An observational study in Immunity, Respiratory Infection and Asthma, sponsored by Zhejiang Provincial Center for Disease Control and Prevention. Not yet recruiting at 2 sites in China. Open to participants aged 0 Days to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Zhejiang Provincial Center for Disease Control and Prevention · Observational
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.
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.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 350 across 184 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Zhejiang Provincial Center for Disease Control and Prevention is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Exclusion Criteria:
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Respiratory infection-related healthcare visit or hospitalization events
Multiplex respiratory pathogen PCR assay
Time frame: 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.
Time frame: Baseline, 12, 24, 36 and 48 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12, 24, 36, and 48 months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
Zhejiang Provincial Center for Disease Control and Prevention