Status and phase
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About
The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Previous pneumococcal disease (either confirmed or self-reported).
Previous receipt of a licensed or investigational pneumococcal vaccine.
Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1.
Physical examination indicating any clinically significant medical condition.
Body Temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C.
History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
Any other chronic or clinically significant medical condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
Received systemic corticosteroids (except for inhaled, topical, intra-articular) for
≥14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
Receiving immunosuppressive therapy.
History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Primary purpose
Allocation
Interventional model
Masking
1,015 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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