Evidence map›Paper›PMID 35358015›Full record

Trial reportHuman vaccines & immunotherapeutics2022

The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age.

Chao Zhao, Yun Zhao, Jingran Li, Mingzhu Li, Yanyan Su, Xin Mi, Su Yi La Tu, Danhua Shen, Lihua Ren, Yanyan Li and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00834106 (A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV), which is not on this map. Cited by 17 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 5 pooled it
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00834106 phase3completednot on this map

A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2016Enrolled3,006ConditionsHPV InfectionsArmsQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: placebo (unspecified)
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 5 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Prophylactic HPV vaccination in HPV-related gynecologic cancers: European Society of Gynecological Oncology (ESGO) prevention committee opinion.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Guideline
  4. Pooled it
  5. Pooled it
  6. Article
  7. Review
  8. Article
  9. Review
  10. Immune Responses to Human Papillomavirus After Infection and Vaccination.Current topics in microbiology and immunology · 2026
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Chao ZhaoDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Yun ZhaoDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Jingran LiDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Mingzhu LiDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Yanyan SuDepartment of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.
Xin MiDepartment of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.
Su Yi La TuDepartment of Obstetrics and Gynecology, Xilinguolemeng Xianghuangqi Maternity and Child Health Hospital, Inner Mongolia Autonomous Region, China.
Danhua ShenDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Lihua RenDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Yanyan LiDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
Linhong WangNational Center for Women and Children's Health, Chinese Center for Disease Control and Prevention, Beijing, China.
Lihui WeiDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.ORCID 0000-0003-1388-6691
Peking University · CNShunyi Hospital of Beijing Traditional Chinese Medicine Hospital · CNInner Mongolia Maternal and Child Health · CNNational Center for Women and Children’s Health, China CDC · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the base study were selected and invited for this long-term follow-up (LTFU) study to assess the long-term effectiveness of the 4vHPV vaccine in preventing HPV-related diseases. A total of 368 participants were included in this LTFU study with a median follow-up of 94 months. Among 27 participants (Vaccine vs. Placebo: 8 vs. 19) who underwent colposcopy and biopsy due to cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) was observed in the vaccine group while two HPV-16-related cases (CIN1/VaIN) were observed in the placebo group. There were another two HPV-related cases (non-vaccine HPV types) found in the placebo group. Consistent with the findings from global studies that suggested long-term efficacy of 4vHPV vaccine, our study showed continued protective effect of 4vHPV vaccine against HPV-related precancerous diseases through a median follow-up time of 94 months with the longest follow-up time of 125 months after completing three doses of vaccination among Chinese women 20-45 years of age.

Indexed as

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus InfectionsUterine Cervical DysplasiaAdultChinaDouble-Blind MethodFemaleFollow-Up StudiesHuman papillomavirus 16Human papillomavirus 18HumansImmunization ScheduleMiddle AgedPapillomaviridaeVaccine EfficacyYoung AdultHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18effectivenessHuman papillomavirus vaccinelong-term follow-up

Identifiers

PMID35358015
PMCPMC9225595
OpenAlexW4220919625

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.