Clinical trial NCT02573181: Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)
Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-10-09
Enrollment: 253
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Up to Day 44 after vaccination
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to Day 5 after vaccination
measure: Percentage of Participants With a Solicited Systemic Adverse Event (AE)
timeFrame: Up to Day 14 after vaccination
measure: Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
measure: Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
measure: Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
measure: Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)
timeFrame: Baseline (Day 1) and Day 30 after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults >/=65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14.