safety & immunogenicity of pneumococcal vaccine 2189242a co-administered with dtpa-hbv-ipv/hib in healthy infants

Conditions: Infections, Streptococcal

Summary: this study will assess the safety, reactogenicity and immunogenicity of two formulations of gsk biologicals' pneumococcal vaccine 2189242a given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with dtpa-hbv-ipv/hib vaccine.

this study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of gsk biologicals' pneumococcal vaccine 2189242a \[high dose (hd) or low dose (ld)\] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with infanrix hexa™ and compared to the vaccination with synflorix™ and with prevnar 13™ similarly co-administered with the infanrix hexa™ vaccine.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol * male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination. * written informed consent obtained from the parents/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of 36 to 42 weeks inclusive. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * previous vaccination against s. pneumoniae since birth. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * major congenital defects or any chronic illness. * history of any neurologic disorders or seizures. * acute disease and/or fever at the time of enrolment. * fever is defined as temperature \>= 38.0°c on rectal setting or \>= 37.5°c on oral or axillary setting. * subjects with a minor illness without fever may be enrolled at the discretion of the investigator. * administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.

Keywords: haemophilus influenzae streptococcus pneumoniae immunogenicity pneumococcal vaccine infants safety