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| ID | Type | Description | Link |
|---|---|---|---|
| V114-036 | Other Identifier | MSD | |
| 2020-003181-39 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 | Experimental | Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 | Biological | 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 13â„¢ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after vaccination 4 (Up to a total of ~14 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk National University Hospital ( Site 0008) | Jeonju | Jeonrabugdo | 54907 | South Korea | ||
| Korea University Ansan Hospital ( Site 0006) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38497448 | Result | 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. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2022 |
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|
| 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. | 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. | 30 days after vaccination 3 (Up to a total of ~5 months) |
| Ansan-si |
| Kyonggi-do |
| 15355 |
| South Korea |
| Hallym University Sacred Heart Hospital ( Site 0011) | Anyang-si | Kyonggi-do | 14068 | South Korea |
| Hallym University Dongtan Sacred Heart Hospital ( Site 0013) | Hwaseong-si | Kyonggi-do | 18450 | South Korea |
| CHA Bundang Medical Center CHA University ( Site 0020) | Seongnam-si | Kyonggi-do | 13496 | South Korea |
| Changwon Fatima Hospital ( Site 0015) | Changwon | Kyongsangnam-do | 51394 | South Korea |
| Pusan National University Yangsan Hospital ( Site 0009) | Yangsan | Kyongsangnam-do | 50612 | South Korea |
| Kyungpook National University Hospital ( Site 0014) | Daegu | Taegu-Kwangyokshi | 41944 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 0012) | Incheon | 21431 | South Korea |
| Gachon University Gil Medical Center ( Site 0019) | Incheon | 21565 | South Korea |
| Inha University Hospital ( Site 0001) | Incheon | 22332 | South Korea |
| Korea Cancer Center Hospital ( Site 0017) | Seoul | 01812 | South Korea |
| Nowon Eulji Medical Center, Eulji University ( Site 0005) | Seoul | 01830 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 0002) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 0007) | Seoul | 06351 | South Korea |
| The Catholic University of Korea ( Site 0003) | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital ( Site 0016) | Seoul | 06973 | South Korea |
| Ewha Womans University Seoul Hospital ( Site 0010) | Seoul | 07804 | South Korea |
| Korea University Guro Hospital ( Site 0021) | Seoul | 08308 | South Korea |
| Plain Language Summary | View source |
| Vaccination 1 (~2 Months of Age) |
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| Vaccination 2 (~4 Months of Age) |
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| Vaccination 3 (~6 Months of Age) |
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| Vaccination 4 (~12 to 15 Months of Age) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 | Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | weeks |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Up to 7 days after any vaccination, up to a total of ~ 13 months |
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| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Up to 7 days after any vaccination, up to a total of ~ 13 months |
|
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| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 14.5 months |
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| Primary | 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. | The analysis population consisted of all participants who received at least 1 dose of study vaccination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 13 months |
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| Primary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include randomized but not vaccinated, prior pneumococcal vaccine, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, or missing serology results. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 30 days after vaccination 3 (Up to a total of ~5 months) |
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| Primary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include randomized but not vaccinated, prior pneumococcal vaccine, vaccination out of window, blood draw out of window, prohibited concomitant medication or vaccine, or missing serology results. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 days after vaccination 3 (Up to a total of ~5 months) |
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| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. Deviations include vaccination out of window, blood draw out of window, or prohibited concomitant medication or vaccine. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 days after vaccination 4 (Up to a total of ~14 months) |
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Up to ~14.5 months
All-Cause Mortality was reported for all allocated participants. The analysis population for AEs included all allocated participants who received at least 1 dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V114 | Participants received 4 total doses of V114, administered at approximately 2, 4, 6, and 12 to 15 months of age. | 0 | 58 | 4 | 57 | 56 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Asymptomatic COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Gastroenteritis norovirus | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Urinary tract infection bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Injection site urticaria | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Oct 2, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Newborns (0-27 days) |
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| Infants and toddlers (28 days-23 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Adults (18-64 years) |
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| From 65-84 years |
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| 85 years and over |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Injection site swelling |
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