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

NCT01209780 | Completed Phase 3 Results

• 1 other identifier: V71_18
• Study Type: interventional
• Target: 3,116
• Locations: 4 countries
• Sites: 13

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.

Conditions

Seasonal Influenza

Keywords

seasonal influenza, vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.

  Day 22 for non-naive/Day 50 for naive subjects

• Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine

  Day 22 for non-naive/Day 50 for naive

• Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.

  Day 1, Day 29, and Day 50

• Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine

  Day 29 and Day 50

• Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine

  Day 1 to 7 after vaccination

Study Arms (4)

TIV (3-8 years)

EXPERIMENTAL

Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV)

Biological: TIV

Control TIV (3-8 years)

ACTIVE COMPARATOR

Non-Naive subjects received one dose and Naive subjects received two doses, administered 4 weeks apart, of control vaccine. Subjects aged 3 to \<4 years and subjects aged 4 to 8 years received different control TIV.

Biological: TIVf; Biological: Comparator TIV

TIV ( 9-17 years)

EXPERIMENTAL

All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis.

Biological: TIV

Control TIV ( (9-17 years)

ACTIVE COMPARATOR

All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis.

Biological: TIVf

Interventions

TIV BIOLOGICAL

Investigational egg-derived trivalent subunit influenza vaccine.

TIV ( 9-17 years); TIV (3-8 years)

TIVf BIOLOGICAL

US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.

Control TIV ( (9-17 years); Control TIV (3-8 years)

Comparator TIV BIOLOGICAL

US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children \<4 years.

Control TIV (3-8 years)

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (13)

Centro de Atención e Investigación Medica - CAIMED

Carrera 42A # 17-50, Bogotá, Colombia

Location

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

Location

Centro de Salud Magally Ruiz, Street Bolivar

Panama - La Chorrera, Panama

Location

Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas

Panama City, Panama

Location

Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa

Panama City, Panama

Location

Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre

Panama City, Panama

Location

Philippine General Hospital

Taft Avenue, Manila, Manila, 1000, Philippines

Location

Research Institute for Tropical Medicine, Department of Health Compound

Filinvest Corporate City, Alabang, Muntinlupa City, 1781, Philippines

Location

Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City

Alabang, Muntinlupa City, 1781, Philippines

Location

University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard

Barangay Dona Imelda Quezon City, 1113, Philippines

Location

De La Salle Health Sciences Institute

Dasmarinas Cavite, 4115, Philippines

Location

Mary Chiles General Hospital, 667 Gastambide St. Sampaloc

Manila, 1008, Philippines

Location

Philippine Children's Medical Center, Quezon Avenue corner Agham Road

Quezon City, Philippines

Location

Limitations and Caveats

Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis.

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 11, 2014
• Results First Posted: March 11, 2014

Record last verified: 2014-02

Locations

CO (1); PA (4); PH (7); ME (1)