Status:
COMPLETED
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
Lead Sponsor:
Novartis Vaccines
Conditions:
Seasonal Influenza
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.
Eligibility Criteria
Inclusion
- Males and females aged 3 to 17 years, in good health as determined by medical history, physical examination and clinical judgment of the investigator
- Documented consent provided by parents or legal guardians
- For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study had been explained to them in terms they could understand
- Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study
Exclusion
- Parents or legal guardians and individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study
- Parents or legal guardians and individuals providing assent who do not consent to the retention of the subject's serum samples after study completion
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study
- Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or posed additional risk to the subjects due to participation in the study
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, to any excipients, and to eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propiolactone, or nonoxynol-9
- History of any serious disease, such as:
- cancer
- history of serious chronic, rheumatologic, neurologic and hematologic diseases
- history of underlying medical condition such as inborn errors of metabolism
- Known or suspected impairment/alteration of immune function, including:
- chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
- receipt of immunostimulants within 60 days prior to Visit 1
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study
- HIV infection or HIV-related disease
- Pregnant or breast-feeding female and any positive or indeterminate pregnancy test
- Received an influenza vaccine within 6 months prior to Visit 1
- Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1
- Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
- Experienced a fever and/or any acute illness within 3 days prior to each study vaccination
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
3116 Patients enrolled
Trial Details
Trial ID
NCT01209780
Start Date
September 1 2010
End Date
September 1 2011
Last Update
March 11 2014
Active Locations (13)
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1
Centro de Atención e Investigación Medica - CAIMED
Carrera 42A # 17-50, Bogotá, Colombia
2
Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla
Estado de México, Mexico
3
Centro de Salud Magally Ruiz, Street Bolivar
Panama - La Chorrera, Panama
4
Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas
Panama City, Panama