An observational study in Cervical Intraepithelial Neoplasia, Cervical Cancer and Vaginal Intraepithelial Neoplasia, sponsored by Jun Zhang. Completed at 1 site in China. Open to female participants aged 10 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Jun Zhang · Observational
The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).
This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.
409 studies on the registry are indexed under Uterine Cervical Dysplasia; 76 are open to participants now.
This study's enrollment of 940 is above the median of 435 across 110 observational studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Jun Zhang is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants who participated in the bridging study (Unique Protocol ID:HPV-PRO-006-2, Identifiers: NCT02562508) and received at least one dose will be recruited.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
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 have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
Procedure: 2 doses of HPV 16/18 bivalent vaccine
Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific IgG antibody)
To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1
Time frame: Month 18 and 30
Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody)
To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on 18 and 30 months after the dose 1
Time frame: Month 18 and 30
All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded
Time frame: between 7 months and 30months after the dose1
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Jun Zhang