Pneumococcal InfectionsPhase 3PNEU-PATHNCT03480763

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 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 22 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: V114, Prevnar 13™ and PNEUMOVAX™23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 652 participants
Where: 22 sitesin 4 countries
Study dates: 22 Jun 2018to 23 Dec 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

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 locations and contacts

22 sites in 4 countries.

Country

City, postcode or hospital

22 sites in 4 countries

United States15 sites

East Valley Family Physicians ( Site 0104)
Chandler, Arizona, 85224
Rapid Medical Research, Inc. ( Site 0119)
Cleveland, Ohio, 44122
Clinical Research of South Florida ( Site 0126)
Coral Gables, Florida, 33134
Centennial Medical Group ( Site 0109)
Elkridge, Maryland, 21075
University of Texas Medical Branch at Galveston ( Site 0127)
Galveston, Texas, 77555-1115
Texas Center For Drug Development ( Site 0107)
Houston, Texas, 77081
Health Research of Hampton Roads, Inc. ( Site 0106)
Newport News, Virginia, 23606
Central Phoenix Medical Clinic, LLC ( Site 0125)
Phoenix, Arizona, 85020
J Lewis Research Inc / Foothill Family Clinic ( Site 0123)
Salt Lake City, Utah, 84109
Diagnostics Research Group ( Site 0100)
San Antonio, Texas, 78229
J Lewis Research Inc/Jordan River Family Medicine ( Site 0114)
South Jordan, Utah, 84095
QPS Miami Research Associates ( Site 0116)
South Miami, Florida, 33143
Encompass Clinical Research ( Site 0118)
Spring Valley, California, 91978
Diablo Clinical Research, Inc ( Site 0132)
Walnut Creek, California, 94598
Heartland Research Associates, Llc ( Site 0115)
Wichita, Kansas, 67207

Other trials in United States

Spain3 sites

Instituto de Ciencias Medicas.ICM ( Site 0301)
Alicante, 03004
CAP Centelles ( Site 0303)
Centelles, Barcelona, 08540
Fundacion Oftalmologica del Mediterraneo ( Site 0300)
Valencia, 46015

Other trials in Spain

South Korea2 sites

Seoul National University Hospital ( Site 0400)
Seoul, 03080
Korea University Guro Hospital ( Site 0401)
Seoul, 08308

Other trials in South Korea

Taiwan2 sites

National Cheng Kung University Hospital ( Site 0502)
Dawan, 70403
National Taiwan University Hospital ( Site 0500)
Taipei, 100

Other trials in Taiwan

About this study

Official title: 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)

Conditions: Pneumococcal Infections
Being tested: V114, Prevnar 13™, PNEUMOVAX™23
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V114Biological
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
Prevnar 13™Biological
Also called PCV13
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™23Biological
Also called PPV23
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

Study groups in NCT03480763
Study group	Role	What they receive
V114	Experimental	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) Receives: Biological: V114; Biological: PNEUMOVAX™23
Prevnar 13™	Active comparator	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) Receives: Biological: Prevnar 13™; Biological: PNEUMOVAX™23

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Measured: Up to 5 days after Vaccination 1
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Measured: Up to 5 days after Vaccination 2
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Measured: Up to 14 days after Vaccination 1
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Measured: Up to 14 days after Vaccination 2
Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
Measured: Up to 12 months after Vaccination 1
Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
Measured: Month 12 to Month 13 (Up to 44 days after Vaccination 2)
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Measured: Month 13 (30 days after Vaccination 2)

Secondary outcomes (21)

Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Measured: Month 13 (30 days after Vaccination 2)
GMT of Serotype-specific OPA at Day 30
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Measured: Day 30
GMC of Serotype-specific IgG at Day 30
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Measured: Day 30
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific IgG Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Day 30
GMT of Serotype-specific OPA at Month 12
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Measured: Month 12
GMC of Serotype-specific IgG at Month 12
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Measured: Month 12
GMFR in Serotype-specific OPA Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific IgG Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific OPA Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific IgG Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Measured: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific OPA Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Measured: Month 12 (Baseline) and Month 13
GMFR in Serotype-specific IgG Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Measured: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Measured: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Measured: Month 12 (Baseline) and Month 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 201823 Dec 2019

First posted29 Mar 2018
Study start22 Jun 2018
Primary completion23 Dec 2019
Study completion23 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 652 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03480763
Sponsor's protocol ID: V114-016
Other IDs: V114-016, 2017-004024-30, 2017
Acronym: PNEU-PATH
Status last verified: Oct 2021
First submitted: 22 Mar 2018
Last updated: 2 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

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.
PubMed 34489128
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.
PubMed 40537903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1
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Pneumonia, Bacterial
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT03480763
Acronym / sponsor ID: PNEU-PATH / V114-016
Conditions: Pneumococcal Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 652 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 22 Jun 2018 (actual)
Primary completion: 23 Dec 2019 (actual)
Study completion: 23 Dec 2019 (actual)
First posted: 29 Mar 2018 (actual)
Results: Posted 6 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
V114	Experimental	Biological: V114, Biological: PNEUMOVAX™23Participants 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)
Prevnar 13™	Active comparator	Biological: Prevnar 13™, Biological: PNEUMOVAX™23Participants 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)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V11415-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	Biological	V114
Prevnar 13™Also: PCV1313-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	Biological	Prevnar 13™
PNEUMOVAX™23Also: PPV2323-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	Biological	Prevnar 13™, V114

Primary outcome

Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
Time frame: Up to 5 days after Vaccination 1
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
Time frame: Up to 5 days after Vaccination 2
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
Time frame: Up to 14 days after Vaccination 1
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
Time frame: Up to 14 days after Vaccination 2
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
Time frame: Up to 12 months after Vaccination 1
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
Time frame: Month 12 to Month 13 (Up to 44 days after Vaccination 2)
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Time frame: Month 13 (30 days after Vaccination 2)
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.

