Trial Outcomes & Findings for Safe Administration of Flu Vaccine to Egg Allergic Children (NCT NCT01264601)

Last Updated: 2017-10-26

Results Overview

After randomization, group 1 will receive a 10%/90% (or 20%/80% for 0.25ml) graded challenge of the age appropriate TIV dose, separated by 30 minutes for observation. Group 2 will receive a first dose consisting of normal saline at a volume equal to 10% of their age appropriate dose, and the second dose will consist of their full age appropriate dose as the "90%" equivalent, also separated by 30 minutes of observation. For children receiving a 0.25ml dose, a 20%/80% split will be used for ease of administration in drawing up the dose. All parties will report any adverse reactions occurring in the next 48 hours after vaccination that were not observed at the time of in office observation.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

48 hours

Results posted on

2017-10-26

Participant Flow

This study was conducted from October 2010 through March 2012 at the University of Michigan.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	17	14
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safe Administration of Flu Vaccine to Egg Allergic Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Dose n=17 Participants 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 n=14 Participants 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 n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	5.6 years STANDARD_DEVIATION 3.4 • n=5 Participants	6.3 years STANDARD_DEVIATION 5.1 • n=7 Participants	6.2 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Egg skin test wheal, median, mm	9 mm STANDARD_DEVIATION 3.4 • n=5 Participants	6 mm STANDARD_DEVIATION 4.2 • n=7 Participants	7 mm STANDARD_DEVIATION 3.5 • n=5 Participants
Prior TIV	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Prior H1N1 Vaccine	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
History of Anaphylaxis to Egg	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Baked Egg Tolerant	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Atopic Dermatitis	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Asthma	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Allergic Rhinitis	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Other Food Allergy	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Serum Specific IgE Egg White	5.3 Measured in kUA/L STANDARD_DEVIATION 23.6 • n=5 Participants	16.2 Measured in kUA/L STANDARD_DEVIATION 28.9 • n=7 Participants	10.2 Measured in kUA/L STANDARD_DEVIATION 25 • n=5 Participants
Serum Specific IgE Ovalbumin	4.52 kUA/L STANDARD_DEVIATION 25.2 • n=5 Participants	10.45 kUA/L STANDARD_DEVIATION 35.5 • n=7 Participants	7.1 kUA/L STANDARD_DEVIATION 25.2 • n=5 Participants
Serum Specific IgE Ovomucoid	2.83 kUA/L STANDARD_DEVIATION 28 • n=5 Participants	7 kUA/L STANDARD_DEVIATION 39.8 • n=7 Participants	4.32 kUA/L STANDARD_DEVIATION 24.4 • n=5 Participants
Localized Urticaria	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Systemic Urticaria	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Oral/Facial Angioedema	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Throat Itching	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Throat Swelling	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Stridor	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Cough	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Dyspnea	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Wheezing	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Hypotension	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Vomiting	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Abdominal Pain	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age at Diagnosis	12 months STANDARD_DEVIATION 19.5 • n=5 Participants	11 months STANDARD_DEVIATION 14.4 • n=7 Participants	12 months STANDARD_DEVIATION 17.6 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Single Dose n=17 Participants 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 n=14 Participants 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.
Categorical Reactivity to Vaccine as it Was Administered No systemic reactivity	17 Participants	14 Participants
Categorical Reactivity to Vaccine as it Was Administered Mild, transient, induration at injection site	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Because no participants had systemic/severe reactivity, there were no participants who were TIV intolerant, and therefore no meaningful analysis of correlation of baseline characteristics to intolerance could be performed. All Baseline Characteristics collected for the original purpose of such correlation are reported in Baseline Characteristics.

Rates of co-morbid allergic disease, size and magnitude of egg skin and ImmunoCAP tests, presence of other food allergy, and tolerance of "baked egg" will be assessed through a screening questionnaire and chart review, and compared between the groups to assess for any significant differences that may predict TIV tolerance.

Outcome measures

Outcome data not reported

Adverse Events

Single Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Graded Challenge

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Dose n=17 participants at risk 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 n=14 participants at risk 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.
Gastrointestinal disorders Vomiting	0.00% 0/17	7.1% 1/14 • Number of events 1
Cardiac disorders Tachycardia	0.00% 0/17	7.1% 1/14 • Number of events 1
Skin and subcutaneous tissue disorders Anaphylaxis	5.9% 1/17 • Number of events 1	0.00% 0/14

Additional Information

Matthew Greenhawt, MD, MBA

University of Michigan

Phone: 734/936-5634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place