Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
Condition: Poliomyelitis; Acellular Pertussis; Tetanus; Diphtheria; Hepatitis B
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix™ penta; Infanrix™ hexa
Intervention description: Subjects received a booster dose; Subjects received a booster dose
Intervention MeSH terms: PENTA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 283.0
Sex: All
Minimum age: 18 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infanrix hexa; combined vaccine

Summary:

      The new formulation administered as a 4th consecutive dose will be compared to the current
      formulation of the vaccine in this partially double blind study.

      The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study
      will be open with respect to the DTPa-HBV-IPV group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  Subjects must have completed full three-dose primary vaccination course with
             DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study
             NCT00320463).

          -  A male or female between, and including 18 and 23 months of age at the time of the
             booster vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccines
             within 30 days preceding the booster dose of study vaccine, or planned use during the
             study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the booster dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             within 30 days of the booster dose.

          -  Participation in another clinical study, between the primary study NCT00320463 and the
             present booster study, or at any time during the study, in which the subject has been
             or will be exposed to an investigational or a non-investigational product.

          -  Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and
             hepatitis B since the conclusion visit of study NCT00320463.

          -  Previous booster vaccination against Haemophilus influenzae diseases in the
             DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.

          -  History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B
             and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             physical examination.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster dose or planned administration during the study period.

          -  Any of the following adverse events having occurred after previous administration of
             DTP vaccine:

          -  Hypersensitivity reaction due to the vaccine.

          -  Encephalopathy defined as an acute, severe central nervous system disorder of unknown
             etiology occurring within 7 days following previous vaccination and generally
             consisting of major alterations in consciousness, unresponsiveness, generalized or
             focal seizures that persist more than a few hours, with failure to recover within 24
             hours.

          -  Any of the following adverse events having occurred after previous administration of
             DTP vaccine:

          -  Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.

          -  Collapse or shock-like state within 48 hours of vaccination.

          -  Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of
             vaccination.

          -  Convulsions with or without fever, occurring within 3 days of vaccination