Clinical Trials List
Protocol NumberV114-031
NCT Number(ClinicalTrials.gov Identfier)NCT03692871
2018-12-01 - 2022-12-31
Phase III
Terminated4
ICD-10B95.3
Streptococcus pneumoniae as the cause of diseases classified elsewhere
ICD-9041.2
Pneumococcus infections of unspecified site
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU -LINK)
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 丁佩如 Division of Pediatrics
- 許雅淇 Division of Pediatrics
- FANG-LIANG HUANG Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Linkou Chang Gung Medical Foundation
Taiwan National PI
邱政洵
Co-Principal Investigator
- 朱世明 Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- 賴美吟 Division of Pediatrics
- 林瑞瑩 Division of Pediatrics
- 李建忠 Division of Pediatrics
- 吳怡萱 Division of Pediatrics
- Jen Fu Hsu Division of Pediatrics
- 許凱翔 Division of Pediatrics
- 郭貞孍 Division of Pediatrics
- 江明洲 Division of Pediatrics
- 楊長佑 Division of Pediatrics
The Actual Total Number of Participants Enrolled
35 Terminated
Audit
None
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- 邢子芸 Division of Pediatrics
- 蔡幸真 Division of Pediatrics
- 陳立倫 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
- 林筱琪 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 戴君芙 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Pneumococcal Infections
Objectives
Primary
• Objective: To evaluate the safety and
tolerability of V114 with respect to the
proportion of participants with adverse
events (AEs).
Secondary
• Objective (Premature Infant
Immunogenicity Substudy only): To
evaluate the anti-pneumococcal
polysaccharide (PnPs) serotype-specific
Immunoglobulin G (IgG) Geometric
Mean Concentrations (GMCs) at 30 days
following Dose 3, prior to Dose 4 and at
30 days following Dose 4 for each
vaccination group.
• Objective (Premature Infant
Immunogenicity Substudy only): To
evaluate the anti-PnPs serotype-specific
IgG response rates (proportion of
participants meeting serotype-specific
IgG threshold value of ≥0.35 μg/mL) at
30 days following Dose 3 for each
vaccination group.
Test Drug
15-Valent Pneumococcal Conjugate Vaccine (V114)
Active Ingredient
15-Valent Pneumococcal Conjugate Vaccine
Dosage Form
Dosage
0.5
Endpoints
Primary Outcome Measures :
Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
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. Solicited injection-site AEs will be redness/erythema, swelling, pain/tenderness, and hard lump/induration.
Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
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. Solicited systemic AEs will be irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria.
Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months after Dose 4 (Month 19) ]
A serious adverse event (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. Relatedness of an SAE to the study vaccine will be determined by the investigator.
Secondary Outcome Measures :
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) at 30 days after Dose 3 [ Time Frame: 30 days after Dose 3 (Month 5) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a pneumococcal electrochemiluminescence (PnECL) assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Geometric Mean Concentration of Serotype-specific IgG before Dose 4 [ Time Frame: Before dose 4 (Month 10-13) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Geometric Mean Concentration of Serotype-specific IgG at 30 Days after Dose 4 [ Time Frame: 30 days after Dose 4 (Month 11-14) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Percentage of Participants Meeting the Serotype-specific IgG Threshold of ≥0.35 µg/mL [ Time Frame: 30 days after Dose 3 (Month 5) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
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. Solicited injection-site AEs will be redness/erythema, swelling, pain/tenderness, and hard lump/induration.
Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after each study vaccination ]
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. Solicited systemic AEs will be irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria.
Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months after Dose 4 (Month 19) ]
A serious adverse event (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. Relatedness of an SAE to the study vaccine will be determined by the investigator.
Secondary Outcome Measures :
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) at 30 days after Dose 3 [ Time Frame: 30 days after Dose 3 (Month 5) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a pneumococcal electrochemiluminescence (PnECL) assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Geometric Mean Concentration of Serotype-specific IgG before Dose 4 [ Time Frame: Before dose 4 (Month 10-13) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Geometric Mean Concentration of Serotype-specific IgG at 30 Days after Dose 4 [ Time Frame: 30 days after Dose 4 (Month 11-14) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Percentage of Participants Meeting the Serotype-specific IgG Threshold of ≥0.35 µg/mL [ Time Frame: 30 days after Dose 3 (Month 5) ]
Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using a PnECL assay. This Outcome Measure is part of the Premature Infant Substudy and will include premature infant participants only.
Inclution Criteria
Inclusion Criteria
To be eligible for inclusion in this study, the participant must:
1. Be healthy (based on a review of medical history and physical examination) based on the
clinical judgement of the investigator.
Demographics
2. Be male or female approximately 2 months of age, from 42 days to 90 days inclusive, at
the time of obtaining the informed consent.
Informed Consent
3. Have a legally acceptable representative who understands the study procedures, alternate
treatments available, and risks involved with the study and voluntarily agrees to
participate by giving written informed consent. The legally acceptable representative may
also provide consent for future biomedical research. However, the participant may
participate in the main study without participating in future biomedical research.
To be eligible for inclusion in this study, the participant must:
1. Be healthy (based on a review of medical history and physical examination) based on the
clinical judgement of the investigator.
