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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

NCT01992107

Influenza

COMPLETED PHASE3

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

NCT01857206

Influenza Fever

COMPLETED PHASE3

Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

NCT02035696

Influenza

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

NCT01998477

Influenza

COMPLETED PHASE3

Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

NCT00464672

Influenza

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seasonal Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TIV (3-8 years)

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

Group Type EXPERIMENTAL

TIV

Intervention Type BIOLOGICAL

Investigational egg-derived trivalent subunit influenza vaccine.

Control TIV (3-8 years)

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.

Group Type ACTIVE_COMPARATOR

TIVf

Intervention Type BIOLOGICAL

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

Comparator TIV

Intervention Type BIOLOGICAL

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

TIV ( 9-17 years)

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

Group Type EXPERIMENTAL

TIV

Intervention Type BIOLOGICAL

Investigational egg-derived trivalent subunit influenza vaccine.

Control TIV ( (9-17 years)

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

Group Type ACTIVE_COMPARATOR

TIVf

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TIV

Investigational egg-derived trivalent subunit influenza vaccine.

Intervention Type BIOLOGICAL

TIVf

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

Intervention Type BIOLOGICAL

Comparator TIV

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes