NCT01209780CompletedPhase 3
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
Novartis Vaccines19 sites in 4 countries3,116 target enrollmentStarted: September 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 3,116
- Locations
- 19
- Primary Endpoint
- Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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:
- •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
- •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
Outcomes
Primary Outcomes
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
Time Frame: Day 22 for non-naive/Day 50 for naive subjects
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
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
Time Frame: Day 22 for non-naive/Day 50 for naive subjects
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.
Secondary Outcomes
- 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)
- Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine(Day 1 to 180 (non-naive )/Day 1 to 209 (naive))
Investigators
Study Sites (19)
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