Trial Outcomes & Findings for Safe Administration of Flu Vaccine to Egg Allergic Children (NCT NCT01264601)
NCT ID: 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.
COMPLETED
NA
31 participants
48 hours
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
| 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
| Measure |
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
|
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.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
17 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
6.3 years
STANDARD_DEVIATION 5.1 • n=107 Participants
|
6.2 years
STANDARD_DEVIATION 4.3 • n=206 Participants
|
5.6 years
STANDARD_DEVIATION 3.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
17 Participants
n=99 Participants
|
|
Egg skin test wheal, median, mm
|
6 mm
STANDARD_DEVIATION 4.2 • n=107 Participants
|
7 mm
STANDARD_DEVIATION 3.5 • n=206 Participants
|
9 mm
STANDARD_DEVIATION 3.4 • n=99 Participants
|
|
Prior TIV
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
12 Participants
n=99 Participants
|
|
Prior H1N1 Vaccine
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
10 Participants
n=99 Participants
|
|
History of Anaphylaxis to Egg
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
8 Participants
n=99 Participants
|
|
Baked Egg Tolerant
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
|
Atopic Dermatitis
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
8 Participants
n=99 Participants
|
|
Asthma
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
7 Participants
n=99 Participants
|
|
Allergic Rhinitis
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
3 Participants
n=99 Participants
|
|
Other Food Allergy
|
7 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
12 Participants
n=99 Participants
|
|
Serum Specific IgE Egg White
|
16.2 Measured in kUA/L
STANDARD_DEVIATION 28.9 • n=107 Participants
|
10.2 Measured in kUA/L
STANDARD_DEVIATION 25 • n=206 Participants
|
5.3 Measured in kUA/L
STANDARD_DEVIATION 23.6 • n=99 Participants
|
|
Serum Specific IgE Ovalbumin
|
10.45 kUA/L
STANDARD_DEVIATION 35.5 • n=107 Participants
|
7.1 kUA/L
STANDARD_DEVIATION 25.2 • n=206 Participants
|
4.52 kUA/L
STANDARD_DEVIATION 25.2 • n=99 Participants
|
|
Serum Specific IgE Ovomucoid
|
7 kUA/L
STANDARD_DEVIATION 39.8 • n=107 Participants
|
4.32 kUA/L
STANDARD_DEVIATION 24.4 • n=206 Participants
|
2.83 kUA/L
STANDARD_DEVIATION 28 • n=99 Participants
|
|
Localized Urticaria
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
6 Participants
n=99 Participants
|
|
Systemic Urticaria
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
9 Participants
n=99 Participants
|
|
Oral/Facial Angioedema
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
5 Participants
n=99 Participants
|
|
Throat Itching
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=99 Participants
|
|
Throat Swelling
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Stridor
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Cough
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
10 Participants
n=99 Participants
|
|
Dyspnea
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Wheezing
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Hypotension
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Vomiting
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
10 Participants
n=99 Participants
|
|
Abdominal Pain
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Age at Diagnosis
|
11 months
STANDARD_DEVIATION 14.4 • n=107 Participants
|
12 months
STANDARD_DEVIATION 17.6 • n=206 Participants
|
12 months
STANDARD_DEVIATION 19.5 • n=99 Participants
|
PRIMARY outcome
Timeframe: 48 hoursAfter 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.
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 monthsPopulation: 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
Graded Challenge
Serious adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place