Live Versus Inactivated Influenza Vaccine Study in Hutterite Children
This study is currently recruiting participants.
Verified February 2013 by McMaster University
Sponsor:
McMaster University
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01653015
First received: July 26, 2012
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Trivalent Inactivated Vaccine Biological: Live Attenuated Influenza Vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized Controlled Trial of Live Attenuated Vaccine Versus Trivalent Inactivated Vaccine in Hutterite Children |
Resource links provided by NLM:
Further study details as provided by McMaster University:
Primary Outcome Measures:
- Laboratory-confirmed influenza infection. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Influenza like illness. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Physician diagnosed otitis media. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Antimicrobial prescriptions. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- School or work related absenteeism. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Physician visits for respiratory illness. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Hospitalization for lower respiratory infection or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- All cause hospitalizations. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- Deaths due to lower respiratory infections or pneumonia. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
- All cause deaths. [ Time Frame: December to June each year for 3 years. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3800 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Influenza vaccine LAIV
Live attenuated influenza vaccine (LAIV).
|
Biological: Trivalent Inactivated Vaccine
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 Name: VAXIGRIP by Sanofi Pasteur
|
|
Active Comparator: Influenza vaccine TIV
Trivalent inactivated vaccine (TIV).
|
Biological: Live Attenuated Influenza Vaccine
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 Name: FLUMIST by Mediummune.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653015
Contacts
| Contact: Vanessa EA Manning, CCRA | 905-525-9140 ext 26678 | manninv@mcmaster.ca |
| Contact: Sasha Eskandarian | 905-525-9140 ext 26672 | eskand@mcmaster.ca |
Locations
| Canada, Ontario | |
| McMaster University | Recruiting |
| Hamilton, Ontario, Canada, L8S 4K1 | |
| Contact: Mark B Loeb, MD, MSc 905-525-9140 ext 26066 loebm@mcmaster.ca | |
| Contact: Vanessa EA Manning, CCRA 905-525-9140 ext 26678 manninv@mcmaster.ca | |
| Principal Investigator: Mark B Loeb, MD, MSc | |
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Mark B Loeb, MD, MSc | McMaster University |
More Information
No publications provided
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT01653015 History of Changes |
| Other Study ID Numbers: | RC1-274129 |
| Study First Received: | July 26, 2012 |
| Last Updated: | February 25, 2013 |
| Health Authority: | Canada: Health Canada Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013