Trial reportHuman vaccines & immunotherapeutics2014
Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese girls and women aged 9 to 45 years.
Trial report in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 16 papers, 5 of them syntheses that pooled 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.
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
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) 580299 Vaccine in Healthy Chinese Female Subjects
Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects
Who cites it
16 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Efficacy, immunogenicity and safety of HPV vaccination in Chinese population: A meta-analysis.Frontiers in public health · 2023Pooled it
- Meta-analysis of the risk of autoimmune thyroiditis, Guillain-Barré syndrome, and inflammatory bowel disease following vaccination with AS04-adjuvanted human papillomavirus 16/18 vaccine.Pharmacoepidemiology and drug safety · 2020Pooled it
- Benefits and harms of the human papillomavirus (HPV) vaccines: comparison of trial data from clinical study reports with corresponding trial register entries and journal publications.Systematic reviews · 2020Pooled it
- Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.The Cochrane database of systematic reviews · 2018Pooled it
- Comparison between the safety of the HPV vaccine versus placebo: a systematic review and meta-analysis of randomized clinical trials.Jornal de pediatriaPooled it
- 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
- Reactogenicity of Cervarix and Gardasil human papillomavirus (HPV) vaccines in a randomized single blind trial in healthy UK adolescent females.Human vaccines & immunotherapeutics · 2017Trial
- 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
- Pharmacovigilance signal detection of central nervous system demyelinating diseases following human papillomavirus vaccination: data mining and signal analysis based on the VAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Review
- 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
- The Non-inferiority of Human Papillomavirus Vaccine Immunogenicity Among Women Over 26 Years: A Systematic Review.Cureus · 2024Review
- Immunogenicity, efficacy, and safety of human papillomavirus vaccine: Data from China.Frontiers in immunology · 2023Review
- Different dose series of human papillomavirus vaccine in young females: a pair-wise meta-analysis and network meta-analysis from randomized controlled trials.Frontiers in public health · 2023Review
- Safety of Human Papillomavirus Vaccines: An Updated Review.Drug safety · 2018Review
- Safety of human papillomavirus vaccines in healthy young women: a meta-analysis of 24 controlled studies.Journal of pharmaceutical health care and sciences · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immunogenicity and safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine were evaluated in healthy Chinese females aged 9-45 years in 2 phase IIIB, randomized, controlled trials. Girls aged 9-17 years (ClinicalTrials.gov, NCT00996125) received vaccine (n = 374) or control (n = 376) and women aged 26-45 years (NCT01277042) received vaccine (n = 606) or control (n = 606) at months 0, 1, and 6. The primary objective was to show non-inferiority of anti-HPV-16 and -18 immune responses in initially seronegative subjects at month 7, compared with Chinese women aged 18-25 years enrolled in a separate phase II/III trial (NCT00779766). Secondary objectives were to describe the anti-HPV-16 and -18 immune response, reactogenicity and safety. At month 7, immune responses were non-inferior for girls (9-17 years) vs. young women (18-25 years): the upper limit of the 95% confidence interval (CI) for the geometric mean titer (GMT) ratio (women/girls) was below the limit of 2 for both anti-HPV-16 (0.37 [95% CI: 0.32, 0.43]) and anti-HPV-18 (0.42 [0.36, 0.49]). Immune responses at month 7 were also non-inferior for 26-45 year-old women vs. 18-25 year-old women: the upper limit of the 95% CI for the difference in seroconversion (18-25 minus 26-45) was below the limit of 5% for both anti-HPV-16 (0.00% [-1.53, 1.10]) and anti-HPV-18 (0.21% [-1.36, 1.68]). GMTs were 2- to 3-fold higher in girls (9-17 years) as compared with young women (18-25 years). The HPV-16/18 AS04-adjuvanted vaccine had an acceptable safety profile when administered to healthy Chinese females aged 9-45 years.
Indexed as
Identifiers
What OpenQuestion holds
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.