Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine
NCT03391193 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301
Last updated 2022-04-25
Summary
The aim of the study is to to assess the immunogenicity and safety of a quadrivalent influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine in single-dose presentation, in children aged 6 months to 17 years.
Conditions
Interventions
- BIOLOGICAL
-
Multi-dose Quadrivalent Influenza Vaccine
0.5 mL, intramuscular
- BIOLOGICAL
-
Single-dose Quadrivalent Influenza Vaccine
0.5 mL, intramuscular
Sponsors & Collaborators
-
Sanofi Pasteur, a Sanofi Company
lead INDUSTRY
Principal Investigators
-
Medical Director · Sanofi Pasteur, a Sanofi Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-19
- Primary Completion
- 2018-03-28
- Completion
- 2018-08-25
Countries
- Mexico
Study Locations
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