Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/28/2017 |
Start Date: | November 2013 |
End Date: | August 2016 |
A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus
Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months
of Age.
Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months
of Age.
Inclusion Criteria:
- Children, males and females, healthy or at high risk of complications from influenza,
between ≥6 months to <72 months of age
- Documented consent provided by the subject's parent(s)/legal guardian(s)
- Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study
procedures.
Exclusion Criteria:
- Children with history of allergy to vaccine components.
- Additional eligibility criteria may be discussed by contacting the site
We found this trial at
92
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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