Clinical trial: Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine (NCT00880477)

Eligibility criteria:
Inclusion Criteria:

        Inclusion criteria for enrolment at birth

          -  Written informed consent obtained from the parents or guardians of the subject.

          -  A male or female infant born after a normal gestation period (between 36 and 42
             weeks).

          -  Born to a mother seronegative for HBsAg.

          -  Free of obvious health problems as established by clinical examination before entering
             into the study.

        Inclusion criteria for administration of the combined vaccine regimen

          -  Between, and including, 6 and 8 weeks of age at the time of the first dose of the
             three-dose course of vaccination.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into this phase of the study.

        Inclusion criteria for administration of the booster dose

          -  Between, and including, 15 and 18 months of age at the time of the booster
             vaccination.

          -  Written informed consent obtained from the parents or guardians of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Completion of the three-dose primary vaccination course.

        Exclusion Criteria:

        Exclusion criteria for enrolment at birth

          -  A family history of congenital or hereditary immunodeficiency.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection.

          -  Major congenital defect(s).

        Exclusion criteria for administration of the combined vaccine regimen

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration Immunosuppressants or other immune-modifying drugs since birth.

          -  Any chronic drug therapy to be continued during the study period.

          -  Planned administration/ administration of a vaccine except Bacille Calmette-Guérin
             vaccine during the period starting from 30 days before each dose of vaccines and
             ending 30 days after.

          -  Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae
             type b disease.

          -  History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or
             Haemophilus influenzae type b disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

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

        Exclusion criteria for administration of the booster dose

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccines within 30 days preceding the booster dose of study vaccines, or planned use
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months of vaccination.

          -  Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B,
             polio and/or Haemophilus influenzae type b.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus infection.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Acute disease at the time of enrolment.

          -  History of any neurologic disorders or seizures.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding the booster dose of study vaccine or planned administration during the study
             period.

          -  Hypersensitivity reaction due to vaccine in primary course

          -  Encephalopathy within 7 days of previous vaccination with DTP vaccine
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Weeks old.
Subject must be at most 8 Weeks

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction