Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
Summary
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.
Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®
Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Diphtheria
Intervention
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC, Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC, Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
Location
Coquitlam
British Columbia
Canada
V3C 4J2
Status
Completed
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00362427
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Two-hybrid System Techniques
Screening techniques first developed in yeast to identify genes encoding interacting proteins. Variations are used to evaluate interplay between proteins and other molecules. Two-hybrid techniques refer to analysis for protein-protein interactions, one-hybrid for DNA-protein interactions, three-hybrid interactions for RNA-protein interactions or ligand-based interactions. Reverse n-hybrid techniques refer to analysis for mutations or other small molecules that dissociate known interactions.
Hybrid Vigor
The adaptive superiority of the heterozygous GENOTYPE with respect to one or more characters in comparison with the corresponding HOMOZYGOTE.
Hybridization, Genetic
The genetic process of crossbreeding between genetically dissimilar parents to produce a hybrid.
Computers, Hybrid
Computers that combine the functions of analog and digital computers. (Sippl, Computer Dictionary, 4th ed)
Clinical Trials
Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The invest...
Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study
The purpose of the study is to demonstrate that the SynergEyes SA Hybrid Contact Lens clinical performance is substantially equivalent to that of the SynergEyes A Hybrid Lens when studied:...
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary ob...
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and...
This is a follow-up of Study A3L10. Immunogenicity - To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENG...
PubMed Articles
This study compared the safety and immunogenicity of DTaP(5)-IPV-Hib vaccine (followed by monovalent hepatitis B vaccine [HBV]) and DTaP(3)-HBV-IPV/Hib vaccines, both coadministered with PCV7, as a fo...
This study compared immunogenicity and safety of DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib coadministered with PCV7 at 2, 3, and 4 months (primary series) and a fourth-dose booster at 12-18 months of age. Se...
Tetravalent meningococcal serogroups ACWY conjugate vaccines will provide an advantage to those at most risk of invasive meningococcal disease; namely young children. Co-administration of ACWY-TT with...
This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim(®), Sanofi Pasteur's AcXim family) combined vaccine and of standalon...
The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=7...
