Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Live Attenuated Influenza Vaccine; Biological: Trivalent Inactivated Vaccine

• Registration Number: NCT01653015
• Lead Sponsor: McMaster University

Brief Summary

There is uncertainty about whether a live attenuated vaccine (LAIV) offers additional benefit over inactivated trivalent influenza vaccine (TIV) in providing indirect benefit to those who are unvaccinated through herd immunity. The goal of this randomized clinical trial is to determine whether immunizing children in Hutterite colonies with LAIV can provide increased community-wide protection over TIV. Children aged 3 to 15 years in Hutterite colonies from Alberta and Saskatchewan will be randomized to one of two regimens: TIV or LAIV. The primary outcome of this study will be laboratory-confirmed influenza as detected by PCR in all participants (i.e vaccine recipients and nonrecipients). Secondary outcomes will include influenza-like illness, hospitalization, pneumonia, death, antibiotic use, absenteeism.

Detailed Description

The goal of this study is to test whether immunizing children in Hutterite colonies with LAIV can significantly reduce laboratory-confirmed influenza in the entire community compared to TIV. We hypothesize that ≥70% uptake of LAIV compared to a similar uptake of TIV among healthy children and adolescents will reduce laboratory-confirmed influenza in LAIV colonies by 50% compared to TIV colonies. Other specific objectives are to determine if LAIV reduces influenza in the healthy children and adolescents immunized and if LAIV reduces the following relative to TIV in all participants: influenza-like illness, antimicrobial prescriptions, physician-diagnosed otitis media, school or work-related absenteeism, physician visits for respiratory illness, lower respiratory infection, pneumonia, hospitalizations, and death. We will assess reactogenicity in both study groups.

Study Timeline

• Study First Submitted: 2012-07-26
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Study Start: 2012-11
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4611

Inclusion Criteria

Not provided

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Exclusion Criteria

• there are no exclusion criteria for this category of participants

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza vaccine TIV	Live Attenuated Influenza Vaccine	Trivalent inactivated vaccine (TIV).
Influenza vaccine LAIV	Trivalent Inactivated Vaccine	Live attenuated influenza vaccine (LAIV).

Primary Outcome Measures

Name	Time	Method
Laboratory-confirmed influenza infection.	up to 3 years

Secondary Outcome Measures

Name	Time	Method
All cause deaths.	December to June each year for 3 years.
Influenza like illness.	December to June each year for 3 years.
Physician diagnosed otitis media.	December to June each year for 3 years.
All cause hospitalizations.	December to June each year for 3 years.
Antimicrobial prescriptions.	December to June each year for 3 years.
Lower respiratory infection or pneumonia.	December to June each year for 3 years.
Hospitalization for lower respiratory infection or pneumonia.	December to June each year for 3 years.
School or work related absenteeism.	December to June each year for 3 years.
Physician visits for respiratory illness.	December to June each year for 3 years.
Deaths due to lower respiratory infections or pneumonia.	December to June each year for 3 years.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada