Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

September 27, 2023 updated by: Merck Sharp & Dohme LLC

A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 812-0025
        • Souseikai PS Clinic ( Site 0201)
      • Kumamoto, Japan, 861-4157
        • Souseikai Nishikumamoto Hospital ( Site 0202)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • is a healthy Japanese male or female ≥20 years of age at time of randomization
  • male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
  • female participants must not be pregnant or breastfeeding, and is either:
  • not a woman of childbearing potential (WOCBP) or
  • a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention

Exclusion Criteria:

  • has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
  • has a known hypersensitivity to any vaccine components
  • has impaired immunological function
  • has a coagulation disorder
  • had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
  • has a known malignancy that is progressing/requiring treatment
  • has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
  • has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
  • is receiving immunosuppressive therapy
  • has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
  • has received any live vaccine from 30 days prior to Day 1
  • has received a blood transfusion or blood products
  • has participated in another clinical trial within 2 months of this study
  • has clinically relevant drug or alcohol abuse
  • has any condition that, in the opinion of the investigator, precludes participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: V116
Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
Biological: V116
Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Other Names:
  • Pneumococcal 21-valent Conjugate Vaccine
  • Polyvalent pneumococcal conjugate vaccine (pPCV)
Active Comparator: PNEUMOVAX™23
Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
Biological: PNEUMOVAX™23
Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Other Names:
  • PPSV23

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time Frame: Up to 5 days postvaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Up to 5 days postvaccination
Percentage of Participants With a Solicited Systemic AE
Time Frame: Up to 5 days postvaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.
Up to 5 days postvaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
Time Frame: Up to 62 days postvaccination
An SAE is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.
Up to 62 days postvaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Time Frame: Day 30 postvaccination
The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.
Day 30 postvaccination
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Time Frame: Day 30 postvaccination
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Day 30 postvaccination
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Time Frame: Day 30 postvaccination
The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Day 30 postvaccination
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Time Frame: Day 30 postvaccination
The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Day 30 postvaccination
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Time Frame: Baseline (Day 1) and Day 30 postvaccination
GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Baseline (Day 1) and Day 30 postvaccination
GMFR From Baseline in Serotype-specific IgG GMCs
Time Frame: Baseline (Day 1) and Day 30 postvaccination
GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Baseline (Day 1) and Day 30 postvaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 6, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pPCV-002 (Other Identifier: Merck)
  • jRCT2071200094 (Registry Identifier: jRCT)
  • V116-002 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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