A Study of V132 in Healthy Older Participants (V132-001)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: V132 Formulation 1, V132 Formulation 2, V132 Formulation 3, PREVNAR 20™.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 50 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blind, Comparator-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V132 in Healthy Older Participants
Overview
The goal of this study is to learn about the safety and immune response to the V132 vaccine in healthy older adults.
Interventions
- Biological V132 Formulation 1
Experimental - Biological V132 Formulation 2
Experimental - Biological V132 Formulation 3
Experimental - Biological PREVNAR 20™
Active Comparator - Biological CAPVAXIVE™
Active Comparator
Primary outcome measures
- Percentage of Participants with Immediate Reactions Occurring Within 30 Minutes After Any Vaccination [Time frame: Up to approximately 30 minutes post vaccination]
- Percentage of Participants with a Solicited Injection-site Adverse Event [Time frame: Up to approximately 7 days post vaccination]
- Percentage of Participants with a Solicited Systemic Adverse Event [Time frame: Up to approximately 7 days post vaccination]
- Percentage of Participants With at Least 1 Unsolicited Adverse Event [Time frame: Up to approximately 28 days post vaccination]
- Percentage of Participants with a Serious Adverse Event [Time frame: Up to approximately 12 months post vaccination]
- Percentage of Participants With at Least 1 Medically Attended Adverse Event [Time frame: Up to approximately 12 months post vaccination]
- Percentage of Participants Who Experienced an Adverse Event of Clinical Interest [Time frame: Up to approximately 12 months post vaccination]
Secondary outcome measures (2)
- Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) [Time frame: Up to approximately 28 days post vaccination]
- Geometric Mean Fold Rise from Baseline of Serotype-specific OPA [Time frame: Baseline (pre-vaccination) and 28 days post vaccination]
Eligibility criteria
Inclusion criteria
The key inclusion criteria include but are not limited to the following:
- Is in good health
- Has body mass index (BMI) within 18.0 to 35.0 kg/m\^2 (inclusive)
Exclusion criteria
The key exclusion criteria include but are not limited to the following:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07712575 · V132-001 · V132-001