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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03669627

Enrollment

159

Registered

2018-09-13

Start date

2018-11-01

Completion date

2021-07-21

Last updated

2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

infants, priming, Fluad, Fluzone

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.

Interventions

BIOLOGICALaTIV Primer

MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart

BIOLOGICALQIV Primer

Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart

BIOLOGICALaTIV Booster

MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2

BIOLOGICALQIV Booster

Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Masking description

Observer-blind

Intervention model description

Participants will be randomly assigned to one of three groups: Group 1 will receive aTIV as a primer and QIV as a booster, Group 2 will receive QIV as both primer and booster, and Group 3 will receive aTIV as both primer and booster.

Eligibility

Sex/Gender

ALL

Age

6 Months to 23 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire	Days 56, 180, 393, and 545	The Acceptability Questionnaire measures parental opinions about side effects of the study vaccines. There are four questions with a scale range evaluating degree of certainty and one open-ended question with a free text response. There is no total score.
Cell-Mediated Immunity	Days 0, 56, 180, 365, 393, 545	To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026