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

Novartis

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Influenza Trivalent Inactivated vaccines Novartis

Biological: Influenza Trivalent Inactivated vaccines

Study type

Interventional

Funder types

Industry

Identifiers

NCT00649883

V70P6

Details and patient eligibility

About

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 aged 6 to <60 months.

Enrollment

360 patients

Sex

All

Ages

6 to 59 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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