Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

This protocol posting has been updated following protocol amendment 3, dated 12 April 2011.
The impacted section is: Eligibility Criteria (Exclusion criteria).

Inclusion Criteria:

- Subjects for whom the investigator believes that their parent(s)/Legally Acceptable
Representative(s) (LAR[s]) can and will comply with the requirements of the protocol
(e.g., completion of the diary card, return for follow-up visits).

- A male or female between, and including, 6 and 12 weeks of age at the time of the
first vaccination.

- Written informed consent obtained from the subject's parent/LAR.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Born after a gestation period of minimum 36 weeks.

- 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
enrollment.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs since birth.

- Planned administration of a vaccine not foreseen by the study protocol within 30 days
of the first dose of study vaccine and until 30 days after the booster dose.

- Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus,
pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of
hepatitis B vaccine.

- History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis,
pneumococcal, rotavirus, poliovirus, and hepatitis B diseases.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines, including dry natural latex rubber.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at time of enrollment. All vaccines can be administered to persons with
a minor illness.

- Administration of immunoglobulins and/or any blood products since birth or planned
administration during the study period.

- Concurrent participation in another clinical study, up to 30 days prior to study entry
or 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).

- Child in care.

- History of intussusception.

- History of uncorrected congenital malformation of the gastrointestinal tract that
would predispose the infant to intussusception.

- History of Severe Combined Immunodeficiency Disease.