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

Novartis

Status and phase: Completed; Phase 3

Conditions: Seasonal Influenza

Treatments: Biological: TIVf; Biological: Comparator TIV; Biological: TIV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01209780

V71_18

Details and patient eligibility

About

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.

Enrollment: 3,116 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,116 participants in 4 patient groups

TIV (3-8 years)

Experimental group

Description:

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

Treatment:

Biological: TIV

Control TIV (3-8 years)

Active Comparator group

Description:

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.

Treatment:

Biological: Comparator TIV

Biological: TIVf

TIV ( 9-17 years)

Experimental group

Description:

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

Treatment:

Biological: TIV

Control TIV ( (9-17 years)

Active Comparator group

Description:

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

Treatment:

Biological: TIVf