ClinicalTrials.Veeva

Menu

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: Prevnar 13™
Biological: V114
Biological: PNEUMOVAX™23

Study type

Interventional

Funder types

Industry

Identifiers

NCT03480763
V114-016 (Other Identifier)
2017-004024-30 (EudraCT Number)

Details and patient eligibility

About

This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.

Enrollment

652 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Male or female in good health
  • Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine.

Exclusion Criteria

  • History of invasive pneumococcal disease
  • Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine.
  • Known or suspected impairment of immune function
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Female participant: positive urine or serum pregnancy test
  • Prior administration of any pneumococcal vaccine
  • Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry.
  • Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue [e.g., bursa, tendon steroid injections], and inhaled/nebulized steroids are permitted).
  • Received immunosuppressive therapy
  • Received a blood transfusion or blood products within 6 months of enrollment
  • Participated in another clinical study of an investigational product within 2 months of enrollment
  • Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

652 participants in 2 patient groups

V114
Experimental group
Description:
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)
Treatment:
Biological: PNEUMOVAX™23
Biological: V114
Prevnar 13™
Active Comparator group
Description:
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2)
Treatment:
Biological: PNEUMOVAX™23
Biological: Prevnar 13™

Trial documents
1

Trial contacts and locations

22

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems