Infections, Streptococcal Clinical Trial
Official title:
Study to Compare Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of
the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of
Synflorix (preservative-free) in terms of immune responses to the 10 vaccine pneumococcal
serotypes (primary objective) and to the vaccine-related pneumococcal serotype 19A (first
secondary objective), after administration of a 3-dose primary vaccination course at 6, 10
and 18 weeks of age co-administered with the first 2 doses of DTPw-HBV/Hib vaccine given at
6, 10 and 14 weeks of age (according to the Expanded Program on Immunization (EPI) schedule).
In addition, the study will also assess the safety, reactogenicity, immunogenicity and
antibody persistence (approximately 7 months following primary vaccination) of the 4-dose
presentation of the 10Pn-PD-DiT vaccine given as primary vaccination schedule at 6, 10 and 18
weeks of age followed by a booster dose at 38 weeks.
This study also aims at assessing the safety, reactogenicity and immunogenicity of the 4-dose
presentation of the 10Pn-PD-DiT vaccine when given as a booster dose at approximately 9
months of age.
n/a
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