Trial Outcomes & Findings for COVID-19: Human Epidemiology and Response to SARS-CoV-2 (NCT NCT04375761)

Last Updated: 2025-08-06

Results Overview

Nasal samples were analyzed to determine whether a participant ever tested positive for SARS-CoV-2 or not over the course of the study. Kaplan-Meier was used to estimate survival probabilities at timepoints throughout the study. Participants were censored if they did not test positive for SARS-CoV-2 by the end of follow-up. The last positive nasal swab occurred at day 212.

Recruitment status

COMPLETED

Target enrollment

5599 participants

Primary outcome timeframe

Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)

Results posted on

2025-08-06

Participant Flow

Participants were enrolled from 01May2022 through 17Dec2020. Children and teenagers who were participating in NIH-funded cohorts that focused on asthma and/or allergic disease were recruited. In addition to the cohort-participating child, enrollment required a household caregiver; an additional household child and adult could also be enrolled.

The study was performed remotely. Participants completed a registration form and questionnaires/surveys electronically. Participants did a web-based training that described sample collection and handling, teletraining, \& were provided written instructions. Study staff were available by phone, text, or video conferencing.The 2 main groups of interest in this study were "Index Participants" (the cohort-participating child) \& "All Participants Combined" (index participant and household contacts).

Participant milestones

Participant milestones
Measure	Index Participants Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".	Non-Index Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants excluding the index participants.
Overall Study STARTED	1387	2755
Overall Study COMPLETED	1012	2011
Overall Study NOT COMPLETED	375	744

Reasons for withdrawal

Reasons for withdrawal
Measure	Index Participants Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".	Non-Index Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants excluding the index participants.
Overall Study Death	1	2
Overall Study Lost to Follow-up	203	380
Overall Study Withdrawal by Subject	47	98
Overall Study Noncompliance with study procedure	121	251
Overall Study Reimbursement not enough	1	2
Overall Study Unforeseen family circumstances	1	3
Overall Study Test too painful	1	1
Overall Study Moved	0	2
Overall Study Nonresponsive	0	5

Baseline Characteristics

COVID-19: Human Epidemiology and Response to SARS-CoV-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Index Participants n=1387 Participants Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.	Non-Index Participants n=2755 Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.	Total n=4142 Participants Total of all reporting groups
Age, Continuous	10.3 years STANDARD_DEVIATION 4.9 • n=93 Participants	32.3 years STANDARD_DEVIATION 15.8 • n=4 Participants	25.0 years STANDARD_DEVIATION 16.8 • n=27 Participants
Sex/Gender, Customized Female	647 Participants n=93 Participants	1756 Participants n=4 Participants	2403 Participants n=27 Participants
Sex/Gender, Customized Male	734 Participants n=93 Participants	993 Participants n=4 Participants	1727 Participants n=27 Participants
Sex/Gender, Customized Intersex	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Sex/Gender, Customized Unknown or Not Reported	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	174 Participants n=93 Participants	302 Participants n=4 Participants	476 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1184 Participants n=93 Participants	2406 Participants n=4 Participants	3590 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	29 Participants n=93 Participants	47 Participants n=4 Participants	76 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	10 Participants n=93 Participants	20 Participants n=4 Participants	30 Participants n=27 Participants
Race (NIH/OMB) Asian	23 Participants n=93 Participants	55 Participants n=4 Participants	78 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Black or African American	320 Participants n=93 Participants	563 Participants n=4 Participants	883 Participants n=27 Participants
Race (NIH/OMB) White	851 Participants n=93 Participants	1854 Participants n=4 Participants	2705 Participants n=27 Participants
Race (NIH/OMB) More than one race	86 Participants n=93 Participants	83 Participants n=4 Participants	169 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	93 Participants n=93 Participants	177 Participants n=4 Participants	270 Participants n=27 Participants
Region of Enrollment United States	1387 participants n=93 Participants	2755 participants n=4 Participants	4142 participants n=27 Participants
Asthma Yes	528 Participants n=93 Participants	622 Participants n=4 Participants	1150 Participants n=27 Participants
Asthma No	859 Participants n=93 Participants	2133 Participants n=4 Participants	2992 Participants n=27 Participants
Food Allergies Yes	343 Participants n=93 Participants	306 Participants n=4 Participants	649 Participants n=27 Participants
Food Allergies No	1044 Participants n=93 Participants	2449 Participants n=4 Participants	3493 Participants n=27 Participants
Eczema Yes	386 Participants n=93 Participants	336 Participants n=4 Participants	722 Participants n=27 Participants
Eczema No	1001 Participants n=93 Participants	2419 Participants n=4 Participants	3420 Participants n=27 Participants
Allergies (hay fever, rhinitis) Yes	685 Participants n=93 Participants	1207 Participants n=4 Participants	1892 Participants n=27 Participants
Allergies (hay fever, rhinitis) No	702 Participants n=93 Participants	1548 Participants n=4 Participants	2250 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline through end of study (24 or 28 weeks, depending on if a participant agreed to do the extension)

Population: Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.