Demographics
2. Be male or female approximately 2 months of age, from 42 days to 90 days inclusive, at
the time of obtaining the informed consent.
Informed Consent
3. Have a legally acceptable representative who understands the study procedures, alternate
treatments available, and risks involved with the study and voluntarily agrees to
participate by giving written informed consent. The legally acceptable representative may
also provide consent for future biomedical research. However, the participant may
participate in the main study without participating in future biomedical research.
Exclusion Criteria
Exclusion Criteria
The participant must be excluded from the study if the participant:
Medical Conditions
1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other
sterile site) or known history of other culture positive pneumococcal disease.
2. Has a known hypersensitivity to any component of the PCV or any diphtheria toxoidcontaining vaccine.
3. *Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary
temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of study
vaccine.
4. Has a known or suspected impairment of immunological function.
5. Has a history of congenital or acquired immunodeficiency.
6. Has or his/her mother has a documented human immunodeficiency virus (HIV) infection.
7. Has known or history of functional or anatomic asplenia.
8. Has failure to thrive based on the clinical judgement of the investigator.
9. Has a known coagulation disorder contraindicating intramuscular vaccination.
10. Has a history of autoimmune disease (including but not limited to systemic lupus
erythematosus, antiphospholipid syndrome, Behcet’s disease, autoimmune thyroid
disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or
other autoimmune disorders).
11. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis,
acute disseminating encephalomyelitis, pervasive development disorder, and related
disorders.
Prior/Concomitant Therapy
12. Has received a dose of any pneumococcal vaccine prior to study entry.
13. *Meets one or more of the following systemic corticosteroid exclusion criteria:
a. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of
prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days
and has not completed this course of treatment at least 30 days prior to the first dose
of study vaccine at randomization.
b. Has received systemic corticosteroids within 14 days prior to the first dose of study
vaccine at randomization.
c. Is expected to require systemic corticosteroids within 30 days after each vaccination
during conduct of the study.
Note: Topical, ophthalmic and inhaled steroids are permitted.
14. *Has received other licensed non-live vaccines within the 14 days before receipt of first
dose of study vaccine.
15. *Has received a licensed live virus vaccine within the 30 days before receipt of first dose
of study vaccine.
16. Has received a blood transfusion or blood products, including immunoglobulins, before
receipt of first dose of study vaccine.
Prior/Concurrent Clinical Study Experience
17. Has participated in another clinical study of an investigational product before the
beginning or anytime during the duration of the current clinical study. Participants
enrolled in observational studies may be included; these will be reviewed on a case-bycase basis for approval by the Sponsor.
Other Exclusions
18. Has any other reason that, in the opinion of the investigator, may interfere with the
evaluation required by the study. Reasons may include, but are not limited to, being
unable to keep appointments or planning to relocate during the study.
19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or
child) who is investigational site or Sponsor staff directly involved with this study.
The participant must be excluded from the study if the participant:
Medical Conditions
1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or other
sterile site) or known history of other culture positive pneumococcal disease.
2. Has a known hypersensitivity to any component of the PCV or any diphtheria toxoidcontaining vaccine.
3. *Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary
temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of study
vaccine.
4. Has a known or suspected impairment of immunological function.
5. Has a history of congenital or acquired immunodeficiency.
6. Has or his/her mother has a documented human immunodeficiency virus (HIV) infection.
7. Has known or history of functional or anatomic asplenia.
8. Has failure to thrive based on the clinical judgement of the investigator.
9. Has a known coagulation disorder contraindicating intramuscular vaccination.
10. Has a history of autoimmune disease (including but not limited to systemic lupus
erythematosus, antiphospholipid syndrome, Behcet’s disease, autoimmune thyroid
disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or
other autoimmune disorders).
11. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis,
acute disseminating encephalomyelitis, pervasive development disorder, and related
disorders.
Prior/Concomitant Therapy
12. Has received a dose of any pneumococcal vaccine prior to study entry.
13. *Meets one or more of the following systemic corticosteroid exclusion criteria:
a. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of
prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days
and has not completed this course of treatment at least 30 days prior to the first dose
of study vaccine at randomization.
b. Has received systemic corticosteroids within 14 days prior to the first dose of study
vaccine at randomization.
c. Is expected to require systemic corticosteroids within 30 days after each vaccination
during conduct of the study.
Note: Topical, ophthalmic and inhaled steroids are permitted.
14. *Has received other licensed non-live vaccines within the 14 days before receipt of first
dose of study vaccine.
15. *Has received a licensed live virus vaccine within the 30 days before receipt of first dose
of study vaccine.
16. Has received a blood transfusion or blood products, including immunoglobulins, before
receipt of first dose of study vaccine.
Prior/Concurrent Clinical Study Experience
17. Has participated in another clinical study of an investigational product before the
beginning or anytime during the duration of the current clinical study. Participants
enrolled in observational studies may be included; these will be reviewed on a case-bycase basis for approval by the Sponsor.
Other Exclusions
18. Has any other reason that, in the opinion of the investigator, may interfere with the
evaluation required by the study. Reasons may include, but are not limited to, being
unable to keep appointments or planning to relocate during the study.
19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or
child) who is investigational site or Sponsor staff directly involved with this study.
The Estimated Number of Participants
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Taiwan
135 participants
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Global
2400 participants
