Extrait

•To describe the safety of 1 dose of FLU D-QIV vaccine produced by the IP and 1 dose of FLU D-QIV vaccine produced by the LP in terms of solicited (7 days after vaccination) and unsolicited adverse events (AEs) 21 days after vaccination in subjects aged 18-49 years. •To demonstrate the immunogenic non-inferiority of FLU D-QIV IP as compared to FLU D-QIV LP in terms of haemagglutination inhibition (HI) geometric mean titer (GMT) ratio at 28 days after completion of the vaccination series in subjects aged 3-17 years. •To demonstrate the immunogenic non-inferiority of FLU D-QIV IP as compared to FLU D-QIV LP in terms of HI GMT ratio at 28 days after completion of the vaccination series in subjects aged 6-35 months. •To demonstrate there is no significant increase of fever ≥38ºC after any dose with FLU D-QIV IP compared to FLU D-QIV LP during the 7 days post-vaccination in subjects aged 6-35 months.

Critère d'inclusion

• Healthy volunteers (Active immunization of adults and children against influenza)

Liens

• euctr
• ictrp
• euctr
• ictrp
• euctr
• ictrp