drugset / Trial / NCT03480802

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)

NCT03480802

Phase 3 Completed 302 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.

Timeline

Start
2018-07-06
Primary completion
2019-09-16
Completion
2020-01-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Pneumovax 23 Vaccine 0.5 ml Intramuscular
Comparator Prevnar 13 Vaccine 0.5 ml
Subject V114 Vaccine 0.5 ml Intramuscular