Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the 1 year immunogenicity persistence of Rabipur in children 6-17 years of age, and compare the Zagreb regimen with the Essen regimen.


Clinical Trial Description

The clinical basis for the last renewal of the Rabipur license in China was the results from study V49_24 (NCT01680016), an immunogenicity and safety trial conducted in Chinese children (6 to 17 years) and adults (≥51 years), which confirmed the non-inferior immunogenicity of the Zagreb versus the conventional Essen post exposure prophylaxis intramuscular (PEP IM) regimen at Day 15 for both age groups.

At the time of license renewal in 2015, the Chinese health authorities requested that GSK continue to conduct immunogenicity persistence follow-ups for at least 1 year to compare the Zagreb regimen with the Essen regimen in populations under 17 years old.

V49_24E1 is an extension study to meet this request, in which subjects aged 17 years or younger who were immunized in the parent trial V49_24 will be recalled for a blood immunogenicity analysis approximately 4-5 years after the original vaccination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03192371
Study type Interventional
Source GlaxoSmithKline
Contact
Status Withdrawn
Phase Phase 4
Start date February 15, 2018
Completion date May 12, 2019

See also
  Status Clinical Trial Phase
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT04644484 - A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety Phase 3
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Completed NCT00734175 - Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine Phase 1
Completed NCT00516035 - Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults Phase 1
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Recruiting NCT06113757 - Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease N/A
Completed NCT01991587 - Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults Phase 1/Phase 2
Completed NCT03294135 - The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine Phase 4
Active, not recruiting NCT02545517 - A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens Phase 3
Active, not recruiting NCT05619770 - Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects Phase 1
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Active, not recruiting NCT01055990 - Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients Phase 2
Completed NCT00980447 - Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults Phase 2
Completed NCT01842997 - Safety of H1N1 Influenza Vaccination in Pregnant Women Phase 4
Completed NCT00380237 - Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B) Phase 1
Completed NCT00219453 - Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination Phase 1
Completed NCT02548078 - A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children Phase 2