Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pneumonia, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 3/29/2019 |
| Start Date: | August 29, 2018 |
| End Date: | March 28, 2019 |
A PHASE 1B, RANDOMIZED, CONTROLLED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINES IN HEALTHY JAPANESE ADULTS 18 TO 49 YEARS OF AGE
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal
conjugate vaccine formulations in healthy Japanese adults in the United States.
conjugate vaccine formulations in healthy Japanese adults in the United States.
Inclusion Criteria:
- Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in
Japan, with both parents and 4 grandparents who wer born in Japan (family tree by
history), and who have not lived outside of Japan for more than 5 years total
(confirmed by passport or interview)
Exclusion Criteria:
- Participation in other studies involving investigational drug(s), investigational
vaccines, or investigational medical devised within 28 days prior to study entry
and/or during study participation. Participation in purely observational studies is
acceptable.
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