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Study to evaluate the immunogenicity and safety of GSK Biologicals’ thimerosal-free TIV Flu vaccine versus a licensed comparator in children

Mise à jour : Il y a 4 ans
Référence : EUCTR2015-001258-13

Femme et Homme

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Extrait

•To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.5mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination. •To demonstrate the immunological non-inferiority (in terms of GMTs and seroconversion rates) of TF Fluarix (0.25mL) versus Fluzone (0.25mL) in subjects (6 to 35 months) at approximately 28 days (for primed subjects) or 56 days (for unprimed subjects) following initial IM vaccination

Critère d'inclusion

  • Healthy volunteers (immunisation against influenza in male and female subjects 6 to 35 months of age inclusive)

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