Healthy
Conditions
Brief summary
Researchers are looking for new vaccines to prevent illnesses caused by a type of bacteria called Streptococcus pneumoniae. There are many different types of Streptococcus pneumoniae bacteria, called serotypes. Vaccines contain small parts of certain serotypes. These parts will not cause an infection but help the body create antibodies (proteins) to fight the bacteria. PREVNAR 20™ is a vaccine given to help to prevent disease from Streptococcus pneumoniae bacteria. Researchers designed a new vaccine, V118E, to help prevent disease from Streptococcus pneumoniae bacteria. The goal of this study is to learn how safe V118 formulation E is in Healthy Adults and how well people tolerate it.
Interventions
BIOLOGICALV118E
IM administration
BIOLOGICALPREVNAR 20™
IM administration
BIOLOGICALSaline
IM administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: \- Is in good health before randomization
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Injection-Site Adverse Events (AEs) | Up to approximately 7 days after each vaccination | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their vaccine report card (VRC). Solicited injection-site AEs include redness, swelling, and pain or tenderness. The number of participants with a solicited injection-site AE will be reported. |
| Number of Participants With Solicited Systemic AEs | Up to approximately 7 days after each vaccination | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. A solicited AE is a predefined event that participants are specifically asked about and record on their VRC. Solicited systemic AEs include fever, muscle aches all over body, joint pain, headache, and tiredness. The number of participants with a solicited systemic AE will be reported. |
| Number of Participants With Immediate AEs Following Vaccination | Up to approximately 30 minutes after each vaccination | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. The number of participants with immediate AEs following vaccination will be reported. |
| Number of Participants With Unsolicited AEs | Up to approximately 28 days after each vaccination | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, which occurs during the course of the study. An unsolicited AE is an event that is not solicited using a VRC and that is communicated by a participant. The number of participants who experience an unsolicited AE will be reported. |
| Number of Participants With a Serious Adverse Event (SAE) | Up to approximately 12 months after final vaccination | An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported. |
| Number of Participants With a Medically Attended Adverse Event (MAAE) | Up to approximately 12 months after final vaccination | A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience a MAAE will be reported. |
| Number of Participants With an Adverse Events of Special Interest (AESI) | Up to approximately 12 months after final vaccination | AESIs are selected serious and nonserious AEs which include but are not limited to: 1) Potential drug-induced liver injury (DILI) events defined as an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is ≥3\* the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is ≥2\* the ULN and, at the same time, an alkaline phosphatase laboratory value that is \<2\* the ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 2) an overdose of V118E. 3) Potential immune-mediated disease (pIMDs) defined as a subset of AEs that an established autoimmune disease(s) AND inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an AESI will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) | Day 28 Postvaccination 1 | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay. |
| Change From Baseline in Serotype-specific IgG GMCs | Baseline and Day 28 Postvaccination 1 | Change from baseline in GMCs for serotype-specific IgG antibodies will be determined using Pn ECL assay. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed