Pneumococcal DiseasePhase 3PNEU-PED-KORNCT04633226

Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

A Phase 3 study testing V114 in people with Pneumococcal Disease, run by Merck Sharp & Dohme LLC at 19 sites in South Korea.

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 primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea. Read more about this study

Who is it for?: Ages 42 to 90 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: V114
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 19 sitesSouth Korea
Study dates: 10 Feb 2021to 4 Nov 2022
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 42 to 90 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent

Who cannot join

has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
has had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) within 72 hours prior to receipt of study vaccine
has known or suspected impairment of immunological function
has or his/her mother has human immunodeficiency virus (HIV) infection
has or his/her mother has hepatitis B surface antigen-positive test

Show all 13Show fewer

has known or history of functional or anatomic asplenia
has a history of autoimmune disease
has a history or suspected history of neurological disorder
has received a pneumococcal vaccine prior to study entry
has received, or is anticipated to need, corticosteroid therapy
has received a blood transfusion of immunoglobulin products
has participated in another clinical study of an investigational product

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

South Korea19 sites

Korea University Ansan Hospital ( Site 0006)
Ansan-si, Kyonggi-do, 15355
Hallym University Sacred Heart Hospital ( Site 0011)
Anyang-si, Kyonggi-do, 14068
Changwon Fatima Hospital ( Site 0015)
Changwon, Kyongsangnam-do, 51394
Kyungpook National University Hospital ( Site 0014)
Daegu, Taegu-Kwangyokshi, 41944
Hallym University Dongtan Sacred Heart Hospital ( Site 0013)
Hwaseong-si, Kyonggi-do, 18450
The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012)
Incheon, 21431
Gachon University Gil Medical Center ( Site 0019)
Incheon, 21565
Inha University Hospital ( Site 0001)
Incheon, 22332
Jeonbuk National University Hospital ( Site 0008)
Jeonju, Jeonrabugdo, 54907
CHA Bundang Medical Center CHA University ( Site 0020)
Seongnam-si, Kyonggi-do, 13496
Korea Cancer Center Hospital ( Site 0017)
Seoul, 01812
Nowon Eulji Medical Center, Eulji University ( Site 0005)
Seoul, 01830
Severance Hospital Yonsei University Health System ( Site 0002)
Seoul, 03722
Samsung Medical Center ( Site 0007)
Seoul, 06351
The Catholic University of Korea ( Site 0003)
Seoul, 06591
Chung-Ang University Hospital ( Site 0016)
Seoul, 06973
Ewha Womans University Seoul Hospital ( Site 0010)
Seoul, 07804
Korea University Guro Hospital ( Site 0021)
Seoul, 08308
Pusan National University Yangsan Hospital ( Site 0009)
Yangsan, Kyongsangnam-do, 50612

Other trials in South Korea

About this study

Official title: A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

Conditions: Pneumococcal Disease
Being tested: V114
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
Also called VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.

Study groups in NCT04633226
Study group	Role	What they receive
V114	Experimental	Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. Receives: Biological: V114

What is being measured

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

Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
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 any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.
Measured: Up to 7 days after any vaccination, up to a total of ~ 13 months
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
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 any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of decreased appetite, irritability, somnolence, and urticaria.
Measured: Up to 7 days after any vaccination, up to a total of ~ 13 months
Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events
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. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Measured: Up to approximately 14.5 months
Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event
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. The percentage of participants who discontinued study treatment due to an AE is reported.
Measured: Up to approximately 13 months
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
The percentage of participants with immunoglobulin G (IgG) threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies.
Measured: 30 days after vaccination 3 (Up to a total of ~5 months)
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
The anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG geometric mean concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay was used to quantify IgG serotype-specific antibodies.
Measured: 30 days after vaccination 3 (Up to a total of ~5 months)

Secondary outcomes (1)

Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
The anti-PnPs serotype-specific IgG GMCs at 30 days postdose 4 for each serotype-specific were reported. The multiplex, ECL-based PnECL v2.0 assay was used.
Measured: 30 days after vaccination 4 (Up to a total of ~14 months)

Timeline

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

10 Feb 20214 Nov 2022

First posted18 Nov 2020
Study start10 Feb 2021
Primary completion4 Nov 2022
Study completion4 Nov 2022

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 DiseaseStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04633226
Sponsor's protocol ID: V114-036
Other IDs: V114-036, 2020-003181-39
Acronym: PNEU-PED-KOR
Status last verified: Sep 2024
First submitted: 11 Nov 2020
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Maestri A, Park SE, Fernandes F, Li ZL, Kim YJ, Kim YK, Lee J, Park JY, Kim DH, Yang G, Lim H, Kim JO, Lupinacci R, Sterling TM, Wilck M, Esteves-Jaramillo A, Banniettis N. A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). Hum Vaccin Immunother. 2024 Dec 31;20(1):2321035. doi: 10.1080/21645515.2024.2321035. Epub 2024 Mar 18.
PubMed 38497448

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.
ClinicalTrials.gov ID: NCT04633226
Acronym / sponsor ID: PNEU-PED-KOR / V114-036
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Feb 2021 (actual)
Primary completion: 4 Nov 2022 (actual)
Study completion: 4 Nov 2022 (actual)
First posted: 18 Nov 2020 (actual)
Results: Posted 15 Apr 2024

Clinical summary

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

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
V114	Experimental	Biological: V114Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age.

