Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Yoa

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT01209780

First received: September 24, 2010

Last updated: December 13, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 24, 2010
Last Updated Date	December 13, 2011
Start Date ^ICMJE	September 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 24, 2010)	Immunogenicity [ Time Frame: Day 22 (+5) for non-naive subjects; Day 50 (+5) for naive subjects ] [ Designated as safety issue: No ] To demonstrate the non-inferiority of the antibody responses of trivalent subunit inactivated flu test vaccine when compared to US licensed trivalent inactivated flu control vaccines 21 days after last vaccination in children ages 3 to 8 years
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01209780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 24, 2010)	Safety [ Time Frame: Day 180 (-7/+14) for non-naive subjects; Day 209 (-7/+14) for naive subjects ] [ Designated as safety issue: Yes ] To evaluate the safety and tolerability of trivalent subunit inactivated flu test vaccine and comparator in children and adolescents 3 to 17 years
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Yoa
Official Title ^ICMJE	A Multi-center, ph III, Randomized, Observer Blind Study to Evaluate the Safety and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Seasonal Influenza
Intervention ^ICMJE	Biological: subunit trivalent inactivated flu vaccine Non-Naive subjects will be randomized to receive a single IM injection of trivalent flu test vaccine or the flu control vaccine; naive subjects will be randomized to receive two IM vaccination doses 3 weeks apart of trivalent flu test vaccine or the flu control vaccine
Study Arm (s)	Experimental: investigational subunit trivalent inactivated flu vaccine Non-Naive subjects will be randomized to receive a single IM injection of trivalent flu test vaccine Naive subjects will be randomized to receive two IM vaccination doses 3 weeks apart of trivalent flu test vaccine Intervention: Biological: subunit trivalent inactivated flu vaccine Active Comparator: control subunit trivalent inactivated flu vaccine Non-Naive subjects will be randomized to receive a single IM injection of trivalent flu control vaccine Naive subjects will be randomized to receive two IM vaccination doses 3 weeks apart of trivalent flu control vaccine Intervention: Biological: subunit trivalent inactivated flu vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3116
Completion Date	September 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females 3 to 17 yrs of age 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 yrs of age and older, informed assent to participate in the study after the nature of the study has been explained to them in terms they can understand Individuals and parents/guardians are able to comply with all study procedures and are available for all clinic visits scheduled in the study Exclusion Criteria: Parents or legal guardians and individuals providing assent 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 interfere with the subject's ability to participate in the study Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose 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 Receipt 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
Gender	Both
Ages	3 Years to 17 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Colombia, Mexico, Panama, Philippines

Administrative Information
NCT Number ^ICMJE	NCT01209780
Other Study ID Numbers ^ICMJE	V71_18
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ^ICMJE	Novartis Vaccines
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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