WHO ICTRP trial

Evaluation of immunogenicity and safety of two 2-dose Human Papillomavirus (HPV)…

EUCTR2011-000757-22-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2011-000757-22-DE
Public title Evaluation of immunogenicity and safety of two 2-dose Human Papillomavirus (HPV) vaccine schedules in 9-14 year old girls.
Scientific title A Phase IIIb open-label, randomised, multi-centre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to alternative 2-dose schedules in 9 - 14 year old healthy females compared to the…
Primary sponsor GlaxoSmithKline Biologicals
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Taiwan;Canada;Thailand;Germany;Italy
Conditions Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human…
Interventions Trade Name: Cervarix Pharmaceutical Form: Suspension for injection in pre-filled syringe Other descriptive name: HUMAN PAPILLOMAVIRUS VACCINE [TYPES 16, 18] (RECOMBINANT, ADJUVANTED, ADSORBED) Concentration unit: µg/ml…
Registration date Apr 28, 2011
Target size 1428
Secondary IDs 114700
Registry page clinicaltrialsregister.eu

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