CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Canadian Immunization Research Network

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: aTIV Primer; Biological: QIV Primer; Biological: aTIV Booster; Biological: QIV Booster

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03669627

CT18

Details and patient eligibility

About

This study evaluates whether priming influenza naive infants, age six to 23 months, with a MF59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. All participants will receive a priming vaccine, either MF59-adjuvanted trivalent influenza vaccine (aTIV) or unadjuvanted quadrivalent influenza vaccine (QIV). For the booster shot the following year, two thirds of participants will receive QIV and one third will receive MF59-adjuvanted vaccine.

Full description

Children under 24 months of age suffer from an influenza burden (high morbidity and mortality) similar to that of the elderly, and have been identified as a high priority target for vaccination programs by Canada's National Advisory Committee on Immunization. There is evidence that a person's first exposure to influenza antigens may have long-term implications for protection.

This is a randomized, controlled, observer-blind study that will assign participants to one of three groups. Group 1 will receive MF59-adjuvanted influenza vaccine (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 2 will receive QIV (two doses one month apart) in the fall of year 1, followed by QIV (one dose) in the fall of year 2. Group 3 will receive MF59-adjuvanted IV (two doses one month apart) in the fall of year 1, followed by MF59-adjuvanted IV (one dose) in the fall of year 2.

Enrollment: 159 patients

Sex: All

Ages: 6 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parent/LAR is willing and able to give informed consent for participation in the trial.
• Male or Female, aged six months to 23 months.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion criteria

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
• Participant in another research trial involving an investigational product or medical device in the prior 12 weeks.
• Prior receipt of an influenza vaccine
• History of laboratory-confirmed influenza infection, by parent/LAR report
• Hypersensitivity to any vaccine component of products used in this study (see product monographs)
• Immunodeficiency or autoimmune disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 3 patient groups

Group 1: aTIV primer, QIV booster

Active Comparator group

Description:

Two doses (0.25 mL) aTIV (FLUAD )received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2.

Treatment:

Biological: QIV Booster

Biological: aTIV Primer

Group 2: QIV primer, QIV booster

Other group

Description:

Standard of care control group: Two doses (0.5 mL) QIV (Fluzone) received one month apart in year 1. One dose (0.5 mL) QIV (Fluzone) received as booster in year 2.

Treatment:

Biological: QIV Booster

Biological: QIV Primer

Group 3: aTIV primer, aTIV booster

Experimental group

Description:

This arm is experimental in that some participants will be receiving the MF59-adjuvanted TIV (FLUAD) in year two of the study, after the age of two years, which is off label. Two doses (0.25 mL) TIV (FLUAD) received one month apart in year 1. One dose (0.25 mL) TIV (FLUAD) received as booster in year 2.

Treatment:

Biological: aTIV Booster

Biological: aTIV Primer