Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Bacterial Infections and Mycoses [01] | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) | |||||
ATC code: J07AG01/ J07AG51 | |||||
Document link: | |||||
Document date: 2011-09-23 | |||||
Study number: 208108/084 | |||||
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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