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Completed

NCT Number: NCT01653015

Live Versus Inactivated Influenza Vaccine Study in Hutterite Children

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Group A:

Inclusion criteria

  • healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion criteria

  • anaphylactic reaction to a previous dose of LAIV or TIV
  • known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
  • history of asthma
  • medically diagnosed or treated wheezing within 42 days before enrollment
  • Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
  • anaphylactic reaction to gentamicin
  • anaphylactic reaction to gelatin
  • anaphylactic reaction to neomycin
  • anaphylactic reaction to arginine
  • pregnancy
  • household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
  • use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

Inclusion criteria

  • other Hutterite community members that are not in Group A

Exclusion criteria

  • there are no exclusion criteria for this category of participants

Treatment and study plan

Trivalent Inactivated Vaccine

Biological

Influenza vaccination, 0.5 ml dose administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose four weeks later.

Other names: VAXIGRIP by Sanofi Pasteur

Live attenuated influenza vaccine

Biological

Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.

Other names: FLUMIST by Mediummune.

Primary outcomes

  1. Laboratory-confirmed influenza infection.

    Time frame: up to 3 years

Secondary outcomes

  1. Influenza like illness.

    Time frame: December to June each year for 3 years.

  2. Physician diagnosed otitis media.

    Time frame: December to June each year for 3 years.

  3. Antimicrobial prescriptions.

    Time frame: December to June each year for 3 years.

  4. School or work related absenteeism.

    Time frame: December to June each year for 3 years.

  5. Physician visits for respiratory illness.

    Time frame: December to June each year for 3 years.

  6. Lower respiratory infection or pneumonia.

    Time frame: December to June each year for 3 years.

  7. Hospitalization for lower respiratory infection or pneumonia.

    Time frame: December to June each year for 3 years.

  8. All cause hospitalizations.

    Time frame: December to June each year for 3 years.

  9. Deaths due to lower respiratory infections or pneumonia.

    Time frame: December to June each year for 3 years.

  10. All cause deaths.

    Time frame: December to June each year for 3 years.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2012
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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