Trial intelligence / Profile preview

Infanrix-Hexa primary and booster immune response study with randomized MenC vaccine comparison in UK infants

ISRCTN27374886Phase 4Completed

Sponsor
Health Protection Agency (UK)
Start
Jun 2013
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
01

Overview

Phase 4, randomised, open-label trial in meningococcal disease, Haemophilus influenzae type b disease (Hib), pneumococcal disease and 5 more comparing Infanrix-Hexa + PCV13 + NeisVacC, Infanrix-Hexa + PCV13 + Menjugate and Infanrix-Hexa + PCV13 + Menitorix (3 arms). Primary endpoints: Hib antibody concentrations after primary immunization, MenC-specific antibody titres after primary immunization and 1 more. Started Jun 2013; status: completed.

02

Drugs

Infanrix Hexapneumococcal 13-valent conjugate vaccineMeningococcal group C polysaccharide conjugate vaccineHib-MenC-TT
03

Conditions

meningococcal diseaseHaemophilus influenzae type b disease (Hib)pneumococcal diseasediphtheriaTetanus

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