A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar
Phase of Trial: Phase II
Latest Information Update: 27 Nov 2018
At a glance
- Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hepatitis B vaccine recombinant; Hib-DTaP-poliovirus vaccine; Pneumococcal 7-valent CRM197 vaccine conjugate
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Pneumococcal infections; Poliomyelitis; Tetanus
- Focus Adverse reactions; Pharmacodynamics
- Sponsors Sanofi; sanofi pasteur
- 27 Nov 2018 Result analysis from NCT00362427 , NCT01337167 , NCT01340937, NCT01341639 , NCT01480258 , NCT01553279 , providing a comprehensive safety profile, published in the Pediatric Infectious Disease Journal.
- 01 Jan 2014 Results published in the Pediatric Infectious Disease Journal.
- 02 Mar 2010 Actual patient number chnaged from 459 to 460 as reported by ClinicalTrials.gov.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History