Cervical Intraepithelial NeoplasiaPhase 4NCT05426148

Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female

A Phase 4 study testing Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin® in people with Cervical Intraepithelial Neoplasia and Cervical Cancer, run by Xiamen Innovax Biotech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) . 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: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia
What is being tested?: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 540 participants
Where: 1 siteChina
Study dates: 1 May 2020to 30 Apr 2021
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

1. Aged over 9 years old to 14 years old Female at the time of the first vaccine injection;
2. Statutory guardian of the subjects able to provide legal identification or the trustee able to provide the authorization certificate;
3. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations;
4.Axillary temperature is below than 37.0 ℃;
5.Negative for urine pregnancy test.
6.The statutory guardian and trustee able to understand this study information and willing to comply with all study requirements(the statutory guardian or subject able to fill in the diary card and attend the follow-up on schedule).
7.Willing to participate in this study and sign informed consent form.

Who cannot join

Administration of HPV Vaccine before the study;
Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment(such as ointment, eyedrops, inhalants or nasal sprays);
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period;
Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study;
Had a fever (axillary temperature over 38°C) within 3 days or acute illness, or use systemic antibiotics or antiviral treatment within 5 days before vaccination;

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Participate in any other clinical trial during the study period;
Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, rheumatoid arthritis, splenectomy or functional asplenia or other disease which might affect immune response), or other chronic diseases requiring treatment;
History of allergic disease or history of serious adverse events occurring after vaccination, such as allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain;
Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
Combining another severe internal medicine disease(such as hypertension, cardiopathy,diabetes and hyperthyroidism);
Anormal coagulation function or coagulopathy diagnosed by doctor;
Epilepsy(not including febrile seizures under 2 years old, alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that have not required treatment within 3 years prior to the study) ;
Anormal psychology or mind affecting the individual ability to obey the study requirements. Psychiatric disorders, not controlled in the past two years, required medication, or suicidal tendency in the past five years;
Other medical, psychological, social or occupational factors that, according to the investigators' judgment, might affect the individual ability to obey the protocol or sign the informed consent.
History of serious allergic reaction occurring after the first HPV vaccination;
History of serious adverse events following immunization caused by the first HPV vaccination;
Subject with new discovery or occurrence that does not meet the inclusion criteria, or conform to the exclusion criteria after the first HPV vaccination;
According to the judgment of the investigator, subject has newly discovered or emerging severe internal medicine disease, anormal coagulation function or coagulopathy that is not suitable for participating after the first HPV vaccination.

Trial locations and contacts

1 site in 1 country.

China1 site

Dongtai City Center for Disease Control and Prevention Dongtai, Jiangsu
Dongtai, Jiangsu, 224200

Other trials in China

About this study

Official title: A Study to Assess the Immunogenicity Consistency of Three Consecutive Batches of Commercial-scale of Recombinant Human Papillomavirus(HPV) Bivalent Vaccine (Escherichia Coli) in Healthy Female Subjects Aged 9-14 Years

This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) .

Read the detailed description

This study is a mono-center, randomization, double-blind clinical trial in healthy Female subjects between 9 to 14. Under the premise of full informed consent, 540 subjects that meet the requirement of clinical trial in the age of 9-14 will be randomly divided into 3 groups in a ratio of 1:1:1 and injected 2 consecutive batches of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) Cecolin® separately. The main outcome measures are the immunogenicity consistency and safety surveillance after inoculation according to prescribed immunization procedure.The total number of subjects should be ≥540 and ≤570.

Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection
Being tested: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®
Keywords: Human Papillomavirus Infection, Bivalent HPV Vaccine, Immunogenicity
Medical subject headings: Uterine Cervical Dysplasia, Uterine Cervical Neoplasms, Persistent Infection, Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®Biological
Also called There is no other Intervention in this study
The bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant.

Study groups in NCT05426148
Study group	Role	What they receive
Bivalent HPV Vaccine Consistency Lot 1	Experimental	Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®
Bivalent HPV Vaccine Consistency Lot 2	Experimental	Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®
Bivalent HPV Vaccine Consistency Lot 3	Experimental	Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month. Receives: Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

What is being measured

The primary outcome is the main question the study is designed to answer.

The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose.
Measure anti-HPV16/18 IgG in serum samples at 7 month to evaluate the immunogenicity of the HPV vaccine.
Measured: 7 months

Secondary outcomes (6)

Seroconversion rate of anti-HPV16/18 IgG at one month after the 2nd dose.
Describe seroconversion rate of anti-HPV16/18 IgG one month after the last dose.
Measured: 7 months
Measure solicited local adverse reactions within 7 days after each vaccination.
Measured: 7 days
Measure solicited systematic adverse reactions within 7 days after each vaccination.
Measured: 7 days
Measure unsolicited adverse reactions within 30 days after vaccination.
Measured: 30 days
Measure serious adverse events occurred throughout the study.
Measured: up to 7 months
Measure Potential Immune Mediated Diseases occurred throughout the study.
The Potential Immune Mediated Diseases refers to a disease of immune hyperfunction or immune deficiency caused by immune regulation disorder due to insufficient transmission of certain immune mediates, such as Guillain-Barre syndrome and thrombocytopenic purpura.
Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202030 Apr 2021

First posted21 Jun 2022
Study start1 May 2020
Primary completion1 Aug 2020
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical Intraepithelial NeoplasiaStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05426148
Sponsor's protocol ID: HPV-PRO-010
Status last verified: Jun 2022
First submitted: 15 Jun 2022
Last updated: 29 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Intraepithelial Neoplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Immunogenicity Consistency of Three Consecutive Batches of Commercial-scale of Recombinant Human Papillomavirus(HPV) Bivalent Vaccine (Escherichia Coli) in Healthy Female Subjects Aged 9-14 Years
ClinicalTrials.gov ID: NCT05426148
Acronym / sponsor ID: HPV-PRO-010
Conditions: Cervical Intraepithelial Neoplasia, Cervical Cancer, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Persistent Infection
Keywords: Human Papillomavirus Infection, Bivalent HPV Vaccine, Immunogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 540 participants (actual)
Lead sponsor: Xiamen Innovax Biotech Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Jiangsu Province Centers for Disease Control and Prevention, Dongtai City Centers for Disease Control and Prevention
Study start: 1 May 2020 (actual)
Primary completion: 1 Aug 2020 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 21 Jun 2022 (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 is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) .

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Bivalent HPV Vaccine Consistency Lot 1	Experimental	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.
Bivalent HPV Vaccine Consistency Lot 2	Experimental	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.
Bivalent HPV Vaccine Consistency Lot 3	Experimental	Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

Who may qualify

Ages: 9 to 14 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

1. Aged over 9 years old to 14 years old Female at the time of the first vaccine injection;
2. Statutory guardian of the subjects able to provide legal identification or the trustee able to provide the authorization certificate;
3. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations;
4.Axillary temperature is below than 37.0 ℃;
5.Negative for urine pregnancy test.

Key exclusion criteria (19 listed)

Administration of HPV Vaccine before the study;
Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period;
Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment(such as ointment, eyedrops, inhalants or nasal sprays);
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period;
Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of 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
Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®Also: There is no other Intervention in this studyThe bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant.	Biological	Bivalent HPV Vaccine Consistency Lot 1, Bivalent HPV Vaccine Consistency Lot 2, Bivalent HPV Vaccine Consistency Lot 3

Primary outcome

The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose.
Time frame: 7 months
Measure anti-HPV16/18 IgG in serum samples at 7 month to evaluate the immunogenicity of the HPV vaccine.

6 secondary outcomes

Seroconversion rate of anti-HPV16/18 IgG at one month after the 2nd dose.
Time frame: 7 months
Measure solicited local adverse reactions within 7 days after each vaccination.
Time frame: 7 days
Measure solicited systematic adverse reactions within 7 days after each vaccination.
Time frame: 7 days
Measure unsolicited adverse reactions within 30 days after vaccination.
Time frame: 30 days
Measure serious adverse events occurred throughout the study.
Time frame: up to 7 months
Measure Potential Immune Mediated Diseases occurred throughout the study.
Time frame: up to 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 29 Jun 2022.
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.

Yuemei Hu principal investigator

Jiangsu Provincial Center for Disease Prevention and Control

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 19 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 29 Jun 2022. 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?

The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose. (time frame: 7 months). 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 NCT05426148.

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 29 Jun 2022.