A Phase 4 interventional study of Cecolin and Hecolin in Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18 and Hepatitis E Virus Infection, sponsored by Xiamen Innovax Biotech Co., Ltd. Status unknown at 1 site in China. Open to female participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-13.
Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
Cecolin is the first Chinese domestic human papillomavirus (HPV) vaccine. Cecolin is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Hecolin is the first prophylactic vaccine against hepatitis E virus (HEV). The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with Cecolin and Hecolin.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's planned enrollment of 480 is above the median of 330 across 26 interventional studies indexed under Hepatitis E.
Browse Hepatitis E studies →Xiamen Innovax Biotech Co., Ltd is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will be simultaneously administrated with HPV and HEV vaccine. The immunization schedule is 0,1,6 months.
Biological: Cecolin · Biological: Hecolin
Participants in this arm will be administrated with HPV vaccine. The immunization schedule is 0,1,6 months.
Biological: Cecolin
Participants in this arm will be administrated with HEV vaccine. The immunization schedule is 0,1,6 months.
Biological: Hecolin
Bivalent HPV Vaccine
Hepatitis E vaccine
evaluate the concentration of IgG antibodies to HPV-16
Detect the level of IgG antibodies to HPV-16 at 7 month to determine whether group A is non-inferior to group B
Time frame: At 7 months after first dose
evaluate the concentration of IgG antibodies to HPV-18
Detect the level of IgG antibodies to HPV-18 at 7 month to determine whether group A is non-inferior to group B
Time frame: At 7 months after first dose
evaluate the concentration of IgG antibodies to HEV
detect the level of IgG antibodies to HEV at 7 month to determine whether group A is non-inferior to group C
Time frame: At 7 months after first dose
Local and systematic adverse events/reactions occurred within 7 days after each vaccination
Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: During the 7-day period following each vaccination
Adverse events/reactions occurred within 30 days after each vaccination
To evaluate number of adverse events/reactions compared with non-simultane vaccination group.
Time frame: Within 30 days after any vaccination
Serious adverse events occurred throughout the study
Safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group
Time frame: Up to 7 months
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hecolin
Xiamen Innovax Biotech Co., Ltd