ClinicalTrials.gg
CompletedNCT05426148Updated Jun 29, 2022

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

A Phase 4 interventional study of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin® in Cervical Intraepithelial Neoplasia, Cervical Cancer and Vaginal Intraepithelial Neoplasia, sponsored by Xiamen Innovax Biotech Co., Ltd. Completed at 1 site in China. Open to female participants aged 9 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-29.

Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled May 2020, registered Jun 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
540
Allocation
Randomized
Ages
9 Years to 14 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Vaginal Intraepithelial Neoplasia
  • Vulvar Intraepithelial Neoplasia
  • Persistent Infection

Keywords

  • Human Papillomavirus Infection
  • Bivalent HPV Vaccine
  • Immunogenicity
03

In context

Uterine Cervical Dysplasia

409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.

This study's enrollment of 540 is above the median of 167 across 285 interventional studies indexed under Uterine Cervical Dysplasia.

Browse Uterine Cervical Dysplasia studies →

Lead sponsor

Xiamen Innovax Biotech Co., Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

    1. Aged over 9 years old to 14 years old Female at the time of the first vaccine injection;
    1. Statutory guardian of the subjects able to provide legal identification or the trustee able to provide the authorization certificate;
    1. 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 form.

Exclusion Criteria:

Exclusion criteria for the first vaccination:

  1. Administration of HPV Vaccine before the study;
  2. Use of any 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;
  3. Received , immunoregulation therapy or systemic therapy for more than 14 days in the 6 months before entry, except local treatment(such as ointment, eyedrops, inhalants or nasal sprays);
  4. 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;
  5. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated within 21 days preceding the first dose of the study;
  6. 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;
  7. Participate in any other clinical trial during the study period;
  8. Immunodeficiency (such as 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;
  9. History of allergic disease or history of serious adverse events occurring after vaccination, such as allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain;
  10. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
  11. Combining another severe internal medicine disease(such as hypertension, cardiopathy,diabetes and hyperthyroidism);
  12. Anormal coagulation function or coagulopathy diagnosed by doctor;
  13. 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) ;
  14. 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;
  15. 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.

Exclusion criteria for second vaccination:

  1. History of serious allergic reaction occurring after the first HPV vaccination;
  2. History of serious adverse events following immunization caused by the first HPV vaccination;
  3. Subject with new discovery or occurrence that does not meet the inclusion criteria, or conform to the exclusion criteria after the first HPV vaccination;
  4. 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.
Terms in these criteria, in plain language(6)

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.

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.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
540 participants (actual)

Study arms

  • Experimental
    Bivalent HPV Vaccine Consistency Lot 1

    Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

    Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

  • Experimental
    Bivalent HPV Vaccine Consistency Lot 2

    Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

    Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

  • Experimental
    Bivalent HPV Vaccine Consistency Lot 3

    Biological/Vaccine: Participants would receive 2 doses of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) intramuscularly at 0, 6 month.

    Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

Interventions

  • BiologicalRecombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

    Drug page: Escherichia coli

    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.

    Also known as: There is no other Intervention in this study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 months

Secondary outcomes

  1. 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.

    Time frame: 7 months

  2. Measure solicited local adverse reactions within 7 days after each vaccination.

    Time frame: 7 days

  3. Measure solicited systematic adverse reactions within 7 days after each vaccination.

    Time frame: 7 days

  4. Measure unsolicited adverse reactions within 30 days after vaccination.

    Time frame: 30 days

  5. Measure serious adverse events occurred throughout the study.

    Time frame: up to 7 months

  6. 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.

    Time frame: up to 7 months

07

Study locations

1 site
  • Dongtai City Center for Disease Control and Prevention Dongtai, Jiangsu
    Dongtai, Jiangsu 224200, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2020 to primary completion in Aug 2020, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2022
First posted
Jun 21, 2022
StartActual
May 1, 2020
Primary completionActual
Aug 1, 2020
CompletionActual
Apr 30, 2021
Last update
Jun 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05426148
Lead sponsor
Xiamen Innovax Biotech Co., Ltd
Collaborators
Jiangsu Province Centers for Disease Control and Prevention, Dongtai City Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Jun 21, 2022
Start date
May 1, 2020
Primary completion
Aug 1, 2020
Completion
Apr 30, 2021
Last update
Jun 29, 2022

Study contacts

Yuemei Hu
principal investigator · Jiangsu Provincial Center for Disease Prevention and Control

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Escherichia coli

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