Please select the eligibility criteria that correspond to the clinical trial below.
Title: Compare the Immunogenicity, Reactogenicity & Safety of 2 Different Formulations of GSK Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV
Brief Summary: Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. A new formulation of the vaccine, with an alternative buffer, was developed. This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine.


Options:
A: Inclusion Criteria:

* Subjects with parents/guardians who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
* Males or females between, and including, 6 and 12 weeks (42 - 90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subjects.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Use of any investigational or non-registered product (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.
* Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
* 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition, as determined by the investigator.
* History of allergic diseases or reactions likely to be exacerbated by any component of the vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* Major congenital defects or serious chronic illnesses.
* Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever, i.e. temperature \>= 37.5°C as measured by an axillary thermometer or \>= 38.0°C as measured by a rectal thermometer.) Temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
* Gastroenteritis (GE) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
* Household contact with an immunosuppressed individual or pregnant woman.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Previous confirmed occurrence of RV GE.
* History of neurological disorders or seizures.
B: Inclusion Criteria:

* Healthy infants, aged from 6 weeks through full 7 weeks,
* Consent form signed by at least one parent or by the legal representative properly informed about the study,
* Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

* History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
* Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
* Known or suspected impairment of immunological function,
* Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
* Prior administration of any rotavirus vaccine,
* Prior administration of any vaccine within the 28 days prior to randomisation,
* Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
* History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Clinical evidence of active gastrointestinal illness,
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
* Infants residing in a household with an immunocompromised person,
* Prior receipt of a blood transfusion or blood products, including immunoglobulins.
C: Inclusion Criteria:

* Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol.
* A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents/Legally Acceptable Representatives of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccine 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 since birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after the first dose of the human rotavirus vaccine or placebo except for the routine childhood vaccinations.
* 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.
* Any clinically significant history of gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception .
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of confirmed rotavirus gastroenteritis.
* Acute disease and/or fever at the time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine or placebo administration.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

In addition to the criteria mentioned above, the following criteria will be applicable to all subjects in the immunogenicity subgroup 2:

* History of diphtheria, tetanus and pertussis disease.
* History of seizures or progressive neurological disease.
* Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis.
D: Inclusion Criteria:

* healthy infants/toddlers as established by medical history and clinical examination before entering study
* age:

  * toddler cohort: \> or = 2 and \<3 years old at the time of enrollment
  * infant cohort: \> or = 6 and \<8 weeks at the time of enrollment
* parental ability and willingness to provide informed consent
* parental intention to remain in the area with the child during the study period.

Exclusion Criteria:

* Presence of fever on the day of enrollment
* Acute disease at the time of enrollment
* Concurrent participation in another clinical trial throughout the entire timeframe for this study
* Presence of malnutrition 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 that would compromise the participant's health or is likely to result in nonconformance to the protocol
* For infant cohort, history of premature birth (\<37 weeks gestation)
* History of congenital abdominal disorders, intussusception, or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination
* For infant cohort only, prior receipt of rotavirus vaccine
* A known sensitivity or allergy to any components of the study vaccine
* History of anaphylactic reaction
* Major congenital or genetic defect
* 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 immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
* Any medical condition in the parents/infant that, 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
* HIV infection

  * For toddlers, to be assessed by HIV ELISA
  * For infants, to be assessed by PCR, if mother is not known to be negative (negative test result between 24 weeks gestation and screening)

Answer: A