An Open-Label, Baseline-Controlled Study in Children and Adolescents Aged 6 Months â?? 17 Years to Assess the Immunogenicity, Reactogenicity and Safety of a Quadrivalent Influenza Vaccine in India

Abbott India Limited0 sites236 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Abbott India Limited
Enrollment: 236
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

January 31, 2019

Last Updated

4 years ago

Study Type

Interventional

Investigators

Sponsor

Abbott India Limited

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria:
•1\. Male and female subjects more than or equal to 6 months up to 17 years of age at the time of enrolment who the investigator believes that they and/or their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the subject diaries, return for follow\-up visits and be available for telephone contacts)
•2\. Subjects in stable health determined from medical history, physical examination and clinical judgment of the Investigator. Subjects may have underlying illnesses as long as their symptoms/signs are controlled. If at the time of enrolment, the subject has been on regular prescribed medication for at least 3 months for a preexisting condition, the dose must have been stable for at least 3 months preceding study vaccination
•3\. The subjects and/or subjectâ??s parent(s) or LAR(s) sign and date a written, informed consent form (ICF). An assent will also be obtained according to age appropriate specific regulations
•4\. Subjects who are 6\-24 months of age at Day1 should have been born at full term of pregnancy (more than or equal to 37 weeks) and with a birth weight more than or equal to 2\.5 kg

Exclusion Criteria

•1\. History of adverse reaction or hypersensitivity to influenza vaccines or its components, incl. egg, or chicken proteins
•2\. History of Guillain\-Barre syndrome, other progressive neurological diseases or seizures (subject who had a single uncomplicated febrile convulsion in the past could be included)
•3\. Any confirmed, acute or historic (within 6 months prior to enrollment), or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required)
•4\. Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) or laboratory\-confirmed influenza infection in the 6 months preceding the first study vaccination
•5\. Receipt of any vaccine (including routine childhood vaccines) within the preceding 30 days or planned vaccination during the study within 30 days after any study vaccine administration
•6\. Having fever and/or acute disease or infection on the day of first study vaccination (enrolment can be deferred for up to 2 weeks provided subject remains otherwise eligible). Fever is defined as a body temperature more than or equal to 38\.0 degree Celsius (measured by oral or rectal method, as applicable). Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator
•7\. Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune\-modifying medication (such as corticosteroids and monoclonal antibodies) during 3 months prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed
•8\. Receipt of immunoglobulins or any blood products within the 3 months preceding the first study vaccination and planned administration during the study period
•9\. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination
•10\. Being a solid organ or bone marrow/stem cell transplant recipient