Trials / Completed
CompletedNCT03571607
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO PNEUMOCOCCAL VACCINES
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 206 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 13-valent pneumococcal conjugate vaccine | A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1. |
Timeline
- Start date
- 2018-07-12
- Primary completion
- 2018-11-16
- Completion
- 2018-11-16
- First posted
- 2018-06-27
- Last updated
- 2020-02-18
- Results posted
- 2019-12-10
Locations
8 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03571607. Inclusion in this directory is not an endorsement.