Clinical trial · Interventional
A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of HPV-16/18 Vaccine in Healthy Females Aged 18-30 Years
NCT02733068CI-TRIAL-00062749completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase III Double Blinded, Randomized Controlled Study to Evaluate Efficacy of Protection Against HPV-16 and 18 Related Diseases, Immunogenicity and Safety of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Healthy Females Aged 18-30 Years.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Human Papilloma Virus Infection Type 16 | — | UNRESOLVED | — |
| Human Papilloma Virus Infection Type 18 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV-16/18 placebo | Biological | — | UNRESOLVED |
| HPV-16/18 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HPV-16/18 vaccine
- description
- Including 6000 participants who received the HPV-16/18 vaccine 0.5ml.
- interventionNames
- Biological: HPV-16/18 vaccine
- type
- PLACEBO_COMPARATOR
- label
- HPV-16/18 placebo
- description
- Including 6000 participants who received the HPV-16/18 placebo 0.5ml.
- interventionNames
- Biological: HPV-16/18 placebo
Primary outcomes (1)
- measure
- Cervical intraepithelial neoplasia grade 2 or more (CIN 2+) caused by HPV type 16 and/or 18.
- timeFrame
- five years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * 18-30 healthy female * enable to provide an legal identification * have the ability to understand and sign the Informed Consent Form * confirmed by the investigator that the participant has the ability to comply with the protocol requirements * agreed to use effective contraceptive method in 7 months or has no plan of pregnancy * can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection Exclusion Criteria: * has received HPV vaccine previously; have received other research or unregistered product (drug or vaccine) within 30 days before the first injection * within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine * has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine * has a history of epilepsy, convulsion or has a family history of mental diseases * has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease * used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months * asplenia, functional asplenia, or splenectomize * liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor * coagulation disorders * in menstrual period or acute diseases * pregnant, or less than 8 weeks after delivery * has a history of sexual transmitted disease * had total hysterectomy or pelvic radiotherapy * has cervical abnormalities * abnormal screening results for cervical cancer or had CIN in two years * according to the judgement of investigator, participant has conditions that were not suitable for this trial * planning to move out of the clinical trial site during the research period * never has vaginal sexual activity
References
Publications (1)
- DERIVEDShi L, Gao X, Huang L, Gao Z, Li J, Yu B, Fan H, Li G, Wang Y, Li Q, Yuan L, Li C, Mo Z; HPV1003 Study group; Li Shi; Ke Li; Min Ji; Ya-Lin Hu; Ling-Yun Zhou; Xue-Mei Yan; Jing-Jing Chen; Wei Li; Zi-Long Wang; Zhen Huang; Yu-Liang Zhao; Rong-Cheng Li; Yan-Ping Li; Nian-Min Shi; Qiang Lu; Bin He; Shi-Fang Wen; Dong-Zhang Yang; Guo-Gang Liu; Yan-Xia Cai; Wei-Jiang Cui; Jiang-Bing Zheng; Zhan-Bo Geng; Yan-Hua Xie; Yong-Biao Ren; Hai-Song Zhou. 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 Infect Dis. 2025 Dec 18;26(1):248. doi: 10.1186/s12879-025-12064-1. PMID 41413453