Clinical trial NCT02547649: Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)
Official title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Pneumococcal Vaccine-Naïve Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 690
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With a Solicited Systemic Adverse Event (AE)
timeFrame: Up to 14 days after vaccination
measure: Percentage of Participants With a Serious Adverse Event (SAE)
timeFrame: Up to 30 days after vaccination
measure: Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)
timeFrame: Up to 30 days after vaccination
measure: Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination
timeFrame: Day 30 (one month after vaccination)
Secondary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination
timeFrame: Day 30 (one month after vaccination)
measure: Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)
timeFrame: Baseline and Day 30 (one month after vaccination)
measure: Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies
timeFrame: Baseline and Day 30 (one month after vaccination)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Hum Vaccin Immunother. 2019;15(3):530-539. doi: 10.1080/21645515.2018.1532249. Epub 2019 Jan 16.