CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: QIV Primer; Biological: aTIV Primer; Biological: aTIV Booster; Biological: QIV Booster

• Registration Number: NCT03669627
• Lead Sponsor: Canadian Immunization Research Network

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-11-01
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: QIV primer, QIV booster	QIV Primer	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.
Group 1: aTIV primer, QIV booster	aTIV Primer	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.
Group 3: aTIV primer, aTIV booster	aTIV Primer	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.
Group 3: aTIV primer, aTIV booster	aTIV Booster	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.
Group 2: QIV primer, QIV booster	QIV Booster	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.
Group 1: aTIV primer, QIV booster	QIV Booster	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.

Primary Outcome Measures

Name	Time	Method
Serum hemagglutination inhibition (HI) antibody titers	Before and after priming with the various vaccine combinations at day 393.	Serum HI antibodies to influenza antigens A/H3N2, A/H1N1, and B Yamagata and Victoria lineages will be used to calculate the seroconversion rate and the seroprotection rates.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Days 0 to 545	Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.

Trial Locations

Locations (4)

Vaccine Evaluation Center, BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Research Institute of the McGill University health Centre; 🇨🇦 Montréal, Quebec, Canada

Équipe de recherche en vaccination CHU de Québec-Université Laval; 🇨🇦 Québec, Quebec, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada