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CompletedNCT01366846LEAP-OnUpdated Mar 10, 2017Results posted

Persistence of Oral Tolerance to Peanut

A Phase 2 interventional study of Avoidance of peanut in Eczema, Egg Allergy and Food Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United Kingdom. Open to participants aged 5 Years to 5 Years. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
556
Allocation
Non-randomized
Ages
5 Years to 5 Years
Sex
All
01

Study summary

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.

Read the detailed description

This is a two-sample comparison employing all available study participants in both arms of the LEAP (NCT00329784) study at visit 72. After obtaining informed consent, LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into this study, the LEAP-On (NCT01366846) Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B).

At V72, after 12 months of this new intervention, all participants will have skin prick testing (SPT), specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms). For participants who do not have an oral challenge or an oral challenge at V72 with a determinate outcome, the following criteria will be used to determine their outcome at V72:

  • If the participant is tolerant and has an IgE > 0.1 and/or SPT > 0 mm at V60, the participant will be considered non-evaluable and will not be included in the analysis.
  • For all other participants, the V60 outcome will be applied to the V72 outcome (last observation carried forward).

Predictive values of peanut-specific IgE and/or SPT will not be used in the LEAP-On study because participants in the peanut consumption arm in the LEAP study are tolerating peanuts despite having high IgE and/or SPT.

02

Conditions studied

  • Eczema
  • Egg Allergy
  • Food Allergy
  • Hypersensitivity

Keywords

  • Peanut
03

In context

Eczema

503 studies on the registry are indexed under Eczema; 89 are open to participants now.

This study's enrollment of 556 is above the median of 91 across 401 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.

Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.

Browse National Institute of Allergy and Infectious Diseases (NIAID) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP (ClinicalTrials.gov ID NCT00329784) Study criteria.
  • Parent or guardian willing to provide .

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to comply with study intervention and procedures.
  • Participation in other food allergy intervention trials.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
556 participants (actual)

Study arms

  • Experimental
    Peanut avoidance after continuous peanut consumption

    These participants were the peanut consumption group of the ITN032AD (LEAP) study

    Other: Avoidance of peanut

  • Experimental
    Continued peanut avoidance

    These participants were the peanut avoidance group of the ITN032AD (LEAP) study

    Other: Avoidance of peanut

Interventions

  • OtherAvoidance of peanut

    All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum

    At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

    Time frame: 72 months

  2. Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group

    At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

    Time frame: 72 months

  3. Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population

    At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.

    Time frame: 72 months

  4. Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population

    At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

    Time frame: 72 months

Secondary outcomes

  1. Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group

    At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

    Time frame: 60 months and 72 months

  2. Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population

    At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

    Time frame: 60 months and 72 months

07

Results

Posted Jan 6, 2017

Participant flow

From among those who completed the LEAP study (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), 556 subjects were recruited between 26 May 2011 and 6 June 2014 at Evelina Children's Hospital in London, UK.

Participant flow — Overall Study
MilestoneNegative Stratum - Continued Peanut Avoidance GroupNegative Stratum - Peanut Avoidance After Consumption GroupPositive Stratum - Continued Peanut Avoidance GroupPositive Stratum - Peanut Avoidance After Peanut Consumption G
Started2352284746
Completed2322244645
Not completed3411
Withdrew: Withdrawal by subject2000
Withdrew: Communication difficulties1401
Withdrew: Scheduling conflicts0010

Outcome measures

PrimaryNumber of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum

At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

Time frame:
72 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum
ParticipantsNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum347186
Statistical analysis
  • Negative Stratum - Peanut Avoidance Group vs Negative Stratum - Peanut Consumption Group · Chi-squared · p = <0.001
  • Positive Stratum - Peanut Avoidance Group vs Positive Stratum - Peanut Consumption Group · Chi-squared · p = 0.004
PrimaryNumber of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group

At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

Time frame:
72 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group
ParticipantsContinued Peanut Avoidance GroupPeanut Avoidance After Peanut Consumption Group
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group5213
Statistical analysis
  • Continued Peanut Avoidance Group vs Peanut Avoidance After Peanut Consumption Group · Chi-squared · p = <0.001
PrimaryNumber of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population

At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.

Time frame:
72 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population
ParticipantsNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population347186
Statistical analysis
  • Negative Stratum - Peanut Avoidance Group vs Negative Stratum - Peanut Consumption Group · Chi-squared · p = <0.001
  • Positive Stratum - Peanut Avoidance Group vs Positive Stratum - Peanut Consumption Group · Chi-squared · p = 0.027
PrimaryNumber of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population

At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

Time frame:
72 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population
ParticipantsContinued Peanut Avoidance GroupPeanut Avoidance After Peanut Consumption Group
Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population5213
Statistical analysis
  • Continued Peanut Avoidance Group vs Peanut Avoidance After Peanut Consumption Group · Chi-squared · p = <0.001
SecondaryNumber of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group

At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

Time frame:
60 months and 72 months
Reported as:
Count of participants · Participants
Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group
ParticipantsPeanut Avoidance After Peanut Consumption Group
Month 6010
Month 7213
Statistical analysis
  • Peanut Avoidance After Peanut Consumption Group · Exact McNemar · p = 0.250
SecondaryNumber of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population

At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.

Time frame:
60 months and 72 months
Reported as:
Count of participants · Participants
Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population
ParticipantsPeanut Avoidance After Peanut Consumption Group
Month 6010
Month 7213
Statistical analysis
  • Peanut Avoidance After Peanut Consumption Group · Exact McNemar · p = 0.250

Adverse events

Collected over 4 years, 3 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Negative Stratum - Peanut Avoidance Group—12/235 (5.1%)206/235 (87.7%)
Negative Stratum - Peanut Consumption Group—7/228 (3.1%)182/228 (79.8%)
Positive Stratum - Peanut Avoidance Group—3/47 (6.4%)45/47 (95.7%)
Positive Stratum - Peanut Consumption Group—2/46 (4.3%)38/46 (82.6%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Anaphylactic reactionImmune system disorders2/2351/2282/472/46
AsthmaRespiratory, thoracic and mediastinal disorders2/2352/2281/470/46
WheezingRespiratory, thoracic and mediastinal disorders3/2350/2280/470/46
TonsillitisInfections and infestations0/2351/2280/470/46
Thermal burnInjury, poisoning and procedural complications0/2351/2280/470/46
SynovitisMusculoskeletal and connective tissue disorders0/2351/2280/470/46
Cerebral infarctionNervous system disorders0/2351/2280/470/46
Abscess limbInfections and infestations1/2350/2280/470/46
Eczema infectedInfections and infestations1/2350/2280/470/46
Pneumonia viralInfections and infestations1/2350/2280/470/46
Most frequent other events
Showing 10 of 19
Most frequent other events
EventNegative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption Group
Food allergyImmune system disorders42/23526/22816/4713/46
EczemaSkin and subcutaneous tissue disorders61/23542/22814/479/46
Respiratory tract infectionInfections and infestations40/23539/22811/479/46
RhinitisInfections and infestations46/23541/2289/478/46
WheezingRespiratory, thoracic and mediastinal disorders18/23519/2288/473/46
AsthmaRespiratory, thoracic and mediastinal disorders32/23520/2284/477/46
Lower respiratory tract infectionInfections and infestations20/2357/2282/475/46
CoughRespiratory, thoracic and mediastinal disorders16/23514/2283/475/46
UrticariaSkin and subcutaneous tissue disorders5/23513/2285/472/46
GastroenteritisInfections and infestations23/23512/2284/474/46

Baseline characteristics

Intent-to-treat

Age, Customized
Age, Customized(Months)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Age in Months61.0 ± 3.4461.7 ± 4.1960.6 ± 3.7661.4 ± 4.9861.3 ± 3.93
Sex: Female, Male
Sex: Female, Male(Participants)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
Female851021418219
Male1501263328337
Region of Enrollment
Region of Enrollment(participants)Negative Stratum - Peanut Avoidance GroupNegative Stratum - Peanut Consumption GroupPositive Stratum - Peanut Avoidance GroupPositive Stratum - Peanut Consumption GroupTotal
United Kingdom2352284746556
08

Study locations

1 site
  • Evelina Children's Hospital
    London, SE1 7EH, United Kingdom
09

References and documents

Publications

  • Du Toit G, Roberts G, Sayre PH, Bahnson HT, Radulovic S, Santos AF, Brough HA, Phippard D, Basting M, Feeney M, Turcanu V, Sever ML, Gomez Lorenzo M, Plaut M, Lack G; LEAP Study Team. Randomized trial of peanut consumption in infants at risk for peanut allergy. N Engl J Med. 2015 Feb 26;372(9):803-13. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23. Erratum In: N Engl J Med. 2016 Jul 28;375(4):398. doi: 10.1056/NEJMx150044. PubMed 25705822 ↗
  • Santos AF, Du Toit G, Lack G. Is the use of epinephrine a good marker of severity of allergic reactions during oral food challenges? J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):429-30. doi: 10.1016/j.jaip.2014.12.009. No abstract available. PubMed 25956314 ↗
  • Gruchalla RS, Sampson HA. Preventing peanut allergy through early consumption--ready for prime time? N Engl J Med. 2015 Feb 26;372(9):875-7. doi: 10.1056/NEJMe1500186. Epub 2015 Feb 23. No abstract available. PubMed 25705823 ↗
  • Du Toit G, Sayre PH, Roberts G, Sever ML, Lawson K, Bahnson HT, Brough HA, Santos AF, Harris KM, Radulovic S, Basting M, Turcanu V, Plaut M, Lack G; Immune Tolerance Network LEAP-On Study Team. Effect of Avoidance on Peanut Allergy after Early Peanut Consumption. N Engl J Med. 2016 Apr 14;374(15):1435-43. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4. PubMed 26942922 ↗

Individual participant data

Plan to share: Yes — ITN049AD (LEAP-On) is a continuation of the ITN032AD LEAP Study. The plan is to share data in: 1.) ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2017, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2011
First posted
Jun 6, 2011
Start
May 2011
Primary completionActual
May 2015
CompletionActual
May 2015
Results first posted
Jan 6, 2017
Last update
Mar 10, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01366846
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)
Responsible party
Sponsor
First posted
Jun 6, 2011
Start date
May 2011
Primary completion
May 2015
Completion
May 2015
Results posted
Jan 6, 2017
Last update
Mar 10, 2017

Study contacts

Gideon Lack, MD
study chair · Evelina Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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