Trial reportVaccine2024
Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9-14 years of age: Interim analysis from a phase 3 clinical trial.
Trial report in Vaccine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04508309 (Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries), which is not on this map. Cited by 17 papers, 1 of them a synthesis 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.
Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 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
- Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial.The Lancet. Infectious diseases · 2025Trial
- Evaluation of rotavirus, pneumococcal conjugate and human papillomavirus vaccination in four Pacific island countries: A cost-effectiveness modelling study.PLoS medicine · 2026Article
- Review
- Immune Responses to Human Papillomavirus After Infection and Vaccination.Current topics in microbiology and immunology · 2026Review
- Immunogenicity of one and two doses of Gardasil®9 in Tanzanian girls in the DoRIS Trial.NPJ vaccines · 2025Article
- Immunopersistence of one or two doses of an Escherichia coli produced bivalent HPV vaccine.NPJ vaccines · 2025Article
- Revisiting HPV vaccination post-COVID: geopolitical, sociocultural, and ethical disparities in global health.International journal for equity in health · 2025Review
- Immunogenicity comparison of anThe Lancet regional health. Western Pacific · 2025Article
- Cervical Cancer in the Era of HPV: Translating Molecular Mechanisms into Preventive Public Health Action.International journal of molecular sciences · 2025Review
- Long-term efficacy and immunopersistence of anThe Lancet regional health. Western Pacific · 2025Article
- Nano/Micro-Enabled Modification and Innovation of Conventional Adjuvants for Next-Generation Vaccines.Journal of functional biomaterials · 2025Review
- HPV and Cervical Cancer-Biology, Prevention, and Treatment Updates.Current oncology (Toronto, Ont.) · 2025Review
- A Comprehensive Evaluation of the HPV Neutralizing Antibodies in Guangzhou, China: A Comparative Study on Various HPV Vaccines.Vaccines · 2024Article
- Looking Back, Moving Forward: Challenges and Opportunities for Global Cervical Cancer Prevention and Control.Viruses · 2024Review
- Update on Effects of the Prophylactic HPV Vaccines on HPV Type Prevalence and Cervical Pathology.Viruses · 2024Review
- An experimental chimeric hepatitis E virus vaccine elicits both local and systemic immune responses.Frontiers in microbiology · 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
13 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundWorld Health Organization human papillomavirus (HPV) vaccination recommendations include a single- or two-dose schedule in individuals 9-20 years old and advice for generating data on single-dose efficacy or immunobridging. The ongoing Phase 3 trial of Innovax's bivalent (types 16 and 18) HPV vaccine (Cecolin®) assesses in low- and middle-income countries alternative dosing schedules and generates data following one dose in girls 9-14 years old. Interim data for the 6-month dosing groups are presented.
methodsIn Bangladesh and Ghana, 1,025 girls were randomized to receive either two doses of Cecolin at 6-, 12-, or 24-month intervals; one dose of Gardasil® followed by one dose of Cecolin at month 24; or two doses of Gardasil 6 months apart (referent). Serology was measured by enzyme-linked immunosorbent assay (ELISA) and, in a subset, by neutralization assays. Primary objectives include immunological non-inferiority of the Cecolin schedules to referent one month after the second dose. Safety endpoints include reactogenicity and unsolicited adverse events for 7 and 30 days post-vaccination, respectively, as well as serious adverse events throughout the study.
resultsInterim analyses included data from the two groups on a 0, 6-month schedule with 205 participants per group. One month after Dose 2, 100% of participants were seropositive by ELISA and had seroconverted for both antigens. Non-inferiority of Cecolin to Gardasil was demonstrated. Six months following one dose, over 96% of participants were seropositive by ELISA for both HPV antigens, with a trend for higher geometric mean concentration following Cecolin administration. Reactogenicity and safety were comparable between both vaccines.
conclusionsCecolin in a 0, 6-month schedule elicits robust immunogenicity. Non-inferiority to Gardasil was demonstrated one month after a 0, 6-month schedule. Immunogenicity following one dose was comparable to Gardasil up to six months. Both vaccines were safe and well tolerated (ClinicalTrials.gov No. 04508309).
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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.