Clinical trial · Observational
The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female
The Durability of Protection Study of A Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Women Aged 18 to 45 Years
NCT04969445CI-TRIAL-00063429unknownClinicalTrials.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)
The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.
Conditions
Conditions (5)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Persistent Infection | — | UNRESOLVED | — |
| Vaginal Intraepithelial Neoplasia | Vaginal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Vaccine group
- description
- Participants in this arm have received 3 doses of HPV 16/18 bivalent vaccine that contains 40μg HPV 16 virus-like particle antigen and 20μg HPV 18 virus-like particle antigen adsorbed in alum-adjuvant.
- interventionNames
- Biological: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)
- label
- Control group
- description
- Participants in this arm have received 3 doses of HEV vaccine that contains 30μg HEV virus-like particle antigen adsorbed in alum-adjuvant.
Primary outcomes (2)
- measure
- Number of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
- timeFrame
- expected 2-3 years
- description
- To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 54 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants who participated in the Phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006) and received at least one dose; 2. Participants can fully understand the study content and sign an informed consent form； 3. Able to comply with the requests of the study; Exclusion Criteria: 1. Participants used other HPV vaccine products (including both marketed and unmarketed vaccines) since participating in the Phase III clinical study. 2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
References
Publications (0)
Data not yet available
No reference posted for this study.