CT18 Infant Influenza Priming Study in Vaccine Naive Infants

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669627
• Other study ID #: CT18
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2018
• Est. completion date: July 21, 2021

Study information

• Verified date: March 2023
• Source: Canadian Immunization Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
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	Vaccine Evaluation Center, BC Children's Hospital	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Canadian Immunization Research Network	Canadian Center for Vaccinology, CHU de Quebec-Universite Laval, Dalhousie University, McGill University Health Centre/Research Institute of the McGill University Health Centre, Provincial Health Services Authority, Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vaccine acceptability: parent/Legally Authorized Representative (LAR) questionnaire	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.	Days 56, 180, 393, and 545
Other	Cell-Mediated Immunity	To assess cell mediated immune responses to three influenza immunization two priming schedules in vaccine naïve infants.	Days 0, 56, 180, 365, 393, 545
Primary	Serum hemagglutination inhibition (HI) antibody titers	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.	Before and after priming with the various vaccine combinations at day 393.
Secondary	Adverse Events (AEs)	Measure local and systemic solicited and unsolicited adverse events following each vaccine dose, and severe AE throughout the study.	Days 0 to 545