Status:
COMPLETED
Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
6-59 years
Phase:
PHASE2
Brief Summary
This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children a...
Eligibility Criteria
Inclusion
- Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
- In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
- Able to comply with all study procedure
Exclusion
- Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
- History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
- Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
- Bleeding diathesis;
- Surgery planned during the study period;
- Receipt of another investigational agent within 90 days
- Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
- Ever received two doses of an influenza vaccine before the study
- Receipt of an influenza vaccine within 6 months prior to Visit 1;
- Experienced a temperature 38.0°C within 3 days prior to Visit 1
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00649883
Start Date
January 1 2008
End Date
October 1 2008
Last Update
April 7 2017
Active Locations (5)
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1
Centro Clínico La Quinta
Guatemala City, Guatemala City, Guatemala
2
Clínicas Dr. Rafael Montiel
Guatemala City, Guatemala City, Guatemala
3
Dr. Carlos Fernando Grazioso Aragón
Guatemala City, Guatemala City, Guatemala
4
Fundación Pediátrica Guatemalteca
Guatemala City, Guatemala City, Guatemala