Outcome measures

Outcome measures
Measure	Index Participants n=1387 Participants Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".	Non-Index Participants n=2755 Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.	All Participants Combined n=4142 Participants A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 30 Days	98.9 Percent surviving using Kaplan-Meier Interval 98.4 to 99.1	99.2 Percent surviving using Kaplan-Meier Interval 98.8 to 99.5	99.1 Percent surviving using Kaplan-Meier Interval 98.8 to 99.4
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 60 Days	98.0 Percent surviving using Kaplan-Meier Interval 97.3 to 98.8	98.4 Percent surviving using Kaplan-Meier Interval 97.9 to 98.9	98.3 Percent surviving using Kaplan-Meier Interval 97.9 to 98.7
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 90 Days	97.2 Percent surviving using Kaplan-Meier Interval 96.3 to 98.1	97.7 Percent surviving using Kaplan-Meier Interval 97.1 to 98.3	97.5 Percent surviving using Kaplan-Meier Interval 97.0 to 98.0
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 120 Days	95.8 Percent surviving using Kaplan-Meier Interval 94.7 to 96.9	96.1 Percent surviving using Kaplan-Meier Interval 95.3 to 96.9	96.0 Percent surviving using Kaplan-Meier Interval 95.3 to 96.6
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 150 Days	94.2 Percent surviving using Kaplan-Meier Interval 92.9 to 95.6	94.3 Percent surviving using Kaplan-Meier Interval 93.3 to 95.2	94.3 Percent surviving using Kaplan-Meier Interval 93.5 to 95.1
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 180 Days	90.5 Percent surviving using Kaplan-Meier Interval 88.5 to 92.7	91.4 Percent surviving using Kaplan-Meier Interval 90.1 to 92.7	91.1 Percent surviving using Kaplan-Meier Interval 90.0 to 92.2
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 210 Days	90.1 Percent surviving using Kaplan-Meier Interval 87.9 to 92.4	88.4 Percent surviving using Kaplan-Meier Interval 85.3 to 91.7	89.0 Percent surviving using Kaplan-Meier Interval 86.8 to 91.3
Number of Index Participants and Their Household Contacts With SARS-CoV-2 RNA Detection in Nasal Samples Over the Study/Surveillance Period 212 Days	90.1 Percent surviving using Kaplan-Meier Interval 87.9 to 92.4	83.5 Percent surviving using Kaplan-Meier Interval 77.5 to 89.9	85.7 Percent surviving using Kaplan-Meier Interval 81.5 to 90.1

SECONDARY outcome

Timeframe: Up to Week 24

Included: Participants currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Testing method: Positive test result(s) for SARS-CoV-2 RNA in nasal samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, an average of 24 Weeks

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Outcome definition: Detectable SARS-CoV-2-specific antibodies in serum biological specimen(s).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Nasal samples of participants currently or previously enrolled in NIH-funded studies who fulfill inclusion criteria (index participant) and their family/household contacts that test positive for SARS-CoV-2, will undergo transcriptome analysis. Total RNA will be isolated for cDNA synthesis and amplification. Differential gene expression analysis be pursued.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Nasal samples of index participants that test positive for SARS-CoV-2 will be evaluated by transcriptome analysis. Differential gene expression analysis at different timepoints in the disease process will be analyzed. Definition of index participant(s): Prior and/or current NIH-funded clinical research study participant(s) who fulfill inclusion criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

An analysis of symptoms associated with positive SARS-CoV-2 RNA tests in nasal samples will be conducted. Included in analysis: Index participants and their household contacts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests: Positive for SARS-CoV-2 RNA in nasal samples

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 24

Index participants: Those currently or in the past enrolled in NIH-funded studies who fulfill inclusion criteria. Tests: Positive for SARS-CoV-2 RNA in nasal samples.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

An exploratory analysis will be conducted for detection of possible associations, focusing on baseline demographic and environment factors and/or history of bronchiolitis prior history with the cumulative incidence of SARS-CoV-2 detection in nasal samples Test: Positive for SARS-CoV-2 RNA in nasal samples.

Outcome measures

Outcome data not reported

Adverse Events

Index Participants

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Non-Index Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Index Participants n=1387 participants at risk Index participants are participants who are part of National Institutes of Health-funded cohorts that focused on asthma and/or allergic disease. This group will be index participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study. This group is a subset of the group "All Participants Combined".	Non-Index Participants n=2755 participants at risk A minimum of 2 family members (index participant and a caregiver) and a maximum of 4 total family members (additional caregiver and/or sibling) were enrolled per family. This group is all participants except Index Participants who enrolled in the study by completing the date on the electronic registration form and who also contributed at least 1 nasal swab while on study.
General disorders Vessel puncture site bruise	0.22% 3/1387 • Number of events 3 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
General disorders Vessel puncture site haemorrhage	0.07% 1/1387 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
General disorders Vessel puncture site hypoaesthesia	0.00% 0/1387 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.04% 1/2755 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
General disorders Vessel puncture site pain	0.07% 1/1387 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.04% 1/2755 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
General disorders Vessel puncture site rash	0.07% 1/1387 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
General disorders Vessel puncture site swelling	0.14% 2/1387 • Number of events 2 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Injury, poisoning and procedural complications Concussion	0.00% 0/1387 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.04% 1/2755 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Injury, poisoning and procedural complications Contusion	0.00% 0/1387 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.04% 1/2755 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1387 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.04% 1/2755 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Nervous system disorders Dizziness	0.14% 2/1387 • Number of events 2 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Nervous system disorders Syncope	0.29% 4/1387 • Number of events 4 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.07% 2/2755 • Number of events 2 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.14% 2/1387 • Number of events 2 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).
Skin and subcutaneous tissue disorders Dermatitis contact	0.07% 1/1387 • Number of events 1 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).	0.00% 0/2755 • Adverse events were collected from the time of first procedure, which occurred at study week 2, until a participant completed the study, until 48 hours after he/she prematurely withdrew, or is withdrawn from the study. Participants were followed for 24 or 28 weeks, or until they withdrew. Adverse events (including SAEs) were discovered by interviewing the participants through specific questions that were incorporated in the study questionnaires. Adverse events were also discovered if a participant had an unsolicited complaint. The two main groups of interest in this study were "Index Participants" (the cohort-participating child) and "All Participants Combined" (index participant and household contacts).

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place