A Study of V132 in Healthy Older Participants (V132-001)
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorMerck Sharp & Dohme LLC
About this trial
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health
Has body mass index (BMI) within 18.0 to 35.0 kg/m² (inclusive)
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 received a pneumococcal polysaccharide vaccine in the previous 10 years, has received any pneumococcal conjugate vaccine at any time prior to this study
Trial design
Design model
Sequential
Treatments tested in this trial
V132 Formulation 1
Biological/VaccineExperimental
V132 Formulation 2
Biological/VaccineExperimental
V132 Formulation 3
Biological/VaccineExperimental
PREVNAR 20™
Biological/VaccineActive Comparator
CAPVAXIVE™
Biological/VaccineActive Comparator
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Part 1: Dose EscalationExperimental treatment 5 interventions
Group B: Part 2: Dose ExpansionExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with immediate reactions occurring within 30 minutes after any vaccination will be reported.
Time frame
Up to approximately 30 minutes post vaccination2
Percentage of Participants with a Solicited Injection-site Adverse Event
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The solicited injection-site AEs assessed are redness/erythema, swelling, and tenderness/pain. The percentage of participants with a solicited injection-site adverse event will be reported.
Time frame
Up to approximately 7 days post vaccination3
Percentage of Participants with a Solicited Systemic 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 solicited systemic AEs assessed are muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with a solicited systemic adverse event will be reported.
Time frame
Up to approximately 7 days post vaccination4
Percentage of Participants With at Least 1 Unsolicited Adverse Event
An unsolicited AE is an AE that was not solicited using a vaccination report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs. The percentage of participants with at least 1 unsolicited adverse event will be reported.
Time frame
Up to approximately 28 days post vaccinationSecondary outcomes
1
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA)
Opsonophagocytic activity (OPA) for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA). Geometric Mean Titer (GMT) of serotype-specific OPA will be reported.
Time frame
Up to approximately 28 days post vaccination2
Geometric Mean Fold Rise from Baseline of Serotype-specific OPA
The Geometric Mean Fold Rise (GMFR) from baseline in serotype-specific OPA GMTs for serotypes in V132 formulations will be determined using a multiplexed opsonophagocytic assay (MOPA). GMFR is defined as the geometric mean of the ratio of concentration at Day 28 post vaccination divided by concentration at baseline.
Time frame
Baseline (pre-vaccination) and 28 days post vaccinationSponsors and contacts
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Source ClinicalTrials.gov