Start: 2012-03-13
• Primary Completion: 2013-02-15
• Study Completion: 2013-02-15
• Status Verified: 2018-11
• Results First Submitted: 2018-11-26
• Results First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Results First Posted: 2018-12-13
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 692

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNEUMOVAX® 23	PNEUMOVAX® 23	Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1.
PREVNAR 13®	PREVNAR 13®	Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1.
V114	Pneumococcal Conjugate Vaccine (V114)	Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Adverse Event	All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination	An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies	One month postvaccination	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.
Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups	Up to Day 14 postvaccination	Systemic AEs reported by \>=2% of participants in one or more vaccination groups were assessed.
Percentage of Participants With a Serious Adverse Event	Up to 6 months postvaccination	A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Percentage of Participants With a Vaccine-related Serious Adverse Event	Up to 6 months postvaccination	A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.
Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups	Up to Day 14 postvaccination	Injection-site AEs reported by \>=2% of participants in one or more vaccination groups were assessed.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies	One month postvaccination	OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)