Who may qualify

Ages: 42 to 90 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent

Key exclusion criteria (13 listed)

has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
has had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) within 72 hours prior to receipt of study vaccine
has known or suspected impairment of immunological function
has or his/her mother has human immunodeficiency virus (HIV) infection

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
V114Also: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection.	Biological	V114

Primary outcome

Percentage of Participants With ≥1 Solicited Injection-site Adverse Events
Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months
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 any of the doses of V114, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs consist of erythema, induration, pain, and swelling.
Percentage of Participants With ≥1 Solicited Systemic Adverse Events
Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months
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 any of the doses of V114, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs consist of decreased appetite, irritability, somnolence, and urticaria.
Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events
Time frame: Up to approximately 14.5 months
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. The percentage of participants with a vaccine-related SAE following any dose of V114 was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study.
Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event
Time frame: Up to approximately 13 months
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. The percentage of participants who discontinued study treatment due to an AE is reported.
Percentage of Participants With Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G ≥0.35 µg/mL
Time frame: 30 days after vaccination 3 (Up to a total of ~5 months)
The percentage of participants with immunoglobulin G (IgG) threshold values of ≥0.35 µg/mL for the 15 serotypes contained in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 30 days postdose 3 is reported. The multiplex, pneumococcal electrochemiluminescence (PnECL) v2.0 assay was used to quantify IgG serotype-specific antibodies.
Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 3
Time frame: 30 days after vaccination 3 (Up to a total of ~5 months)
The anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG geometric mean concentrations (GMCs) at 30 days postdose 3 for each serotype-specific were reported. The multiplex, electrochemiluminescence (ECL)-based PnECL v2.0 assay was used to quantify IgG serotype-specific antibodies.

1 secondary outcome

Geometric Mean Concentrations of Anti-Pneumococcal Polysaccharides Serotype-specific Immunoglobulin G at 30 Days Postdose 4
Time frame: 30 days after vaccination 4 (Up to a total of ~14 months)

Results and safety

Results posted to the registry on 15 Apr 2024, 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	58	53

Primary outcome: Percentage of Participants With ≥1 Solicited Injection-site Adverse Events

Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months. Number. Unit: Percentage of Participants

Measure	V114 n = 57
Injection site erythema	54.4
Injection site induration	57.9
Injection site pain	50.9
Injection site swelling	59.6

Population analysed: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Primary outcome: Percentage of Participants With ≥1 Solicited Systemic Adverse Events

Time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months. Number. Unit: Percentage of Participants

Measure	V114 n = 57
Decreased appetite	71.9
Irritability	89.5
Somnolence	82.5
Urticaria	8.8

Population analysed: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Primary outcome: Percentage of Participants With ≥1 Vaccine-related Serious Adverse Events

Time frame: Up to approximately 14.5 months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 n = 57
Value	0.0 (0.0)

Population analysed: All randomized participants who received at least 1 dose of study vaccination were analyzed.

Primary outcome: Percentage of Participants Discontinuing Study Therapy Due to an Adverse Event

Time frame: Up to approximately 13 months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	V114 n = 57
Value	0.0 (0.0)

Population analysed: The analysis population consisted of all participants who received at least 1 dose of study vaccination.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to ~14.5 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V114	4 of 57 (7%)	56 of 57 (98.2%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 38497448Maestri A, Park SE, Fernandes F, Li ZL, Kim YJ, Kim YK, Lee J, Park JY, Kim DH, Yang G, Lim H, Kim JO, Lupinacci R, Sterling TM, Wilck M, Esteves-Jaramillo A, Banniettis N. A phase 3, single-arm, open-label study to evaluate the safety, tolerability, and immunogenicity of a 15-valent pneumococcal conjugate vaccine, V114, in a 3+1 regimen in healthy infants in South Korea (PNEU-PED-KOR). Hum Vaccin Immunother. 2024 Dec 31;20(1):2321035. doi: 10.1080/21645515.2024.2321035. Epub 2024 Mar 18.
Merck Clinical Trials InformationLink provided by the sponsor.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V114 in people with Pneumococcal Disease, run by Merck Sharp & Dohme LLC at 19 sites in South Korea.

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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in South Korea. 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 15 Apr 2024). 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 ≥1 Solicited Injection-site Adverse Events (time frame: Up to 7 days after any vaccination, up to a total of ~ 13 months). The study lists 6 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 NCT04633226, 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 24 Sep 2024.