Please select the eligibility criteria that correspond to the clinical trial below.
Title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
Brief Summary: The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.


Options:
A: Inclusion Criteria:

* Healthy infants as established by medical history and clinical examination before entering the study.
* Age: 6-8 weeks at the time of enrollment.
* Parental ability and willingness to provide informed consent.
* Parent who intends to remain in the area with the child during the study period.

Exclusion Criteria:

* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
* Presence of fever on the day of enrollment (temporary exclusion).
* Acute disease at the time of enrollment (temporary exclusion)
* Concurrent participation in another clinical trial throughout the entire timeframe for this study.
* Presence of significant malnutrition (weight-for-height z-score \<-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination.
* Household contact with an immunosuppressed individual or pregnant woman.
* Prior receipt of rotavirus vaccine.
* A known sensitivity or allergy to any components of the study vaccine.
* Major congenital or genetic defect.
* History of persistent diarrhea (defined as diarrhea more than 14 days).
* Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
* History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
* History of any neurologic disorders or seizures.
* Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
B: Inclusion Criteria:

* At dose 1

  1. A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
  2. Full term gestation (\>=37 weeks).
  3. Birth weight of the subject should be \>=2.5 kg.
  4. Healthy subjects as established by medical history and clinical examination before entering into the study.
  5. Did not use any dose of Rota virus vaccine.
  6. Written informed consent obtained from the parent or guardian of the subject.
* At dose 2

  1. Received dose 1.
  2. Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.
* At dose 3

  1. Received both dose 1 and dose 2.
  2. Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

Exclusion Criteria:

* At dose 1

  1. Has a chronic disease (cardiovascular, liver, kidney disease).
  2. Acute disease at the time of enrolment.
  3. Administering corticosteroids (\> 1mg/kg/day).
  4. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
  5. Immunosuppressive or immunodeficient condition.
  6. Family has immunosuppressive or immunodeficient condition medical history.
  7. History of high fever convulsion.
  8. Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
  9. Preterm of gestation delivery (gestation period \< 37 weeks).
  10. Low birth weight (\<2.5 kg).
  11. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
  12. Malnutrition.
  13. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
  14. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* At dose 2

  1. Acute disease at the time of 2nd dose.
  2. Administering corticosteroids (\> 1mg/kg/day).
  3. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
  4. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
  5. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
  6. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
  7. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
* At dose 3

  1. Acute disease at the time of 3rd dose.
  2. Administering corticosteroids (\> 1mg/kg/day).
  3. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for \>2 weeks).
  4. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
  5. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
  6. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
  7. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
C: Inclusion Criteria:

* Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.

Exclusion Criteria:

* Allergic reaction to vaccine components;
* clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
* immunocompromised.
D: Inclusion Criteria:

* Subjects with a live twin living in the same household who is also enrolled in this study.
* Born after a gestation period of ≥32 weeks,
* Discharged from hospital neonatal care stay,
* 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.
* A male or female between, and including, 6 and 14 weeks of age at the time of the first study vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Written informed consent obtained from the parent or guardian of the subjects.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Any clinically significant history of chronic gastrointestinal disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Contact with an immunosuppressed individual.
* 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 (pharmaceutical product or device).
* Chronic administration of immunosuppressants since birth.
* Gastroenteritis within 7 days preceding the first study vaccine administration.
* Documented HIV-positive subject.

Answer: C