At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 206 enrolled
Drug / intervention
13-valent pneumococcal conjugate vaccinebiological
Likely dose
13-valent pneumococcal conjugate vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating 13-valent pneumococcal conjugate vaccine for Pneumococcal Infections. Completed, enrolled 206 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumococcal Infections
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJul 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedJun 27, 2018
Enrollment StartJul 12, 2018
Primary CompletionNov 16, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 8.0 years ago
Interventions
13-valent pneumococcal conjugate vaccinebiological
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.