A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (pPCV) in Adults

• Status: Completed
• Trial end date: 2021-07-12
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of pPCV when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: pPCV 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 pPCV at 30 days postvaccination are statistically significantly greater following vaccination with pPCV than those following vaccination with Pneumovax™23.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine

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