Trial intelligence / Profile preview

Preterm infant vaccine schedule study with Prevenar13 primary series randomization

2007-007535-23Phase 4Completed

Sponsor
St George's, University of London
Start
Mar 2008
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 4, randomised, open-label trial of pneumococcal 13-valent conjugate vaccine, diphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccine, Meningococcal group C polysaccharide conjugate vaccine and Hib-MenC-TT in pneumococcal disease, Haemophilus influenzae type b disease (Hib), poliomyelitis and 4 more (3 arms), sponsored by St George's, University of London. Primary endpoint: IgG geometric mean concentrations for 13 pneumococcal serotypes one month after primary immunization. Started Mar 2008; status: completed.

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Drugs

pneumococcal 13-valent conjugate vaccinediphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccineMeningococcal group C polysaccharide conjugate vaccineHib-MenC-TT
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Conditions

pneumococcal diseaseHaemophilus influenzae type b disease (Hib)poliomyelitisdiphtheriaTetanus

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