ImmunityNCT07815925
Childhood Infection and Immunity Longitudinal Cohort
An observational study of Immunity and Respiratory Infection, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.
Trial summary
This prospective observational study will enroll approximately 1,200 children from birth through 7 years of age in Zhejiang Province, China. Participants will include general healthy children from the community, children with a history of serious or recurrent infections, and children with confirmed or highly suspected… Read more about this study
- Who is it for?
- Ages 0 days to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity, Respiratory Infection, Asthma
- Type of treatment
- Vaccines
- How many people
- 1,200 participants
- Where
- 2 sitesChina
- Study dates
- 10 Sep 2026to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of approximately 1,200 children from birth through 7 years of age who reside in the participating study areas in Zhejiang Province, China, and are available for long-term follow-up. Participants will be recruited from community settings and participating healthcare institutions into three predefined cohorts: approximately 600 children from the general community without known serious underlying disease, 400 children with a history of infection-related hospitalization or recurrent respiratory infections, and 200 children with physician-confirmed asthma. Recruitment targets will be stratified by age, with efforts to maintain reasonable balance by sex and urban or rural residence.
Who may be able to join
- Children from birth through 7 years of age (younger than 8 years at enrollment).
- The participant's parent or legal guardian is able to understand the study, voluntarily agrees to participation, and provides written informed consent.
- The participant resides in the study area and is expected to be available for long-term follow-up.
- For the General Community Cohort: no known serious underlying disease before enrollment.
- For the Infection Observation Cohort: either a history of hospitalization for an infectious disease before 3 years of age, with documented information on the pathogen, infection site, or clinical diagnosis; or at least three healthcare visits for respiratory infections during the 12 months before enrollment.
- For the Childhood Asthma Cohort: physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific criteria. Children younger than 1 year will not be included in this cohort.
Who cannot join
- An acute illness within 14 days before enrollment, including respiratory, gastrointestinal, dermatologic, or urinary symptoms or conditions specified in the protocol.
- Known primary immunodeficiency, malignant tumor, serious congenital disorder, or another condition that may substantially alter immune status.
- Long-term use of immunosuppressive or other immunomodulatory medications, defined as continuous or intermittent use for a cumulative duration of at least 3 months.
- A diagnosed coagulation abnormality or bleeding disorder, including coagulation factor deficiency, other coagulation disorders, or platelet abnormalities.
- Any other condition that, in the investigator's judgment, makes the child unsuitable for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tianying Zhang, PhD contact
China2 sites
Dongyang Center for Disease Control and Prevention
Dongyang, Zhejiang, 322100
Bin Guo, Master, +86-579-86655600, 534063265@qq.com
Yiwu Center for Disease Control and Prevention
Yiwu, Zhejiang, 322000
Jun Jiang, Master, +86-579-89938190, 271477702@qq.com
About this study
Official title: Childhood Infection and Immunity Longitudinal Cohort (KIDTRACE)
This prospective observational study will enroll approximately 1,200 children from birth through 7 years of age in Zhejiang Province, China. Participants will include general healthy children from the community, children with a history of serious or recurrent infections, and children with confirmed or highly suspected asthma. No treatment will be assigned by the researchers.
Health information will be collected through questionnaires, vaccination and medical records, regular follow-up, and active surveillance of respiratory infections. Blood, stool, and nasopharyngeal swab samples will be collected at enrollment and annual visits. Additional blood and respiratory samples will be collected during selected respiratory infection events.
Read more
Laboratory assessments may include antibody, pathogen, microbiome, and single-cell analyses. The study aims to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.
Xiamen University, Zhejiang Provincial Center for Disease Control and Prevention, and Xiang An Biomedicine Laboratory are the co-sponsors of this study. Hanqing He (Zhejiang Provincial CDC) and Tianying Zhang (Xiamen University) serve as the co-principal investigators.
Read the detailed description
This prospective observational cohort study combines scheduled longitudinal assessments, active surveillance of respiratory infections, healthcare data linkage, and biospecimen-based laboratory analyses to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.
Questionnaire data and biological samples will be collected at baseline and annual visits. Respiratory infection events will be monitored through regular contact with participants' families, voluntary symptom reporting, sentinel hospital surveillance, and available healthcare records. Remote follow-up will generally occur every 8 to 12 weeks and may increase to every 4 weeks during periods of increased respiratory pathogen activity.
Eligible respiratory infection events will trigger acute-phase sampling, preferably within 3 days after illness onset or at the initial clinical visit, and recovery-phase sampling at 21 ± 4 days after onset. All eligible respiratory infection-related hospitalizations will trigger sampling. Outpatient or emergency department events may trigger sampling no more than twice per participant per year, with an interval of at least 6 weeks between events.
