Clinical Trials Logo

Clinical Trial Summary

Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.


Clinical Trial Description

This study is a multi-centre, randomized, blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent. After informed and received the consent of participants/guardians, 1200 healthy females aged 9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1, vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo diluent. Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6 months). After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. For every participants, blood samples will be collected before the first inoculation (month 0), one month after the final inoculation (month 7), 6 months after the final inoculation (month 12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and immunogenicity analysis. For participants in 9-14 age group who received the vaccine, neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune persistency. Meanwhile, some participants will be chosen to study the deviation of gene expression after the vaccination and the association of that with the neutralizing antibody level. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02740790
Study type Interventional
Source Shanghai Zerun Biotechnology Co.,Ltd
Contact
Status Completed
Phase Phase 2
Start date September 2013
Completion date December 2017

See also
  Status Clinical Trial Phase
Completed NCT01845779 - Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal N/A
Completed NCT02808832 - An HPV Vaccine Provider Intervention in Safety Net Clinics N/A
Completed NCT01422356 - Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men N/A
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A
Completed NCT01456715 - Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later. Phase 3
Completed NCT02968420 - Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine Phase 4
Completed NCT02007421 - Study of the Prevention of Anal Cancer N/A
Recruiting NCT04708470 - A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers Phase 1/Phase 2
Completed NCT02267876 - Longitudinal Clinical Evaluation of the HPV Assay on the BD VIPER LT System With Cervical Specimens
Recruiting NCT01459289 - Psychosocial Effect of HPV Positivity N/A
Completed NCT01358097 - Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy N/A
Completed NCT01342978 - Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time N/A
Not yet recruiting NCT06434337 - Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
Active, not recruiting NCT02576561 - Safety and Efficacy Study of TVGV-1 Vaccine to Treat HPV Induced Cervical HSIL Phase 2
Terminated NCT02503111 - The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men N/A
Recruiting NCT02126189 - The Princess Alexandra Hospital and the QIMR Berghofer Medical Research Institute Head and Neck Cancer Study N/A
Completed NCT01766284 - Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix N/A
Completed NCT01524003 - Chinese Cancer Prevention Study(CHICAPS) N/A
Recruiting NCT05026138 - Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)
Recruiting NCT03742869 - HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma