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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01209780
Other study ID # V71_18
Secondary ID
Status Completed
Phase Phase 3
First received September 24, 2010
Last updated February 7, 2014
Start date September 2010
Est. completion date September 2011

Study information

Verified date February 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationPhilippines : Food and Drug AdministrationColombia: Instituto Nacional de Vigilancia de Medicamentos y AlimentosPanama: Instituto Conmemorativo Gorgas de Estudios en la SaludMexico: Comision Federal para la Protección contra Riesgos Sanitarios
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3116
Est. completion date September 2011
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 17 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
TIV
Investigational egg-derived trivalent subunit influenza vaccine.
TIVf
US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects =4 years.
Comparator TIV
US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.

Locations

Country Name City State
Colombia Centro de Atención e Investigación Medica - CAIMED Carrera 42A # 17-50, Bogotá
Mexico Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla Estado de México
Panama Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas Panamá
Panama Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa Panamá
Panama Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre Panamá
Panama Centro de Salud Magally Ruiz, Street Bolivar Panama - La Chorrera
Philippines Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City Alabang, Muntinlupa City
Philippines University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard Barangay Dona Imelda Quezon City
Philippines De La Salle Health Sciences Institute Dasmarinas Cavite
Philippines Research Institute for Tropical Medicine, Department of Health Compound FILINVEST Corporate City, Alabang Muntinlupa City
Philippines Mary Chiles General Hospital, 667 Gastambide St. Sampaloc Manila
Philippines Philippine Children's Medical Center, Quezon Avenue corner Agham Road Quezon City
Philippines Philippine General Hospital Taft Avenue, Manila Manila

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Colombia,  Mexico,  Panama,  Philippines, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.
Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer =1:40 or as a pre-vaccination HI titer =1:10 and at minimum four-fold rise in post-vaccination antibody titer
Day 22 for non-naive/Day 50 for naive subjects No
Primary Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children. Day 22 for non-naive/Day 50 for naive subjects No
Secondary Percentages of Subjects Achieving HI Titers =40 Following Vaccination With Investigational TIV or Control Vaccine. The percentages of 3 to 8 year old subjects achieving HI titers =40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.
This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers =40, is =70%.
Day 22 for non-naive/Day 50 for naive subjects No
Secondary Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is =40.
Day 22 for non-naive/Day 50 for naive No
Secondary Percentages of Vaccine-naive Children Achieving HI Titers =40 After Receiving Two Doses of Investigational TIV or Control Vaccine. The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers =40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).
This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers =40 is =70%, for each vaccine strain.
Day 1, Day 29, and Day 50 No
Secondary Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is =40, for each vaccine strain.
Day 29 and Day 50 No
Secondary Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported. Day 1 to 7 after vaccination Yes
Secondary Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported. Day 1 to 180 (non-naive )/Day 1 to 209 (naive) Yes
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