Laboratory assessments may include vaccine- and pathogen-specific antibodies, respiratory pathogen detection, cytokines, gut microbiome analysis, genomic analysis, and selected single-cell analyses.
- Conditions
- Immunity, Respiratory Infection, Asthma
- Keywords
- Childhood Immunity, Immune Development, Infectious Disease Surveillance, asthma, respiratory infection
- Medical subject headings
- Respiratory Tract Infections, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Community Cohort | Approximately 600 children aged 0-7 years recruited from the general community who have no known serious underlying disease at enrollment. Participants will undergo questionnaires, longitudinal health surveillance, medical and vaccination record collection, and scheduled biospecimen collection. No intervention will be assigned. | |
| Infection Observation Cohort | Approximately 400 children aged 0-7 years who either had an infection-related hospitalization before 3 years of age with documented information on the pathogen, infection site, or clinical diagnosis, or had at least three healthcare visits for respiratory infections during the 12 months before enrollment. Participants will undergo the same observational follow-up and biospecimen collection procedures. No intervention will be assigned. | |
| Childhood Asthma Cohort | Approximately 200 children aged 1 through 7 years with physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific clinical criteria. No intervention will be assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory infection-related healthcare visit or hospitalization events
Multiplex respiratory pathogen PCR assay
Measured: From enrollment through 48 months
Transcriptional profiles of peripheral blood mononuclear cells (PBMCs)
Single-cell RNA sequencing and analysis will be performed on PBMCs collected at the annual study visits.
Measured: Baseline, 12, 24, 36 and 48 months
Secondary outcomes (3)
Vaccine-induced antibody response
Antibody levels against hepatitis B, pertussis, and varicella vaccine antigens will be measured in samples collected at the annual study visits.
Measured: Baseline and 12, 24, 36, and 48 months
Antibody levels against respiratory pathogens
Respiratory syncytial virus (RSV) neutralizing antibodies, Humanmetapneumovirus (HMPV) neutralizing antibodies, Parainfluenza virus (PIV) neutralizing antibodies, and Mycoplasma pneumoniae IgG will be measured in samples collected at the annual study visits.
Measured: Baseline and 12, 24, 36, and 48 months
Gut Microbiome Diversity
Metagenomic sequencing will be performed on stool samples collected at the annual study visits.
Measured: Baseline and 12, 24, 36, and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Collaborators
- Xiamen University, Xiang An Biomedicine Laboratory
- Responsible party
- Sponsor
- Investigators
- Jun Zhang, Master, Study chair, Xiamen UniversityHanqing He, PhD, Principal investigator, Zhejiang Provincial Center for Disease Control and PreventionTianying Zhang, PhD, Principal investigator, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815925
- Sponsor's protocol ID
- K-2026-065-01
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Infection and Immunity Longitudinal Cohort (KIDTRACE)
- ClinicalTrials.gov ID
- NCT07815925
- Acronym / sponsor ID
- K-2026-065-01
- Conditions
- Immunity, Respiratory Infection, Asthma
- Keywords
- Childhood Immunity, Immune Development, Infectious Disease Surveillance, asthma, respiratory infection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Collaborators
- Xiamen University, Xiang An Biomedicine Laboratory
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will enroll approximately 1,200 children from birth through 7 years of age in Zhejiang Province, China. Participants will include general healthy children from the community, children with a history of serious or recurrent infections, and children with confirmed or highly suspected asthma. No treatment will be assigned by the researchers.
Health information will be collected through questionnaires, vaccination and medical records, regular follow-up, and active surveillance of respiratory infections. Blood, stool, and nasopharyngeal swab samples will be collected at enrollment and annual visits. Additional blood and respiratory samples will be collected during selected respiratory infection events.
Laboratory assessments may include antibody, pathogen, microbiome, and single-cell analyses. The study aims to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.
Xiamen University, Zhejiang Provincial Center for Disease Control and Prevention, and Xiang An Biomedicine Laboratory are the co-sponsors of this study. Hanqing He (Zhejiang Provincial CDC) and Tianying Zhang (Xiamen University) serve as the co-principal investigators.
Detailed description
This prospective observational cohort study combines scheduled longitudinal assessments, active surveillance of respiratory infections, healthcare data linkage, and biospecimen-based laboratory analyses to characterize biomarkers of anti-infective immunity in children and assess their risk of infection.
