A Study of V118E in Healthy Participants (V118E-003)
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-49
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination
Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
Trial design
Design model
Sequential
Treatments tested in this trial
V118E
Biological/VaccineIM administration
PREVNAR 20™
Biological/VaccineIM administration
Saline
Biological/VaccineIM administration
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: V118EExperimental treatment 1 intervention
Group B: PREVNAR 20™ + SalineActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Solicited Injection-Site Adverse Events (AEs)
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.
Time frame
Up to approximately 7 days after each vaccination2
Number of Participants With Solicited Systemic AEs
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.
Time frame
Up to approximately 7 days after each vaccination3
Number of Participants With Immediate AEs Following 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.
Time frame
Up to approximately 30 minutes after each vaccination4
Number of Participants With Unsolicited AEs
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.
Time frame
Up to approximately 28 days after each vaccinationSecondary outcomes
1
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs)
The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (Pn ECL) assay.
Time frame
Day 28 Postvaccination 12
Change From Baseline in Serotype-specific IgG GMCs
Change from baseline in GMCs for serotype-specific IgG antibodies will be determined using Pn ECL assay.
Time frame
Baseline and Day 28 Postvaccination 1Sponsors and contacts
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Source ClinicalTrials.gov