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Safe Administration of Flu Vaccine to Egg Allergic Children (SAFE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264601
First Posted: December 22, 2010
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American College of Allergy, Asthma and Immunology
Information provided by (Responsible Party):
Matthew Greenhawt, University of Michigan
Results First Submitted: July 31, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Egg Allergy
Intervention: Biological: Trivalent Influenza Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted from October 2010 through March 2012 at the University of Michigan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After informed consent process, parents filled out a questionnaire, detailing their child's history of past reactions to the ingestion of egg and any prior influenza vaccines. This information was verified by medical record review. In addition, the most recent egg skin test and serum egg protein specific IgE were also obtained.

Reporting Groups
  Description
Single Dose

This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.

Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3.

Graded Challenge

Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.

Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3.


Participant Flow:   Overall Study
    Single Dose   Graded Challenge
STARTED   17   14 
COMPLETED   17   14 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Single Dose

This arm will receive TIV as 2 doses, the first of which will be normal saline administered at approximately 10% of the total age appropriate dose volume, followed 30 minutes later by the full age appropriate dose. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.

Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3.

Graded Challenge

Subjects in this arm will receive TIV by standard 10%/90% 2-step graded challenge split of the age appropriate dose, separated by 30 minutes. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose.

Trivalent Influenza Vaccine : Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3.

Total Total of all reporting groups

Baseline Measures
   Single Dose   Graded Challenge   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   14   31 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      17 100.0%      14 100.0%      31 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.6  (3.4)   6.3  (5.1)   6.2  (4.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  41.2%      8  57.1%      15  48.4% 
Male      10  58.8%      6  42.9%      16  51.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   14   31 
Egg skin test wheal, median, mm 
[Units: Mm]
Median (Standard Deviation)
 9  (3.4)   6  (4.2)   7  (3.5) 
Prior TIV 
[Units: Participants]
Count of Participants
 12   11   23 
Prior H1N1 Vaccine 
[Units: Participants]
Count of Participants
 10   6   16 
History of Anaphylaxis to Egg 
[Units: Participants]
Count of Participants
 8   6   14 
Baked Egg Tolerant 
[Units: Participants]
Count of Participants
 5   5   10 
Atopic Dermatitis 
[Units: Participants]
Count of Participants
 8   10   18 
Asthma 
[Units: Participants]
Count of Participants
 7   4   11 
Allergic Rhinitis 
[Units: Participants]
Count of Participants
 3   5   8 
Other Food Allergy 
[Units: Participants]
Count of Participants
 12   7   19 
Serum Specific IgE Egg White 
[Units: Measured in kUA/L]
Median (Standard Deviation)
 5.3  (23.6)   16.2  (28.9)   10.2  (25) 
Serum Specific IgE Ovalbumin 
[Units: kUA/L]
Median (Standard Deviation)
 4.52  (25.2)   10.45  (35.5)   7.1  (25.2) 
Serum Specific IgE Ovomucoid 
[Units: kUA/L]
Median (Standard Deviation)
 2.83  (28)   7  (39.8)   4.32  (24.4) 
Localized Urticaria 
[Units: Participants]
Count of Participants
 6   5   11 
Systemic Urticaria 
[Units: Participants]
Count of Participants
 9   5   14 
Oral/Facial Angioedema 
[Units: Participants]
Count of Participants
 5   6   11 
Throat Itching 
[Units: Participants]
Count of Participants
 3   3   6 
Throat Swelling 
[Units: Participants]
Count of Participants
 1   2   3 
Stridor 
[Units: Participants]
Count of Participants
 2   1   3 
Cough 
[Units: Participants]
Count of Participants
 10   3   13 
Dyspnea 
[Units: Participants]
Count of Participants
 1   2   3 
Wheezing 
[Units: Participants]
Count of Participants
 2   2   4 
Hypotension 
[Units: Participants]
Count of Participants
 1   1   2 
Vomiting 
[Units: Participants]
Count of Participants
 10   9   19 
Abdominal Pain 
[Units: Participants]
Count of Participants
 2   3   5 
Age at Diagnosis 
[Units: Months]
Median (Standard Deviation)
 12  (19.5)   11  (14.4)   12  (17.6) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Categorical Reactivity to Vaccine as it Was Administered   [ Time Frame: 48 hours ]

2.  Secondary:   Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Matthew Greenhawt, MD, MBA
Organization: University of Michigan
phone: 734/936-5634
e-mail: mgreenha@umich.edu


Publications:
American Academy of Pediatrics. Influenza. In: Pickering LK, ed. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009:400-412. Available at: http://aapredbook.aappublications.org/cgi/content/full/2009/1/3.64. Accessed June 18, 2010.
Howe LE, Chernin A, Sanders GM. Administration of Influenza Vaccine to the Egg Allergic Child Under 36 Months (Abstract). J Allergy Clin Immunol 2010; 125:AB23.


Responsible Party: Matthew Greenhawt, University of Michigan
ClinicalTrials.gov Identifier: NCT01264601     History of Changes
Other Study ID Numbers: HUM 00038826
First Submitted: December 21, 2010
First Posted: December 22, 2010
Results First Submitted: July 31, 2017
Results First Posted: October 26, 2017
Last Update Posted: October 26, 2017