Anogenital Human Papilloma Virus InfectionNCT01427777
3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
An observational study of Anogenital Human Papilloma Virus Infection, run by Guangxi Center for Disease Control and Prevention at 1 site in China.
Trial summary
The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years. Read more about this study
- Who is it for?
- Ages 9 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anogenital Human Papilloma Virus Infection
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Jun 2012
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects who participated in V501-030 in Per-protocol population
Who may be able to join
- Healthy Chinese subject who participated in V501-030 in Per-protocol population.
- Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- Subject is willing to give consent/assent.
Who cannot join
- Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
- Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.
Read the detailed description
All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HPV Vaccine | People that receive HPV vaccine in V501-030 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startSep 2011
- Study completionJun 2012 (estimated)
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 Anogenital Human Papilloma Virus InfectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rongcheng Li, Guangxi Center for Disease Control and Prevention
- Investigators
- Rongcheng Li, MD, Principal investigator, Guangxi CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427777
- Sponsor's protocol ID
- V501-030-1
- Status last verified
- Sep 2011
- First submitted
- 1 Sep 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang T, Liu Y, Li Y, Liao Y, Shou Q, Zheng M, Liao X, Li R. Evaluation on the persistence of anti-HPV immune responses to the quadrivalent HPV vaccine in Chinese females and males: Up to 3.5 years of follow-up. Vaccine. 2018 Mar 7;36(11):1368-1374. doi: 10.1016/j.vaccine.2018.02.006. Epub 2018 Feb 7.
PubMed 29428178
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
- ClinicalTrials.gov ID
- NCT01427777
- Acronym / sponsor ID
- V501-030-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangxi Center for Disease Control and PreventionOther government
- Study start
- Sep 2011
- Study completion
- Jun 2012 (estimated)
- First posted
- 2 Sep 2011 (estimated)
- 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.
The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.
Detailed description
All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV Vaccine | – | –People that receive HPV vaccine in V501-030 |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects who participated in V501-030 in Per-protocol population
Key inclusion criteria (3 listed)
- Healthy Chinese subject who participated in V501-030 in Per-protocol population.
- Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
- Subject is willing to give consent/assent.
Key exclusion criteria (3 listed)
- Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
- Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
- Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Derived from this study: PubMed 29428178Huang T, Liu Y, Li Y, Liao Y, Shou Q, Zheng M, Liao X, Li R. Evaluation on the persistence of anti-HPV immune responses to the quadrivalent HPV vaccine in Chinese females and males: Up to 3.5 years of follow-up. Vaccine. 2018 Mar 7;36(11):1368-1374. doi: 10.1016/j.vaccine.2018.02.006. Epub 2018 Feb 7.
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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.
Rongcheng Li, MD principal investigator
Guangxi CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anogenital Human Papilloma Virus Infection, run by Guangxi Center for Disease Control and Prevention 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Sep 2011. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongcheng Li, MD (86 0771 2518986, lrch2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427777, 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 2 Sep 2011.