Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza Disease

Treatments: Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV); Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV); Biological: Trivalent split influenza vaccine (TIV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01346592

V70_29

Details and patient eligibility

About

This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.

Enrollment: 6,104 patients

Sex: All

Ages: 6 to 72 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1.Children 6 months to 72 months of age.

Exclusion Criteria:Children

1. Who had been hospitalized at the time of enrollment
2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
3. Who had known impairment of the immune function
4. Who had fever interfering with normal daily activities at the time of enrollment
5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
6. Concomitant participation in another clinical study
7. Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,104 participants in 3 patient groups

aTIV (6 to <72 months)

Active Comparator group

Description:

Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29

Treatment:

Biological: MF59-adjuvanted trivalent influenza vaccine (aTIV)

Comparator TIV (6 to <72 months)

Active Comparator group

Description:

Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29

Treatment:

Biological: Licensed comparator trivalent split influenza vaccine (comparator TIV)

TIV (6 to <72 months)

Active Comparator group

Description:

Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to \<36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 \& 29

Treatment:

Biological: Trivalent split influenza vaccine (TIV)