Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

Launched by GLAXOSMITHKLINE · Sep 15, 2008

Keywords

ClinConnect Summary

This protocol posting has been updated following Protocol amendment 1 (19-MAY-2010).

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
• • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
• • Born after a gestation period of 36 to 42 weeks inclusive.
• • Healthy subjects as established by medical history before entering into the study.
• • Written informed consent obtained from the parent or guardian of the subject.
• Exclusion Criteria:
• • Use of any investigational or non-registered product 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 from birth until first primary vaccination dose..
• • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• • 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.
• • Major congenital defects or serious chronic illness.
• • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
• • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
• • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• * The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• • Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.