Human Papillomavirus VaccinesNCT05932576
A Multicenter Cohort Study Assessing the Efficacy and Adverse Effects of HPV Vaccination in Chinese Women
An observational study of Human Papillomavirus Vaccines and Efficacy, Self, run by Fujian Maternity and Child Health Hospital at 5 sites in China.
Trial summary
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and… Read more about this study
- Who is it for?
- Ages 9 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines, Efficacy, Self, Adverse Effect
- Type of treatment
- Vaccines
- How many people
- 12,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Dec 2022to 31 Dec 2024
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women aged 9-45 years who received their last dose of HPV vaccine within 12 months
Who may be able to join
- Female, aged 9-45; Get the last dose of HPV vaccine within 12 months.
Who cannot join
- Pregnancy or lactation during HPV vaccination; Those who refuse follow-up and informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yu Zhang, 0731-88877216, cszhangyu@126.com
- Recruiting
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, 350001
Binhua Dong, +8613599071900, dbh18-jy@126.com
- Recruiting
Fujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian
Weiyi Pan, 13685031683 ext. 086
- Recruiting
Maternal and Child Health Hospital of Shenzhen Province
Shenzhen, Guangdong
Zheng Zheng, M.D, +8613500056539
- Recruiting
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei
Hongning Cai, M.D, +8615926224867, catherine-527@163.com
About this study
Official title: A Multicenter Cohort Study Assessing the Efficacy and Adverse Effects of Different HPV Vaccination in Chinese Women
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. HPV vaccines have been widely introduced worldwide to prevent cancers of the lower genital tract such as cervical, anal and vulvar cancers. For different types of HPV vaccine, divided into domestic bivalent, imported bivalent (GlaxoSmithKline), quadrivalent (Merck) and nine-valent (Merck) HPV vaccine, four vaccines all prevent HPV 16/18 high-risk type infection disease, and the four and nine-valent HPV vaccine prevention genotypes are different, and different price number of protection rates, vaccination objects and immunization procedures are slightly different. At the same time, studies have shown that women after HPV vaccine, arm redness, swelling, heat and pain have a high incidence of adverse reactions, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions risk, so we plan to design a multicenter cohort study to evaluate the effectiveness of HPV vaccine with different prices. At the same time, the adverse reaction symptoms of HPV vaccine in the female population of appropriate age were monitored.
Read the detailed description
This study was led by the Fujian Provincial Maternal and Child Health Hospital, with the following research centers: Xiangya Hospital of Central South University, Fujian Provincial Center for Disease Control and Prevention, Shenzhen Maternal and Child Health Hospital, Hubei Provincial Maternal and Child Health Hospital, Shandong Province and Shaanxi Province. Recruitment was conducted in 6 provinces in different regions of China, and 2000 subjects were recruited in each province. A total of 12,000 subjects were recruited. Each subject was evaluated within 3 to 12 months after the last dose of HPV vaccine, and adverse reaction symptoms were queried by telephone follow-up and face-to-face. Peripheral blood 1 tube (3ml) was collected to detect the concentration of comprehensive antibodies to HPV vaccine. A multicenter cohort study was conducted to evaluate the effectiveness of HPV vaccine and to monitor the symptoms of adverse reactions to HPV vaccine in the female population of appropriate age.
- Conditions
- Human Papillomavirus Vaccines, Efficacy, Self, Adverse Effect, China, Woman
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 |
|---|---|---|
| The HPV vaccine group | Women aged 9-45 years who received the last dose of HPV vaccine within the past 12 months were included, and each subject was evaluated within 3-12 months after the last dose of HPV vaccine. Adverse reaction symptoms were queried by telephone follow-up and face-to-face, and peripheral blood tube (3ml) was collected to detect the concentration of comprehensive antibody to HPV vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV vaccine neutralizing antibody detection
All participants were tested for neutralizing antibodies to the HPV vaccine
Measured: Within 3 to 12 months of each subject's last dose of HPV vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binhua Dong, Fujian Maternity and Child Health Hospital
- Investigators
- Sun Pengming, PhD, Study chair, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932576
- Sponsor's protocol ID
- HVAC2302
- Status last verified
- Jun 2023
- First submitted
- 28 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Cohort Study Assessing the Efficacy and Adverse Effects of Different HPV Vaccination in Chinese Women
- ClinicalTrials.gov ID
- NCT05932576
- Acronym / sponsor ID
- HVAC2302
- Conditions
- Human Papillomavirus Vaccines, Efficacy, Self, Adverse Effect, China, Woman
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Fujian Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (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.
Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. HPV vaccines have been widely introduced worldwide to prevent cancers of the lower genital tract such as cervical, anal and vulvar cancers. For different types of HPV vaccine, divided into domestic bivalent, imported bivalent (GlaxoSmithKline), quadrivalent (Merck) and nine-valent (Merck) HPV vaccine, four vaccines all prevent HPV 16/18 high-risk type infection disease, and the four and nine-valent HPV vaccine prevention genotypes are different, and different price number of protection rates, vaccination objects and immunization procedures are slightly different. At the same time, studies have shown that women after HPV vaccine, arm redness, swelling, heat and pain have a high incidence of adverse reactions, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions risk, so we plan to design a multicenter cohort study to evaluate the effectiveness of HPV vaccine with different prices. At the same time, the adverse reaction symptoms of HPV vaccine in the female population of appropriate age were monitored.
Detailed description
This study was led by the Fujian Provincial Maternal and Child Health Hospital, with the following research centers: Xiangya Hospital of Central South University, Fujian Provincial Center for Disease Control and Prevention, Shenzhen Maternal and Child Health Hospital, Hubei Provincial Maternal and Child Health Hospital, Shandong Province and Shaanxi Province. Recruitment was conducted in 6 provinces in different regions of China, and 2000 subjects were recruited in each province. A total of 12,000 subjects were recruited. Each subject was evaluated within 3 to 12 months after the last dose of HPV vaccine, and adverse reaction symptoms were queried by telephone follow-up and face-to-face. Peripheral blood 1 tube (3ml) was collected to detect the concentration of comprehensive antibodies to HPV vaccine. A multicenter cohort study was conducted to evaluate the effectiveness of HPV vaccine and to monitor the symptoms of adverse reactions to HPV vaccine in the female population of appropriate age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The HPV vaccine group | – | –Women aged 9-45 years who received the last dose of HPV vaccine within the past 12 months were included, and each subject was evaluated within 3-12 months after the last dose of HPV vaccine. Adverse reaction symptoms were queried by telephone follow-up and face-to-face, and peripheral blood tube (3ml) was collected to detect the concentration of comprehensive antibody to HPV vaccine. |
Who may qualify
- Ages
- 9 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women aged 9-45 years who received their last dose of HPV vaccine within 12 months
Key inclusion criteria (1 listed)
- Female, aged 9-45; Get the last dose of HPV vaccine within 12 months.
Key exclusion criteria (1 listed)
- Pregnancy or lactation during HPV vaccination; Those who refuse follow-up and informed consent.
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
HPV vaccine neutralizing antibody detection
Time frame: Within 3 to 12 months of each subject's last dose of HPV vaccine
All participants were tested for neutralizing antibodies to the HPV vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
Sun Pengming, PhD study chair
Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccines and Efficacy, Self, run by Fujian Maternity and Child Health Hospital at 5 sites 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 1 inclusion and 1 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 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Dong Binhua (13599071900, dbh18-jy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccine neutralizing antibody detection (time frame: Within 3 to 12 months of each subject's last dose of HPV vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2023; AzTrials last refreshed its copy on 29 Oct 2026.