A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.

pPCV-001

This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.

2019-12-06

2021-07-12

2021-07-12

Completed

Early phase I

600

Inclusion Criteria * Phase 1: * Male or female, from 18 years to 49 years of age inclusive * Phase 2: * Male or female ≥50 years of age Phase 1 and Phase 2 * Males: refrain from donating sperm, remain abstinent during study or agree to use condom * Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent Exclusion Criteria * History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening * Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine * Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease * Coagulation disorder contraindicating IM vaccination * Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\] or axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening * Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ \[eg, breast carcinoma, cervical cancer in situ\] that have undergone potentially curative therapy are not excluded) * Pregnant * Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol. * Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ACTUAL'}}

2022-09-16