Clinical Tolerance to a Live Attenuated Vaccine Against Influenza (Flumist®) in a Population Allergic to Eggs

NCT02142491 | Completed DMC

• 1 other identifier: FluMist240713
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to verify the clinical tolerance to the vaccine Flumist (intranasal live attenuated influenza vaccine) in a population of egg allergic children. More specifically, the investigators want to estimate the risk of severe allergic reaction arising within 24 hours following the vaccination of egg allergic with Flumist.

Conditions

Egg Allergy

Keywords

Egg allergy; live attenuated influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Anaphylactic reaction following the administration of the vaccine

  Observation period at hospital during one hour post vaccination. And Follow-up phone call 24 hours post vacciation.

Secondary Outcomes (1)

• Allergic reactions occuring in the 24 hours following the immunization with Flumist.

  Datas will be assessed following the period of immunization. 24 hours following the immunization

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population will be a group of 75 egg allergic children (2 to 17 years old) and a group of 75 non-allergic children (2 to 17 years old). Egg allergic children will be selected from the allergy clinic of a university children hospital and non-egg allergic children will be selected from the community.

You may qualify if:

• Egg allergic children

You may not qualify if:

• Uncontrolled asthma the day of immunization
• severe asthma treated by oral steroids or high dose of inhaled steroids
• urticaria on the day of immunization
• antihistamines taken in the previous 3 to 7 days of immunization
• acute disease on the day of immunization (fever,irritability, vomiting, diarrhea, pallor, cyanosis, diaphoresis, lethargy)
• immunosuppressed patients or health worker who should be in contact with immunosuppressed patients.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Institut National en Santé Publique du Québec: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Egg Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Anne Des Roches, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Gaston De Serres, MD

  Santé Publique du Québec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Allergist

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: May 20, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

CA (1)