21 secondary outcomes

Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Time frame: Month 13 (30 days after Vaccination 2)
GMT of Serotype-specific OPA at Day 30
Time frame: Day 30
GMC of Serotype-specific IgG at Day 30
Time frame: Day 30
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific IgG Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Time frame: Day 1 (Baseline) and Day 30
GMT of Serotype-specific OPA at Month 12
Time frame: Month 12
GMC of Serotype-specific IgG at Month 12
Time frame: Month 12
GMFR in Serotype-specific OPA Day 1 to Month 12
Time frame: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific IgG Day 1 to Month 12
Time frame: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Time frame: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Time frame: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific OPA Day 1 to Month 13
Time frame: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific IgG Day 1 to Month 13
Time frame: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Time frame: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Time frame: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific OPA Month 12 to Month 13
Time frame: Month 12 (Baseline) and Month 13
GMFR in Serotype-specific IgG Month 12 to Month 13
Time frame: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Time frame: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Time frame: Month 12 (Baseline) and Month 13

Results and safety

Results posted to the registry on 6 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V114	327	303
Prevnar 13™	325	306

Primary outcome: Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™

Time frame: Up to 5 days after Vaccination 1. Number. Unit: Percentage of Participants

Measure	V114 n = 327	Prevnar 13™ n = 324
Injection site redness/erythema	9.8	5.6
Injection site tenderness/pain	55.0	41.4
Injection site swelling	16.2	11.4

V114 vs Prevnar 13™: Difference in Percent: 4.2 (95% CI 0.1 to 8.5), p = 0.043, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 13.7 (95% CI 6.0 to 21.2), p <0.001, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 4.8 (95% CI -0.5 to 10.2), p = 0.077, Miettinen & Nurminen

Population analysed: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)

Primary outcome: Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23

Time frame: Up to 5 days after Vaccination 2. Number. Unit: Percentage of Participants

Measure	V114 n = 298	Prevnar 13™ n = 302
Injection site redness/erythema	17.4	16.9
Injection site tenderness/pain	62.1	58.6
Injection site swelling	28.2	26.2

V114 vs Prevnar 13™: Difference in Percent: 0.6 (95% CI -5.5 to 6.6), p = 0.855, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 3.5 (95% CI -4.4 to 11.3), p = 0.385, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 2.0 (95% CI -5.1 to 9.2), p = 0.577, Miettinen & Nurminen

Population analysed: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.

Primary outcome: Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™

Time frame: Up to 14 days after Vaccination 1. Number. Unit: Percentage of Participants

Measure	V114 n = 327	Prevnar 13™ n = 324
Joint pain/arthralgia	6.4	5.2
Tiredness/fatigue	23.5	13.9
Headache	14.1	12.7
Muscle pain/myalgia	17.7	11.1

V114 vs Prevnar 13™: Difference in Percent: 1.2 (95% CI -2.5 to 4.9), p = 0.523, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 9.7 (95% CI 3.7 to 15.6), p = 0.002, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 1.4 (95% CI -3.9 to 6.7), p = 0.597, Miettinen & Nurminen

Primary outcome: Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23

Time frame: Up to 14 days after Vaccination 2. Number. Unit: Percentage of Participants

Measure	V114 n = 298	Prevnar 13™ n = 302
Joint pain/arthralgia	8.4	8.3
Tiredness/fatigue	25.8	21.9
Headache	12.1	12.6
Muscle pain/myalgia	21.5	16.6

V114 vs Prevnar 13™: Difference in Percent: 0.1 (95% CI -4.4 to 4.7), p = 0.961, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: 4.0 (95% CI -2.8 to 10.8), p = 0.252, Miettinen & Nurminen
V114 vs Prevnar 13™: Difference in Percent: -0.5 (95% CI -5.8 to 4.8), p = 0.852, Miettinen & Nurminen

Population analysed: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114	17 of 327 (5.2%)	221 of 327 (67.6%)	0 of 327
Prevnar 13™	19 of 324 (5.9%)	181 of 324 (55.9%)	0 of 324
V114 (Post-PNEUMOVAX™23)	1 of 298 (0.3%)	217 of 298 (72.8%)	0 of 298
Prevnar 13™ (Post-PNEUMOVAX™23)	2 of 302 (0.7%)	210 of 302 (69.5%)	0 of 302

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34489128Song 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.
Derived from this study: PubMed 40537903Huang 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.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

22 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114, Prevnar 13™ and PNEUMOVAX™23 in people with Pneumococcal Infections, run by Merck Sharp & Dohme LLC at 22 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Spain, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ (time frame: Up to 5 days after Vaccination 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480763, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.