Questionnaire data and biological samples will be collected at baseline and annual visits. Respiratory infection events will be monitored through regular contact with participants' families, voluntary symptom reporting, sentinel hospital surveillance, and available healthcare records. Remote follow-up will generally occur every 8 to 12 weeks and may increase to every 4 weeks during periods of increased respiratory pathogen activity.
Eligible respiratory infection events will trigger acute-phase sampling, preferably within 3 days after illness onset or at the initial clinical visit, and recovery-phase sampling at 21 ± 4 days after onset. All eligible respiratory infection-related hospitalizations will trigger sampling. Outpatient or emergency department events may trigger sampling no more than twice per participant per year, with an interval of at least 6 weeks between events.
Laboratory assessments may include vaccine- and pathogen-specific antibodies, respiratory pathogen detection, cytokines, gut microbiome analysis, genomic analysis, and selected single-cell analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Community Cohort | – | –Approximately 600 children aged 0-7 years recruited from the general community who have no known serious underlying disease at enrollment. Participants will undergo questionnaires, longitudinal health surveillance, medical and vaccination record collection, and scheduled biospecimen collection. No intervention will be assigned. |
| Infection Observation Cohort | – | –Approximately 400 children aged 0-7 years who either had an infection-related hospitalization before 3 years of age with documented information on the pathogen, infection site, or clinical diagnosis, or had at least three healthcare visits for respiratory infections during the 12 months before enrollment. Participants will undergo the same observational follow-up and biospecimen collection procedures. No intervention will be assigned. |
| Childhood Asthma Cohort | – | –Approximately 200 children aged 1 through 7 years with physician-confirmed asthma or highly suspected asthma according to the protocol-defined age-specific clinical criteria. No intervention will be assigned. |
Who may qualify
- Ages
- 0 days to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of approximately 1,200 children from birth through 7 years of age who reside in the participating study areas in Zhejiang Province, China, and are available for long-term follow-up. Participants will be recruited from community settings and participating healthcare institutions into three predefined cohorts: approximately 600 children from the general community without known serious underlying disease, 400 children with a history of infection-related hospitalization or recurrent respiratory infections, and 200 children with physician-confirmed asthma. Recruitment targets will be stratified by age, with efforts to maintain reasonable balance by sex and urban or rural residence.
Key inclusion criteria (6 listed)
- Children from birth through 7 years of age (younger than 8 years at enrollment).
- The participant's parent or legal guardian is able to understand the study, voluntarily agrees to participation, and provides written informed consent.
- The participant resides in the study area and is expected to be available for long-term follow-up.
- For the General Community Cohort: no known serious underlying disease before enrollment.
- For the Infection Observation Cohort: either a history of hospitalization for an infectious disease before 3 years of age, with documented information on the pathogen, infection site, or clinical diagnosis; or at least three healthcare visits for respiratory infections during the 12 months before enrollment.
Key exclusion criteria (5 listed)
- An acute illness within 14 days before enrollment, including respiratory, gastrointestinal, dermatologic, or urinary symptoms or conditions specified in the protocol.
- Known primary immunodeficiency, malignant tumor, serious congenital disorder, or another condition that may substantially alter immune status.
- Long-term use of immunosuppressive or other immunomodulatory medications, defined as continuous or intermittent use for a cumulative duration of at least 3 months.
- A diagnosed coagulation abnormality or bleeding disorder, including coagulation factor deficiency, other coagulation disorders, or platelet abnormalities.
- Any other condition that, in the investigator's judgment, makes the child unsuitable for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory infection-related healthcare visit or hospitalization events
Time frame: From enrollment through 48 months
Multiplex respiratory pathogen PCR assay
Transcriptional profiles of peripheral blood mononuclear cells (PBMCs)
Time frame: Baseline, 12, 24, 36 and 48 months
Single-cell RNA sequencing and analysis will be performed on PBMCs collected at the annual study visits.
3 secondary outcomes
Vaccine-induced antibody response
Time frame: Baseline and 12, 24, 36, and 48 months
Antibody levels against respiratory pathogens
Time frame: Baseline and 12, 24, 36, and 48 months
Gut Microbiome Diversity
Time frame: Baseline and 12, 24, 36, and 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianying Zhang, PhD contact
Jun Zhang, Master study chair
Xiamen University
Hanqing He, PhD principal investigator
Zhejiang Provincial Center for Disease Control and Prevention
Tianying Zhang, PhD principal investigator
Xiamen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunity and Respiratory Infection, run by Zhejiang Provincial Center for Disease Control and Prevention at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanqing He, PhD (+86-571-87115170, hanqinghe@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory infection-related healthcare visit or hospitalization events (time frame: From enrollment through 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.