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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 One Year Later in Healthy Adults 50 Years of Age or Older (PNEU-PATH)

NCT03480763•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+3 more criteria

Locations (22)

East Valley Family Physicians ( Site 0104)

Chandler, Arizona, United States

Central Phoenix Medical Clinic, LLC ( Site 0125)

Phoenix, Arizona, United States

Encompass Clinical Research ( Site 0118)

Spring Valley, California, United States

Diablo Clinical Research, Inc ( Site 0132)

Walnut Creek, California, United States

Clinical Research of South Florida ( Site 0126)

Coral Gables, Florida, United States

QPS Miami Research Associates ( Site 0116)

South Miami, Florida, United States

Heartland Research Associates, Llc ( Site 0115)

Wichita, Kansas, United States

Centennial Medical Group ( Site 0109)

Elkridge, Maryland, United States

Rapid Medical Research, Inc. ( Site 0119)

Cleveland, Ohio, United States

University of Texas Medical Branch at Galveston ( Site 0127)

Galveston, Texas, United States

Key Dates

Start Date

June 22, 2018

Primary Completion Date

December 23, 2019

Completion Date

December 23, 2019

Last Updated

November 2, 2021

Enrollment

652

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

V114

BIOLOGICAL

Prevnar 13™

BIOLOGICAL

PNEUMOVAX™23

BIOLOGICAL

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

NCT06998251

Pneumococcal InfectionsRespiratory Syncytial Virus (RSV) Infection+1 more

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NOT_YET_RECRUITINGPHASE4

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

NCT06822907

Acute Febrile IllnessPneumococcal Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage

Immunization To Prevent Acute COPD Exacerbations

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)