Trial intelligence / Profile preview

Synflorix co-administered with Pediacel versus Infanrix hexa in infant primary and booster vaccination

2007-004002-26Phase 3Completed

Sponsor
GSK
Start
Oct 2007
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 3, randomised, single-blind trial in pneumococcal disease, Haemophilus influenzae type b disease (Hib), diphtheria and 4 more comparing Synflorix + Pediacel, Synflorix + Infanrix hexa and Prevenar + Pediacel (3 arms). Primary endpoints: Primary immunogenicity endpoint after primary vaccination and Non-inferiority of Pediacel co-administered with 10Pn-PD-DiT versus Prevenar co-administration. Started Oct 2007; status: completed.

02

Drugs

10-valent pneumococcal conjugate vaccinediphtheria toxoid + tetanus toxoid + acellular pertussis vaccine + inactivated poliovirus vaccine + haemophilus influenzae type b conjugate vaccinepertussis filamentous haemagglutinin
03

Conditions

pneumococcal diseaseHaemophilus influenzae type b disease (Hib)diphtheriaTetanuspertussis

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