As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP\~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
792
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM
Unnamed facility
Nanning, Guangxi, China
To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine
Time frame: 1 Month post-dose 3
To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Time frame: 19 months post-dose 1
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