A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

Launched by MERCK SHARP & DOHME LLC · Nov 18, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • 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