Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Condition: Poliomyelitis; Tetanus; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Intervention: Infanrix hexa™
Intervention description: Intramuscular, three doses
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infanrix hexa™; Primary vaccination; India; combination vaccine; infants

Summary:

      This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when
      administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks
      or a 2-4-6 months schedule.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  A male or female between, and including, 6 and 10 weeks of age at the time of the
             first vaccination

          -  Documented administration of a hepatitis B vaccine dose at birth

          -  Subjects who the investigator believes that their parent(s)/legally acceptable
             representative(s) [LAR(s)] can and will comply with the requirements of the protocol

          -  Written informed consent obtained from the parent(s)/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 at least 36 weeks

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANYexclusion
        criterion applies, the subject must not be included in the study:

          -  Child in care

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the first dose, or planned use during the study period

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose

          -  Administration of a vaccine not foreseen by the study protocol, within 30 days prior
             to the first study visit, or planned administration during the study period, with the
             exception of oral human rotavirus (HRV) vaccination which is allowed at any time
             during the study

          -  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

          -  Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
             Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a
             birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local
             standard of care

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Family history of congenital or hereditary immunodeficiency

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine

          -  Major congenital defects or serious chronic illness

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period

          -  Acute disease and/or fever at the time of enrolment