Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Condition: Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Tetanus; Diphtheria; Poliomyelitis; Tetany
Intervention: Infanrix-IPV+Hib™
Intervention description: Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 321.0
Sex: All
Minimum age: 12 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: booster; Infanrix-IPV+HibTM; DTPa-IPV/Hib; Vietnamese toddlers

Summary:

      This study aims to evaluate the safety and reactogenicity of a booster dose of
      Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age
      who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within
      their first six months of lives.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.

          -  A male or female between, and including, 12 and 24 months of age at the time of
             vaccination.

          -  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.

          -  Subjects who were primed with three doses of a DTP and polio vaccine in the first 6
             months of life, and who have received the last dose of the primary vaccination at
             least six months before the receipt of study vaccine.

        Exclusion Criteria:

          -  Child in care.

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the dose of study vaccine, or planned use during the study
             period.

          -  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.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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 or intercurrent booster vaccination against diphtheria, tetanus,
             pertussis, poliomyelitis and/or Hib disease or vaccination.

          -  History of any neurological disorders or seizures.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  Acute disease and/or fever at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding vaccination or planned administration during the study period.