Study title: A Phase IV, randomized, single-blind, multicenter study with four vaccination groups: three different batches PCECV India, one batch PCECV Germany to compare immunogenicity and safety of PCEC Rabies Vaccine (PCECV) manufactured in Ankleshwar/India with PCECV manufactured in Marburg/Germany.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: RABIES VACCINE FOR HUMAN USE PREPARED FROM CELL CULTURE (DIPLOID CELLS) | |||||
ATC code: J07BG01 | |||||
Document link: | |||||
Document date: 2014-10-13 | |||||
Study number: M49P1 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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