Clinical trial NCT01209780: Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
Official title: A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Influenza
Keywords: seasonal influenza, vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-27
Enrollment: 3116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

* 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 Criteria:

* 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:

  1. cancer
  2. history of serious chronic, rheumatologic, neurologic and hematologic diseases
  3. history of underlying medical condition such as inborn errors of metabolism
* Known or suspected impairment/alteration of immune function, including:

  1. chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
  2. receipt of immunostimulants within 60 days prior to Visit 1
  3. 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
  4. 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

Primary outcomes:
measure: Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
timeFrame: Day 22 for non-naive/Day 50 for naive subjects
measure: Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
timeFrame: Day 22 for non-naive/Day 50 for naive subjects
Secondary outcomes:
measure: Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
timeFrame: Day 22 for non-naive/Day 50 for naive subjects
measure: Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine
timeFrame: Day 22 for non-naive/Day 50 for naive
measure: Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.
timeFrame: Day 1, Day 29, and Day 50
measure: Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine
timeFrame: Day 29 and Day 50
measure: Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
timeFrame: Day 1 to 7 after vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
timeFrame: Day 1 to 180 (non-naive )/Day 1 to 209 (naive)
Other outcomes:
Locations:
city: Carrera 42A # 17-50, Bogotá
country: Colombia
facility: Centro de Atención e Investigación Medica - CAIMED
city: Estado de México
country: Mexico
facility: Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla
city: Panama - La Chorrera
country: Panama
facility: Centro de Salud Magally Ruiz, Street Bolivar
city: Panamá
country: Panama
facility: Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas
city: Panamá
country: Panama
facility: Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa
city: Panamá
country: Panama
facility: Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre
city: Taft Avenue, Manila
country: Philippines
facility: Philippine General Hospital
state: Manila
city: FILINVEST Corporate City, Alabang
country: Philippines
facility: Research Institute for Tropical Medicine, Department of Health Compound
state: Muntinlupa City
city: Alabang, Muntinlupa City
country: Philippines
facility: Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City
city: Barangay Dona Imelda Quezon City
country: Philippines
facility: University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard
city: Dasmarinas Cavite
country: Philippines
facility: De La Salle Health Sciences Institute
city: Manila
country: Philippines
facility: Mary Chiles General Hospital, 667 Gastambide St. Sampaloc
city: Quezon City
country: Philippines
facility: Philippine Children's Medical Center, Quezon Avenue corner Agham Road
Study officials:
References: