NCT03669627

CT18 Infant Influenza Priming Study in Vaccine Naive Infants

A Randomized Controlled Observer Blind Trial to Compare the Immunogenicity and Acceptability of a MF59-adjuvanted Influenza Vaccine Compared to an Inactivated Influenza Vaccine as a Preferred Influenza Vaccine Priming Strategy for Naive Infants 6 to <24 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Canadian Immunization Research Network · Network
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	aTIV Primer	MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
BIOLOGICAL	QIV Primer	Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
BIOLOGICAL	aTIV Booster	MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
BIOLOGICAL	QIV Booster	Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2018-09-13
• Last updated: 2023-03-28

Locations

4 sites across 1 country: Canada