Trial · NCT01264601
Safe Administration of Flu Vaccine to Egg Allergic Children
NCT01264601, Not applicable, Completed, University of Michigan; results first posted 2017-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safe Administration of Flu Vaccine to Egg Allergic Children. Trials, record NCT01264601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01264601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safe Administration of Flu Vaccine to Egg Allergic Children
- NCT number
- NCT01264601
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 31 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Egg Allergy
- Interventions
- Trivalent Influenza Vaccine
- First posted
- 2010-12-22
- Last updated
- 2017-10-26
- Results first posted
- 2017-10-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Categorical Reactivity to Vaccine as it Was Administered | 48 hours | 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. |
| Secondary | Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered | 6 months | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Categorical Reactivity to Vaccine as it Was Administered | 48 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Influence of Atopic Co-morbidities on Severe Reactivity to Vaccine as it Was Administered | 6 months | 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. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Categorical Reactivity to Vaccine as it Was Administered | Single Dose | No systemic reactivity | 17 | Participants | |
| Categorical Reactivity to Vaccine as it Was Administered | Graded Challenge | No systemic reactivity | 14 | Participants | |
| Categorical Reactivity to Vaccine as it Was Administered | Single Dose | Mild, transient, induration at injection site | 3 | Participants | |
| Categorical Reactivity to Vaccine as it Was Administered | Graded Challenge | Mild, transient, induration at injection site | 4 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Dose | 17 | |
| Overall Study | STARTED | Graded Challenge | 14 | |
| Overall Study | COMPLETED | Single Dose | 17 | |
| Overall Study | COMPLETED | Graded Challenge | 14 | |
| Overall Study | NOT COMPLETED | Single Dose | 0 | |
| Overall Study | NOT COMPLETED | Graded Challenge | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Single Dose | 0 | 17 | 0 |
| other | Vomiting | Gastrointestinal disorders | Graded Challenge | 1 | 14 | 1 |
| other | Tachycardia | Cardiac disorders | Single Dose | 0 | 17 | 0 |
| other | Tachycardia | Cardiac disorders | Graded Challenge | 1 | 14 | 1 |
| other | Anaphylaxis | Skin and subcutaneous tissue disorders | Single Dose | 1 | 17 | 1 |
| other | Anaphylaxis | Skin and subcutaneous tissue disorders | Graded Challenge | 0 | 14 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Dose | ||
| Total, all-cause mortality | Graded Challenge | ||
| Total, other adverse events | Single Dose | 1 | 17 |
| Total, other adverse events | Graded Challenge | 2 | 14 |
| Total, serious adverse events | Single Dose | 0 | 17 |
| Total, serious adverse events | Graded Challenge | 0 | 14 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Single Dose vs Graded Challenge: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01264601
GET https://conductscience.org/api/trials/v1/NCT01264601/registered