Clinical Trials Logo
  1. Home
  2. Influenza
  3. NCT02871206
  4. Details
NCT02871206 Clinical Trial

Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

Influenza Clinical Trial

Official title:
A Randomized Controlled Trial of Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02871206
Other study ID # AV-IIV
Secondary ID
Status Recruiting
Phase Phase 4
First received August 15, 2016
Last updated January 6, 2017
Start date November 2016

Study information
Verified date January 2017
Source McMaster University
Contact Mark Loeb, MD, MSc.
Phone 905-525-9140
Email loebm@mcmaster.ca
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health Canada
Study type Interventional

Clinical Trial Summary

This study is a randomized controlled trial (RCT) comparing adjuvanted influenza vaccine (AV) to unadjuvanted inactivated influenza vaccine (IIV). Children in Hutterite colonies in Alberta and Saskatchewan will receive AV or IIV. The goal of this study is to determine whether the AV vaccine, can provide increased community-wide protection.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 72 Months
Eligibility Group A: Receive Intervention

Inclusion Criteria:

- Healthy children aged 6 months to 72 months

Exclusion Criteria:

- Anaphylactic reaction to a previous dose of influenza vaccine or to any of its components

- Known Immunoglobulin E (IgE)-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock

- Guillain- Barré syndrome within eight weeks of a previous influenza vaccine

- Use of aspirin or salicylate- containing products within 30 days before enrollment

Group B:

Inclusion Criteria:

- Household members of children in Group A

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

Intervention

Biological:
• Fluad

• Fluzone

Locations
Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (3)
Lead Sponsor Collaborator
McMaster University University of Calgary, University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Laboratory-confirmed influenza infection Up to 3 years No
See also
  Status Clinical Trial Phase
Completed NCT05523089 - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults Phase 2
Completed NCT05009251 - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake N/A
Completed NCT03282240 - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US Phase 3
Completed NCT00971425 - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1) Phase 3
Completed NCT00968539 - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT00968526 - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults Phase 3
Completed NCT05525494 - Patient Portal Flu Vaccine Reminders (5) N/A
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT04695717 - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam Phase 3
Completed NCT05012163 - Lottery Incentive Nudges to Increase Influenza Vaccinations N/A
Completed NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
Completed NCT04109222 - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively Phase 4
Completed NCT02587221 - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age Phase 3
Completed NCT03453801 - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection Phase 1
Completed NCT01440387 - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older Phase 3
Terminated NCT01195779 - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children Phase 2
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT00972517 - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children Phase 3
Completed NCT04570904 - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting NCT03331991 - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel N/A