Human Papillomavirus VaccinesPhase 4NCT06345885
Immunogenicity and Safety of One Dose of HPV Vaccine
A Phase 4 study testing HPV vaccine in people with Human Papillomavirus Vaccines, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.
Trial summary
This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil Read more about this study
- Who is it for?
- Ages 9 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 17 Jan 2024
- Phase
- Phase 4
- 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 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female, aged between 9 and 14 years (including 9 and 14 years) on the day of enrollment
- Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
- Subjects and legal guardians are informed and agree, and sign the Informed Consent Form
- Female urine pregnancy test is negative
Who cannot join
- Axillary temperature>37.2 ℃
- Other investigational or unregistered products (drugs or vaccines) that have been used or planned to be used during the study period within 30 days prior to receiving the research vaccine
- Systemic use of immunosuppressants or other immunomodulatory drugs or corticosteroids for a long period of time (lasting for more than 14 days) within 6 months prior to receiving the research vaccine, but local use is allowed (such as ointments, eye drops, inhalers, or nasal sprays)
- Within 3 months prior to vaccination, immunoglobulin and/or blood preparations were used or planned to be used during the study period, but emergency use of tetanus immunoglobulin and rabies immunoglobulin is allowed after exposure
- Received inactivated vaccines within 14 days prior to enrollment in the study, or received live vaccines within 21 days prior to enrollment in the study
- Fever (axillary temperature ≥ 38.0 ℃) within 3 days prior to vaccination, or any acute illness requiring systemic antibiotics or antiviral treatment within the past 5 days
Show all 15Show fewer
- Previously received HPV vaccine
- Immunodeficiency diseases, chronic medical histories that require treatment for important organs such as primary diseases, cancer (or precancerous lesions), immune diseases (including systemic lupus erythematosus, rheumatoid arthritis, any condition leading to splenectomy or splenectomy, and other immune diseases that researchers believe may have an impact on immune response)
- Have a history of allergies, including serious adverse reactions from previous vaccination, such as allergies, urticaria, breathing difficulties, angiogenic edema, or abdominal pain
- Asthma, with unstable conditions in the past two years requiring emergency treatment, hospitalization, oral or intravenous corticosteroids
- Complicated with serious medical diseases, such as hypertension, heart disease, diabetes, hyperthyroidism, etc
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or coagulation disorders diagnosed by doctors
- Epilepsy, excluding febrile epilepsy under 2 years old and simple epilepsy that did not require treatment in the past 3 years
- Due to the inability to comply with research requirements due to psychological conditions, having a past or present mental illness that has not been well controlled within the past two years, requiring medication for mental illness, and having suicidal tendencies in the past five years
- According to the researcher's judgment, due to various medical, psychological, social, occupational factors or other conditions, it is contrary to the research plan or affects the recipient and guardian to sign informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Fujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian, 350012
About this study
Official title: Immunogenicity and Safety of One Dose of Cecolin and One Dose of Gardasil
This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil
- Conditions
- Human Papillomavirus Vaccines
- Being tested
- HPV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
Participants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Bivalent HPV Vaccine (Cecolin) Receives: Biological: HPV vaccine |
| Group B | Active comparator | Quadrivalent HPV vaccine (Gardasil) Receives: Biological: HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV seropositivity
Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.
Measured: At 1 month after first dose
Secondary outcomes (3)
Anti-HPV Seropositivity
Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.
Measured: At 2 months after first dose
HPV Antibody Titers
Geometric mean titers (GMT) of HPV16 and HPV18 types at 1 and 2 months after the first dose of vaccine administration in the subjects will be assessed.
Measured: At 1 and 2 months after first dose
Local and Systemic Reactions/Event
Soliciting local reactions/events; Soliciting systemic reactions/events; Non solicited adverse events; Serious adverse events
Measured: 7 and 30 days after each dose of vaccination; 0-7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start23 Feb 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccinesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiamen Innovax Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345885
- Sponsor's protocol ID
- PROPMHP002
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PubMed 41276263
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of One Dose of Cecolin and One Dose of Gardasil
- ClinicalTrials.gov ID
- NCT06345885
- Acronym / sponsor ID
- PROPMHP002
- Conditions
- Human Papillomavirus Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 3 Apr 2024 (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 will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HPV vaccineBivalent HPV Vaccine (Cecolin) |
| Group B | Active comparator | Biological: HPV vaccineQuadrivalent HPV vaccine (Gardasil) |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Female, aged between 9 and 14 years (including 9 and 14 years) on the day of enrollment
- Judged as healthy and eligible for vaccination by the investigators through a self- reported medical history and some physical examinations
- Subjects and legal guardians are informed and agree, and sign the Informed Consent Form
- Female urine pregnancy test is negative
Key exclusion criteria (15 listed)
- Axillary temperature>37.2 ℃
- Other investigational or unregistered products (drugs or vaccines) that have been used or planned to be used during the study period within 30 days prior to receiving the research vaccine
- Systemic use of immunosuppressants or other immunomodulatory drugs or corticosteroids for a long period of time (lasting for more than 14 days) within 6 months prior to receiving the research vaccine, but local use is allowed (such as ointments, eye drops, inhalers, or nasal sprays)
- Within 3 months prior to vaccination, immunoglobulin and/or blood preparations were used or planned to be used during the study period, but emergency use of tetanus immunoglobulin and rabies immunoglobulin is allowed after exposure
- Received inactivated vaccines within 14 days prior to enrollment in the study, or received live vaccines within 21 days prior to enrollment in the study
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 |
|---|---|---|
| HPV vaccineParticipants in the group A will be administrated with bivalent HPV vaccine Cecolin. The immunization schedule is 0, 6 months; Participants in the group B will be administrated with quadrivalent HPV vaccine Gardssil. The immunization schedule is 0, 2, 6 months | Biological | Group A, Group B |
Primary outcome
Anti-HPV seropositivity
Time frame: At 1 month after first dose
Seropositivity to HPV16 and HPV18 types of the neutralizing antibody in subjects will be assessed.
3 secondary outcomes
Anti-HPV Seropositivity
Time frame: At 2 months after first dose
HPV Antibody Titers
Time frame: At 1 and 2 months after first dose
Local and Systemic Reactions/Event
Time frame: 7 and 30 days after each dose of vaccination; 0-7 months
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 3 Apr 2024.
- Derived from this study: PubMed 41276263Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- 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?
A Phase 4 study testing HPV vaccine in people with Human Papillomavirus Vaccines, 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 4 inclusion and 15 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 3 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anti-HPV seropositivity (time frame: At 1 month after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345885, which also lists 1 linked publication.
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 3 Apr 2024.