Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

Active, not recruitingOBSERVATIONAL
Enrollment

2,188

Participants

Timeline

Start Date

February 20, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Cervical Intraepithelial NeoplasiaCervical CancerPersistent Infection
Interventions
BIOLOGICAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.

OTHER

No intervention

No intervention was implemented.

BIOLOGICAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant.

Trial Locations (1)

Unknown

Sheyang County Center for Disease Control and Prevention, Yancheng

All Listed Sponsors
collaborator

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

collaborator

Center for Disease Control and Prevention, Sheyang County, Yancheng City, Jiangsu Province, China

UNKNOWN

lead

Xiamen University

OTHER

NCT06243666 - Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls | Biotech Hunter | Biotech Hunter