Trial reportCancer medicine2019
Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial.
Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00779766 (Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects), which is not on this map. Cited by 35 papers, 4 of them syntheses that pooled it.
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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.
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.
Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Who cites it
35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 56 citations in OpenAlex.
- Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.The Cochrane database of systematic reviews · 2025Pooled it
- Effectiveness of interventions to improve vaccine efficacy: a systematic review and meta-analysis.Systematic reviews · 2025Pooled it
- Comprehensive evaluation of prophylactic HPV vaccines: a systematic review and meta-analysis of efficacy, safety, and immunogenicity in males and females.Frontiers in immunology · 2025Pooled it
- Efficacy, immunogenicity and safety of HPV vaccination in Chinese population: A meta-analysis.Frontiers in public health · 2023Pooled it
- Efficacy, safety and immunogenicity of a recombinant human papillomavirus bivalent (types 16, 18) vaccine in healthy 18-30-year-old Chinese women: a phase III, double-blind, randomized, controlled trial.BMC infectious diseases · 2025Trial
- Long-term effect of mobile phone-based education and influencing factors of willingness to receive HPV vaccination among female freshmen in Shanxi Province, China.Human vaccines & immunotherapeutics · 2022Trial
- Inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.Emerging microbes & infections · 2021Trial
- Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial.The Lancet. Oncology · 2020Trial
- Long-term persistence of immune response to the AS04-adjuvanted HPV-16/18 vaccine in Chinese girls aged 9-17 years: Results from an 8-9-year follow-up phase III open-label study.Asia-Pacific journal of clinical oncology · 2020Trial
- Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial.Cancer medicine · 2019Trial
- Monitoring the safety of the adjuvanted human papillomavirus vaccine HPV-16/18-AS04 in association with pregnancy and potential immune-related diseases in China: A retrospective observational cohort study.Human vaccines & immunotherapeutics · 2026Observational
- Epidemiology and prevention of HPV-driven cervical cancer in urban-rural China: a population-based study of 60,280 women.Scientific reports · 2026Article
- Validation of TypeSeq2, a Next-Generation-Based Sequencing Assay for the Detection of 46 Human Papillomavirus Genotypes, at the US National Cancer Institute and Costa Rica Laboratories.The Journal of infectious diseases · 2025Article
- Ten-year evaluation of HPV vaccine influence on non-vaccine-type-related cervical infections and precancers in Chinese females: follow-up from a randomized control trial.Journal of the National Cancer Center · 2025Article
- Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China.Human vaccines & immunotherapeutics · 2024Article
- Parental willingness to pay and preference for human papillomavirus vaccine for girls aged 9-14 in subsidy scenarios in Shanghai, China.Human vaccines & immunotherapeutics · 2024Article
- Opportunities and challenges for human papillomavirus vaccination in China.Human vaccines & immunotherapeutics · 2024Review
- Acceptability of HPV vaccination for cervical cancer prevention amongst emerging adult women in rural Mysore, India: a mixed-methods study.BMC public health · 2024Article
- Willingness and hesitancy towards the governmental free human papillomavirus vaccination among parents of eligible adolescent girls in Shenzhen, Southern China.BMC women's health · 2024Article
- HPV genotypes in invasive cervical cancer: prevalence, risk attribution, and optimized vaccine strategies in western China.Frontiers in public health · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 7 institutions in 3 countries.
Funding
Abstract
backgroundCervical cancer is a major public health concern in China. We report the end-of-study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04-human papillomavirus (HPV)-16/18 vaccine in Chinese women aged 18-25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported.
methodsHealthy 18-25-year-old women (N = 6051) were randomized (1:1) to receive three doses of AS04-HPV-16/18 vaccine or Al(OH)
resultsIn initially HPV-16/18 seronegative/DNA-negative women, vaccine efficacy against HPV-16/18-associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP-E, 88.7% (95% CI: 18.5, 99.7) in the TVC-E, and 100% (95% CI: 17.9, 100) in the TVC-naïve. Cross-protective efficacy against incident infection with HPV-31, HPV-33 and HPV-45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP-E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti-HPV-16/18 antibodies; anti-HPV-16 and anti-HPV-18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group.
conclusionsThis is the first large-scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China.
trial registrationNCT00779766.
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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.