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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)

NCT ID: NCT03480763

Last Updated: 2021-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

652 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-22

Study Completion Date

2019-12-23

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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V114

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)

Group Type EXPERIMENTAL

V114

Intervention Type BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

PNEUMOVAX™23

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Prevnar 13™

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)

Group Type ACTIVE_COMPARATOR

Prevnar 13™

Intervention Type BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose

PNEUMOVAX™23

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Interventions

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V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

Intervention Type BIOLOGICAL

Prevnar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose

Intervention Type BIOLOGICAL

PNEUMOVAX™23

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Intervention Type BIOLOGICAL

Other Intervention Names

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PCV13 PPV23

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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East Valley Family Physicians ( Site 0104)

Chandler, Arizona, United States

Site Status

Central Phoenix Medical Clinic, LLC ( Site 0125)

Phoenix, Arizona, United States

Site Status

Encompass Clinical Research ( Site 0118)

Spring Valley, California, United States

Site Status

Diablo Clinical Research, Inc ( Site 0132)

Walnut Creek, California, United States

Site Status

Clinical Research of South Florida ( Site 0126)

Coral Gables, Florida, United States

Site Status

QPS Miami Research Associates ( Site 0116)

South Miami, Florida, United States

Site Status

Heartland Research Associates, Llc ( Site 0115)

Wichita, Kansas, United States

Site Status

Centennial Medical Group ( Site 0109)

Elkridge, Maryland, United States

Site Status

Rapid Medical Research, Inc. ( Site 0119)

Cleveland, Ohio, United States

Site Status

University of Texas Medical Branch at Galveston ( Site 0127)

Galveston, Texas, United States

Site Status

Texas Center For Drug Development ( Site 0107)

Houston, Texas, United States

Site Status

Diagnostics Research Group ( Site 0100)

San Antonio, Texas, United States

Site Status

J Lewis Research Inc / Foothill Family Clinic ( Site 0123)

Salt Lake City, Utah, United States

Site Status

J Lewis Research Inc/Jordan River Family Medicine ( Site 0114)

South Jordan, Utah, United States

Site Status

Health Research of Hampton Roads, Inc. ( Site 0106)

Newport News, Virginia, United States

Site Status

Seoul National University Hospital ( Site 0400)

Seoul, , South Korea

Site Status

Korea University Guro Hospital ( Site 0401)

Seoul, , South Korea

Site Status

CAP Centelles ( Site 0303)

Centelles, Barcelona, Spain

Site Status

Instituto de Ciencias Medicas.ICM ( Site 0301)

Alicante, , Spain

Site Status

Fundacion Oftalmologica del Mediterraneo ( Site 0300)

Valencia, , Spain

Site Status

National Cheng Kung University Hospital ( Site 0502)

Dawan, , Taiwan

Site Status

National Taiwan University Hospital ( Site 0500)

Taipei, , Taiwan

Site Status

Countries

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United States South Korea Spain Taiwan

References

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Song JY, Chang CJ, Andrews C, Diez-Domingo J, Oh MD, Dagan R, Hartzel J, Pedley A, Li J, Sterling T, Tamms G, Chiarappa JA, Lutkiewicz J, Musey L, Tu Y, Buchwald UK; V114-016 (PNEU-PATH) study group. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged >/=50 years: A randomized phase III trial (PNEU-PATH). Vaccine. 2021 Oct 15;39(43):6422-6436. doi: 10.1016/j.vaccine.2021.08.038. Epub 2021 Sep 4.

Reference Type RESULT
PMID: 34489128 (View on PubMed)

Huang L, Yang X, Li H, Xie Z, Zhu T, You W, Wang Z, Tan J, Feng G, Sun Q, Wang B, Han X, Wang Y. Immune persistence of a single dose of 23-valent pneumococcal polysaccharide vaccine: A 6-year follow-up. Hum Vaccin Immunother. 2025 Dec;21(1):2517489. doi: 10.1080/21645515.2025.2517489. Epub 2025 Jun 19.

Reference Type DERIVED
PMID: 40537903 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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V114-016

Identifier Type: OTHER

Identifier Source: secondary_id

2017-004024-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-016

Identifier Type: -

Identifier Source: org_study_id