Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants

NCT02367885 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2016-04-07

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.

Conditions

  • Influenza Infection

Interventions

DRUG

TAK-850 0.5 mL injection

TAK-850 injection

DRUG

TAK-850 0.25 mL injection

TAK-850 intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • General Manager · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02367885 on ClinicalTrials.gov