Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants
Brief Summary: This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.


Options:
A: Inclusion Criteria:

* Subjects' parent(s)/ Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 12 weeks of age at the time of the first dose of HRV vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born full-term as per the delivery records.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days before the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (≥ 0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of long-acting immune-modifying drugs at any time during the study period.
* Planned administration/administration of a vaccine not fore-seen by the study protocol within the period starting 30 days before the first dose of HRV vaccine administration and ending at Visit 7, with the exception of other routinely administered vaccines like PCV, Hib, BCG, hepatitis B, meningococcal vaccine and inactivated influenza vaccines, which are allowed at any time during the study, if administered at sites different from the sites used to administer the DPT-IPV vaccine.
* 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 vaccine/product.
* Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
* History of IS.
* Family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Major congenital defects or serious chronic illness.
* Previous vaccination against rotavirus, diphtheria, tetanus, pertussis and/ or poliovirus.
* Previous confirmed occurrence of RV GE, diphtheria, tetanus, pertussis, and/ or polio disease.
* GE within 7 days preceding the HRV vaccine administration.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the HRV or DPT-IPV vaccines.
* Hypersensitivity to latex.
* History of any neurological disorders or seizures.
* History of SCID.
* Acute disease and/or fever at the time of enrollment.

  * Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting.
  * Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
B: Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.
C: Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* None Specified
D: 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.

Answer: C