A Study of V132 in Healthy Older Participants (V132-001)

Purpose

The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.

Condition

  • Healthy

Eligibility

Eligible Ages
Between 50 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

The key inclusion criteria include but are not limited to the following: - Is in good health - Has body mass index (BMI) within 18.0 to 35.0 kg/m^2 (inclusive)

Exclusion Criteria

The key exclusion criteria include but are not limited to the following: - Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination - Has received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Dose Escalation 		Participants will receive single intramuscular (IM) doses of a V132 formulation or comparator regimen at varying dose levels.
  • Biological: V132 Formulation 1
    Experimental
  • Biological: V132 Formulation 2
    Experimental
  • Biological: V132 Formulation 3
    Experimental
  • Biological: PREVNAR 20™
    Active Comparator
  • Biological: CAPVAXIVE™
    Active Comparator
Experimental
Part 2: Dose Expansion 		Participants will receive single IM doses of a V132 formulation or comparator regimen. Doses will be determined based on review of Part 1 data and will not exceed maximum dose level assessed in Part 1.
  • Biological: V132 Formulation 1
    Experimental
  • Biological: V132 Formulation 2
    Experimental
  • Biological: V132 Formulation 3
    Experimental
  • Biological: PREVNAR 20™
    Active Comparator
  • Biological: CAPVAXIVE™
    Active Comparator

Recruiting Locations

Anaheim Clinical Trials ( Site 0006)
Anaheim, California 92801
Contact:
Study Coordinator
714-774-7777

Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida 33009
Contact:
Study Coordinator
954-455-5757

Research Centers of America ( Hollywood ) ( Site 0009)
Hollywood, Florida 33024
Contact:
Study Coordinator
954-990-7649

QPS-MRA, LLC-Early Phase ( Site 0001)
South Miami, Florida 33143
Contact:
Study Coordinator
305-722-0970

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)
Springfield, Missouri 65802
Contact:
Study Coordinator
417-831-2048

Velocity Clinical Research Lincoln ( Site 0007)
Lincoln, Nebraska 68510
Contact:
Study Coordinator
531-530-2800

Velocity Clinical Research, Omaha ( Site 0008)
Omaha, Nebraska 68134
Contact:
Study Coordinator
402-933-6500

Remington-Davis, Inc. ( Site 0005)
Columbus, Ohio 43215
Contact:
Study Coordinator
614-487-2560

University of Texas Medical Branch ( Site 0004)
League City, Texas 77573
Contact:
Study Coordinator
832-340-2313

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com