Clinical trial NCT01513551: 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)
Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of a Pneumococcal Conjugate Vaccine (V114) Compared to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and PREVNAR 13® (Pneumococcal 13-Valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in Healthy Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Keywords: Pneumococcal vaccines
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 692
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With an Adverse Event
timeFrame: All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination
measure: Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
timeFrame: Up to Day 14 postvaccination
measure: Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups
timeFrame: Up to Day 14 postvaccination
measure: Percentage of Participants With a Serious Adverse Event
timeFrame: Up to 6 months postvaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event
timeFrame: Up to 6 months postvaccination
measure: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies
timeFrame: One month postvaccination
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies
timeFrame: One month postvaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17.