Passive Transmission of Maternal and Infant AntibodiesNCT05851911
Passive Transmission of COVID-19 Antibody From Mother to Infant
An observational study of Passive Transmission of Maternal and Infant Antibodies, run by Children's Hospital of Chongqing Medical University at 1 site in China.
Trial summary
At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children… Read more about this study
- Who is it for?
- Ages 0 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Passive Transmission of Maternal and Infant Antibodies
- What is being tested?
- sars-cov-2 vaccine or infection
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Samples of infants not infected with COVID-19 and not vaccinated with COVID-19 vaccine
Who may be able to join
- Children aged 0-2;
- No history of blood transfusion, chemotherapy, or related immunosuppressive therapy; No immune system related diseases;
Who cannot join
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuting Yang
Chongqing, Chongqing Municipality, 400014
Yuting Yang, 18990304808, 412384223@qq.com
About this study
Official title: Children's Hospital of Chongqing Medical University
At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children; This will lay a foundation for further exploring the risk of COVID-19 infection in children and formulating immune prevention strategies.
- Being tested
- sars-cov-2 vaccine or infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sars-cov-2 vaccine or infectionBiological
Whether to vaccinate COVID-19 vaccine, or infect with sars-cov-2
| Study group | Role | What they receive |
|---|---|---|
| Control group 1 | Mother not vaccinated with COVID-19 vaccine Receives: Biological: sars-cov-2 vaccine or infection | |
| Control group 2 | The mother was vaccinated with COVID-19 vaccine before pregnancy, and was not infected during pregnancy Receives: Biological: sars-cov-2 vaccine or infection | |
| Control group 3 | The mother was vaccinated with COVID-19 vaccine before pregnancy, and was infected during pregnancy Receives: Biological: sars-cov-2 vaccine or infection | |
| Experimental group | The mother was not vaccinated with COVID-19 vaccine before pregnancy, so she was infected during pregnancy Receives: Biological: sars-cov-2 vaccine or infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 IgG
ELISA detection of SARS-CoV-2 IgG antibody levels
Measured: duration of time over which each participant could be 6-month to 12-month
SARS-CoV-2 neutralizing antibody
detection the level of SARS-CoV-2 neutralizing antibody
Measured: duration of time over which each participant could be 6-month to 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Sep 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Passive Transmission of Maternal and Infant AntibodiesStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yuting yang, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851911
- Sponsor's protocol ID
- 2022-380
- Status last verified
- Jul 2023
- First submitted
- 9 May 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contact the project leader
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children's Hospital of Chongqing Medical University
- ClinicalTrials.gov ID
- NCT05851911
- Acronym / sponsor ID
- 2022-380
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Children's Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 May 2023 (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.
At present, there is no relevant research focusing on children's acquisition of novel coronavirus antibodies through maternal passive transmission. Therefore, this study assessed the changes of maternal passive transmission of COVID-19 antibodies by monitoring the specific antibodies of COVID-19 in young children; This will lay a foundation for further exploring the risk of COVID-19 infection in children and formulating immune prevention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group 1 | – | Biological: sars-cov-2 vaccine or infectionMother not vaccinated with COVID-19 vaccine |
| Control group 2 | – | Biological: sars-cov-2 vaccine or infectionThe mother was vaccinated with COVID-19 vaccine before pregnancy, and was not infected during pregnancy |
| Control group 3 | – | Biological: sars-cov-2 vaccine or infectionThe mother was vaccinated with COVID-19 vaccine before pregnancy, and was infected during pregnancy |
| Experimental group | – | Biological: sars-cov-2 vaccine or infectionThe mother was not vaccinated with COVID-19 vaccine before pregnancy, so she was infected during pregnancy |
Who may qualify
- Ages
- 0 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Samples of infants not infected with COVID-19 and not vaccinated with COVID-19 vaccine
Key inclusion criteria (2 listed)
- Children aged 0-2;
- No history of blood transfusion, chemotherapy, or related immunosuppressive therapy; No immune system related diseases;
Key exclusion criteria (1 listed)
- Not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sars-cov-2 vaccine or infectionWhether to vaccinate COVID-19 vaccine, or infect with sars-cov-2 | Biological | Control group 1, Control group 2, Control group 3, Experimental group |
Primary outcome
SARS-CoV-2 IgG
Time frame: duration of time over which each participant could be 6-month to 12-month
ELISA detection of SARS-CoV-2 IgG antibody levels
SARS-CoV-2 neutralizing antibody
Time frame: duration of time over which each participant could be 6-month to 12-month
detection the level of SARS-CoV-2 neutralizing antibody
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Individual participant dataSharing planned: Undecided. Contact the project leader
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Passive Transmission of Maternal and Infant Antibodies, run by Children's Hospital of Chongqing Medical University at 1 site 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuting Yang, Ms (18990304808, 412384223@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 IgG (time frame: duration of time over which each participant could be 6-month to 12-month). 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 6 Jul 2023.