Clinical Trials Directory

Trials / Completed

CompletedNCT01776554

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Pediatric Subjects.

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
662 (actual)
Sponsor
Novartis Vaccines · Industry
Sex
All
Age
6 Months – 17 Years
Healthy volunteers
Accepted

Summary

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.

Conditions

Interventions

TypeNameDescription
BIOLOGICALAdjuvanted H5N1 pandemic influenza vaccineComparison of two doses of aH5N1c vaccine

Timeline

Start date
2013-01-01
Primary completion
2013-06-01
Completion
2014-06-01
First posted
2013-01-28
Last updated
2019-01-16
Results posted
2015-04-20

Locations

12 sites across 2 countries: United States, Thailand

Source: ClinicalTrials.gov record NCT01776554. Inclusion in this directory is not an endorsement.