A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Sponsor:
Merck Sharp & Dohme Corp.
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | December 13, 2018 | ||
| Estimated Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK) |
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| Official Title ICMJE | 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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| Brief Summary | This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™. |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Prevention |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
2400 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | January 8, 2021 | ||
| Estimated Primary Completion Date | January 8, 2021 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator - Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent - 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. Exclusion Criteria: - History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease - Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine - Known or suspected impairment of immunological function - History of congenital or acquired immunodeficiency - Has or his/her mother has a documented human immunodeficiency virus (HIV) infection - Known or history of functional or anatomic asplenia - Failure to thrive based on the clinical judgment of the investigator - Known coagulation disorder contraindicating intramuscular vaccination - 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) - Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders - Received a dose of any pneumococcal vaccine prior to study entry - Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine - 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. - Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study - Has an immediate family member who is investigational site or Sponsor staff directly involved with this study. | ||
| Sex/Gender |
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| Ages | 42 Days and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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