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

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: TIV2c; Biological: QIVc; Biological: TIV1c

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992107

V130_03

Details and patient eligibility

About

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Enrollment: 2,333 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female aged 4 years to less than 18 years of age.
2. Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
3. If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.

Exclusion criteria

1. Individuals recently vaccinated against influenza
2. Subjects with contraindications to receive influenza vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,333 participants in 3 patient groups

QIVc (≥4 to <18 years)

Experimental group

Description:

Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season

Treatment:

Biological: QIVc

TIV1c (≥4 to <18 years)

Active Comparator group

Description:

Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season

Treatment:

Biological: TIV1c

TIV2c (≥4 to <18 years)

Active Comparator group

Description:

Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014

Treatment:

Biological: TIV2c