Autoimmune DiseasesHPV-PRO-013NCT06824896
A Post-marketing Observational Database Study Monitoring the Safety of CecolinⓇ
An observational study of Autoimmune Diseases and Adverse Pregnancy Outcomes, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.
Trial summary
This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ). Read more about this study
- Who is it for?
- Ages 9 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Adverse Pregnancy Outcomes
- How many people
- 1,322,084 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2023to 30 Jun 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 9 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: * Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center; * Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.
Who may be able to join
- Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
- Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Database Study to Monitor Safety-related Endpoints After Marketing of Cecolin®
This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).
Read the detailed description
This study was initiated following the approval of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) (CecolinⓇ) in China. We undertook a retrospective-prospective real-world study to assess the incidence of new-onset autoimmune conditions (10 conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic) and adverse pregnancy conditions (e.g., premature birth, birth defects) among 9-45 yoa females during the pre- and post-marketing period of CecolinⓇ.
- Conditions
- Autoimmune Diseases, Adverse Pregnancy Outcomes
- Medical subject headings
- Autoimmune Diseases
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 |
|---|---|---|
| premarketing corhort | females aged 9-45 years during premarketing observation of CecolinⓇ | |
| postmarketing corhort | females aged 9-45 years during postmarketing observation of CecolinⓇ |
What is being measured
The primary outcome is the main question the study is designed to answer.
autoimmune conditions
incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic
Measured: through study completion, around 7.3 years
adverse pregnancy conditions
incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal
Measured: through study completion, around 7.8 years
Secondary outcomes (1)
other serious diseases
incidence of primary ovarian insufficiency, facial paralysis, complex regional pain syndrome and postural orthostatic tachycardia syndrome.
Measured: through study completion, around 7.3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start6 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Other
- Enrolment
- 1,322,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Innovax Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiamen University, Xiamen Health and Medical Big Data Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824896
- Sponsor's protocol ID
- HPV-PRO-013
- Acronym
- HPV-PRO-013
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 13 Feb 2025
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Database Study to Monitor Safety-related Endpoints After Marketing of Cecolin®
- ClinicalTrials.gov ID
- NCT06824896
- Acronym / sponsor ID
- HPV-PRO-013 / HPV-PRO-013
- Conditions
- Autoimmune Diseases, Adverse Pregnancy Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,322,084 participants (actual)
- Lead sponsor
- Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xiamen University, Xiamen Health and Medical Big Data Center
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Feb 2025 (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 study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ).
Detailed description
This study was initiated following the approval of the Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) (CecolinⓇ) in China. We undertook a retrospective-prospective real-world study to assess the incidence of new-onset autoimmune conditions (10 conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic) and adverse pregnancy conditions (e.g., premature birth, birth defects) among 9-45 yoa females during the pre- and post-marketing period of CecolinⓇ.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| premarketing corhort | – | –females aged 9-45 years during premarketing observation of CecolinⓇ |
| postmarketing corhort | – | –females aged 9-45 years during postmarketing observation of CecolinⓇ |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- * Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center; * Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.
Key inclusion criteria (2 listed)
- Females aged 9 to 45 years registered at the Xiamen Health and Medical Big Data Center;
- Having at least two records in the Xiamen Health and Medical Big Data Center with an interval of 12 months or more.
Key exclusion criteria (1 listed)
- -
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
autoimmune conditions
Time frame: through study completion, around 7.3 years
incidence of autoimmune conditions in rheumatologic/hematologic, gastroenterologic, endocrinologic, and ophthalmologic
adverse pregnancy conditions
Time frame: through study completion, around 7.8 years
incidence of the adverse pregnancy outcomes in maternal, fetal and neonatal
1 secondary outcome
other serious diseases
Time frame: through study completion, around 7.3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Autoimmune Diseases and Adverse Pregnancy Outcomes, run by Xiamen Innovax Biotech Co., Ltd 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: finished, as of the sponsor's last update on 13 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autoimmune conditions (time frame: through study completion, around 7.3 years). 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 13 Feb 2025.