Pneumococcal InfectionPhase 1NCT04665050

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

A Phase 1 study testing V116 and PNEUMOVAX™23 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 2 sites in Japan.

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

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. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infection
What is being tested?: V116 and PNEUMOVAX™23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 2 sitesJapan
Study dates: 4 Feb 2021to 6 Apr 2021
Phase: Phase 1
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 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

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

Other trials in Japan

About this study

Official title: 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.

Conditions: Pneumococcal Infection
Being tested: V116, 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.

V116Biological
Also called Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine
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
PNEUMOVAX™23Biological
Also called PPSV23
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

Study groups in NCT04665050
Study group	Role	What they receive
V116	Experimental	Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1. Receives: Biological: V116
PNEUMOVAX™23	Active comparator	Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1. Receives: Biological: PNEUMOVAX™23

What is being measured

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

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
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.
Measured: Up to 5 days postvaccination
Percentage of Participants With a Solicited Systemic AE
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.
Measured: Up to 5 days postvaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
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.
Measured: Up to 62 days postvaccination

Secondary outcomes (6)

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
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.
Measured: Day 30 postvaccination
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
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.
Measured: Day 30 postvaccination
Serotype-specific OPA GMTs for the Unique Serotypes in V116
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.
Measured: Day 30 postvaccination
Serotype-specific IgG GMCs for the Unique Serotypes in V116
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.
Measured: Day 30 postvaccination
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
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.
Measured: Baseline (Day 1) and Day 30 postvaccination
GMFR From Baseline in Serotype-specific IgG GMCs
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.
Measured: Baseline (Day 1) and Day 30 postvaccination

Timeline

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

4 Feb 20216 Apr 2021

First posted11 Dec 2020
Study start4 Feb 2021
Primary completion6 Apr 2021
Study completion6 Apr 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04665050
Sponsor's protocol ID: pPCV-002
Other IDs: pPCV-002, jRCT2071200094, V116-002
Status last verified: Sep 2023
First submitted: 8 Dec 2020
Last updated: 4 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.
PubMed 37389808

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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All Pneumococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT04665050
Acronym / sponsor ID: pPCV-002
Conditions: Pneumococcal Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 4 Feb 2021 (actual)
Primary completion: 6 Apr 2021 (actual)
Study completion: 6 Apr 2021 (actual)
First posted: 11 Dec 2020 (actual)
Results: Posted 7 Jul 2023

Clinical summary

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

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 design

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

Arm	Type	Receives
V116	Experimental	Biological: V116Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
PNEUMOVAX™23	Active comparator	Biological: PNEUMOVAX™23Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (15 listed)

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

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
V116Also: Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate VaccinePneumococcal 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	Biological	V116
PNEUMOVAX™23Also: PPSV23Pneumococcal 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	Biological	PNEUMOVAX™23

Primary outcome

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.
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.
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.

6 secondary outcomes

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Time frame: 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
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Time frame: Day 30 postvaccination
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Time frame: 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
GMFR From Baseline in Serotype-specific IgG GMCs
Time frame: Baseline (Day 1) and Day 30 postvaccination

Results and safety

Results posted to the registry on 7 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V116	51	51
PNEUMOVAX™23	51	51

Primary outcome: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

Time frame: Up to 5 days postvaccination. Number. Unit: Percentage of Participants

Measure	V116 n = 51	PNEUMOVAX™23 n = 51
Injection site erythema	9.8	9.8
Injection site pain	54.9	66.7
Injection site swelling	13.7	13.7

V116 vs PNEUMOVAX™23: Difference in percentage: 0.0 (95% CI -12.7 to 12.7)
V116 vs PNEUMOVAX™23: Difference in percentage: -11.8 (95% CI -30.0 to 7.3)
V116 vs PNEUMOVAX™23: Difference in percentage: 0.0 (95% CI -14.1 to 14.1)

Population analysed: All randomized participants who received study vaccination

Primary outcome: Percentage of Participants With a Solicited Systemic AE

Time frame: Up to 5 days postvaccination. Number. Unit: Percentage of participants

Measure	V116 n = 51	PNEUMOVAX™23 n = 51
Fatigue	13.7	9.8
Arthralgia	3.9	3.9
Myalgia	17.6	19.6
Headache	9.8	9.8

V116 vs PNEUMOVAX™23: Difference in percentage: 3.9 (95% CI -9.4 to 17.5)
V116 vs PNEUMOVAX™23: Difference in percentage: 0.0 (95% CI -9.9 to 9.9)
V116 vs PNEUMOVAX™23: Difference in percentage: -2.0 (95% CI -17.5 to 13.6)

Population analysed: All randomized participants who received study vaccination

Primary outcome: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

Time frame: Up to 62 days postvaccination. Number. Unit: Percentage of participants

Measure	V116 n = 51	PNEUMOVAX™23 n = 51
Value	0.0	0.0

V116 vs PNEUMOVAX™23: Difference in percentage: 0.0 (95% CI -7.1 to 7.1)

Population analysed: All randomized participants who received study vaccination

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 62 days postvaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V116	0 of 51 (0%)	30 of 51 (58.8%)	0 of 51
PNEUMOVAX™23	0 of 51 (0%)	35 of 51 (68.6%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37389808Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.
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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V116 and PNEUMOVAX™23 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 2 sites in Japan.

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 5 inclusion and 15 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 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 7 Jul 2023). 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 a Solicited Injection-site Adverse Event (AE) (time frame: Up to 5 days postvaccination). The study lists 3 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 NCT04665050, which also lists 1 linked publication.

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 4 Oct 2023.