Please select the eligibility criteria that correspond to the clinical trial below.
Title: Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
Brief Summary: This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy.

In this study, MMRV vaccine will also be co-administered to all children.


Options:
A: Inclusion Criteria:

1. Healthy subject of either gender,
2. Age 12 to 18 months ,
3. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
3. Any recent (≤30 days) exposure to measles, mumps or rubella,
4. Any recent (≤30 days) exposure to varicella or zoster involving:
5. Any recent (≤3 days) history of febrile illness
6. Any severe chronic disease,
7. Active untreated tuberculosis,
8. Known personal history of seizures,
9. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
10. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
12. Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
13. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
14. Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2
B: Inclusion Criteria:

* Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
* A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
* Written informed consent obtained from the parents or guardian of the subject,
* Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
* Parents/guardian of the subject must have a telephone or be able to be contacted by telephone

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).
* Previous vaccination against hepatitis A,
* History of hepatitis A,
* Known exposure to hepatitis A,
* Previous vaccination against measles, mumps, rubella and/or varicella,
* History of measles, mumps, rubella and/or varicella,
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,
* Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
* A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
* History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,
* History of anaphylactic or anaphylactoid reactions to egg proteins,
* History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.
* Major congenital defects or serious chronic illness,
* Active untreated tuberculosis,
* History of significant blood dyscrasias
* History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject)
* Acute disease at the time of vaccination
* Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period
C: Inclusion Criteria:

* Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
* A male or female child between 4 and 6 years of age, inclusive.
* 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.
* Having received 4 doses of (Diphtheria, Tetanus Acellular Pertussis) DTaP vaccine using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix and/or (inactivated poliovirus vaccine, Aventis Pasteur) IPOL in the first 2 years of life.
* Previously received 1 dose of M-M-RII and Varivax (separate or combined) in the second year of life.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
* 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 non-investigational product or device.
* History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or varicella disease, or of vaccination against these diseases given after the second year of life.
* Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
* Poliovirus vaccination with one or more doses of (oral polio virus) OPV vaccine.
* Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
* Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
* Administration of immunoglobulins and/or any blood products at any time prior to study vaccination or planned administration during the study period ending at Day 30.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
* History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
* Encephalopathy within 7 days of administration of previous dose of Infanrix or Pediarix.
* Fever \>=40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix or Pediarix not due to another identifiable cause.
* Collapse or shock-like state within 48 hours of previous dose of DTaP or DTaP-containing vaccine.
* Persistent, severe, inconsolable screaming or crying lasting ³3 hours occurring within 48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.
* Thrombocytopenia following a previous dose of M-M-RII or its component vaccines
* Inability to contact a parent/guardian of the subject by telephone.
* Blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject has been demonstrated.
* Residence in the same household as the following persons:
* New-born infants (0-4 weeks of age).
* Pregnant mother/women without documented positive history of chickenpox disease or laboratory evidence of prior varicella vaccination.
* Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
* Persons with known immunodeficiency.
* Active untreated tuberculosis.
D: Inclusion Criteria:

* A male or female child of 5 and 6 years of age at the time of vaccination.
* Subjects who received a complete 3-dose vaccination with a DTPa-based combined vaccine according to a 3-5-11 month schedule in line with recommendations in Italy.
* Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine in the second year of life, in line with recommendations in Italy.
* 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.
* 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 vaccine(s) within 30 days preceding the first 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 vaccine dose.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
* 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.
* Previous booster vaccination against tetanus, diphtheria, pertussis and/or poliomyelitis since vaccination in the first two years of life.
* Previous measles, mumps, rubella and/or varicella second dose vaccination.
* Known history of diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps, rubella and/or varicella disease.
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Administration of immunoglobulin and/or any blood products within the three months preceding vaccination or planned administration during the study period.
* Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
* Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:

  * Hypersensitivity reaction to any component of the vaccine;
  * Encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine;
  * Fever \>= 40°C within 48 hours of vaccination, not due to another identifiable cause;
  * Collapse or shock-like state within 48 hours of vaccination;
  * Convulsions with or without fever, occurring within 3 days of vaccination.
* Residence in the same household as a person high risk for varicella
* The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

  * Current febrile illness or axillary temperature ≥ 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Answer: D