study to determine the immunogenicity and safety of glaxosmithkline (gsk) biologicals; infanrix hexa at 2, 4 and 6 months of age in healthy infants

Conditions: Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Tetanus; Acellular Pertussis; Hepatitis B

Summary: the purpose of this study is to assess the immunogenicity and safety of gsk biologicals' infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with prevnar and rotarix with a booster dose of gsk biologicals' infanrix and hiberix vaccines at 15-18 months of age.


Eligibility criteria:
inclusion criteria: * subjects' parent(s)/ legally acceptable representative(s) (lars) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * a male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * born full-term (i.e. after a gestation period of 37 weeks to less than 42 completed weeks \[259 to 293 days\]). * written informed consent obtained from parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * infants who have not received a previous dose of hepatitis b vaccine or those who have received only 1 dose of hepatitis b vaccine administered at least 30 days prior to enrolment. exclusion criteria: * child in care * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. for corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. inhaled and topical steroids are allowed. * planned administration/administration of a vaccine not foreseen by the study protocol within the period starting from 30 days before the first vaccination until 30 days after dose 3 (epoch 001, primary vaccination) and from 30 days before the booster dose 4 until 30 days after booster dose 4 (epoch 002, booster vaccination), i.e. the end of the study: * inactivated influenza and hepatitis a vaccines are allowed throughout the study. * routine administration(s) of vaccines are allowed from 30 days after the last dose of primary vaccination until 30 days before the booster dose and after post-booster blood sampling. routine administration of measles-mumps-rubella vaccine, varicella, pneumococcal vaccines are allowed from 30 days after last dose of primary vaccine until 30 days before booster dose and from post-booster blood sampling, as well as according to the recommended immunization schedule in us. * 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 (pharmaceutical product or device). * history of hib, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus and hepatitis b diseases. * previous vaccination against hib, diphtheria, tetanus, pertussis, pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis b vaccine. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (including yeast). * hypersensitivity to latex. * major congenital defects or serious chronic illness. * history of any neurological disorders including seizures. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * history of intussusception or of any uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. * history of severe combined immunodeficiency disease (scid). * acute disease and/or fever at the time of enrolment. * fever is defined as temperature ≥38.0°c /100.4°f by any route. the preferred route for recording temperature in this study will be rectal for epoch 001 and axillary for epoch 002. * subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

Keywords: infants safety healthy infanrix hexa immunogenicity