Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
| Status: | Completed |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 4 - 18 |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | August 2014 |
A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years
Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than
4 years old to less than 18 years old.
4 years old to less than 18 years old.
Inclusion Criteria:
1. Male or female aged 4 years to less than 18 years of age.
2. Individual who had a parent or guardian who could give written informed consent after
understanding the nature of the study and comply with study procedures and were
available for follow-up.
3. If the individual was of an age where, according to local regulations, informed
assent is required, that individual had provided assent to participate in the study.
Exclusion Criteria:
1. Individuals recently vaccinated against influenza
2. Subjects with contraindications to receive influenza vaccine
We found this trial at
90
sites
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