A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Status: | Completed |
---|---|
Conditions: | Influenza |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 5 - 8 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | December 2014 |
A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent
Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
children aged 5 years to less than 9 years. Comparison will be made to a licensed
Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
2014/2015 influenza season in the US.
Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
children aged 5 years to less than 9 years. Comparison will be made to a licensed
Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
2014/2015 influenza season in the US.
Inclusion Criteria:
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing
and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination
(if warranted).
Exclusion Criteria:
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to
eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at
study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning
to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular,
topical or inhaled preparations) or have received such therapy within the 3 months
preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such
treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
We found this trial at
11
sites
Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials

Click here to add this to my saved trials
