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 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction