Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase I/II Double-blind, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study of the Safety, and Immunogenicity of the Trivalent P2-VP8 Subunit Rotavirus Vaccine in Healthy South African Adults, Toddlers and Infants
Brief Summary: This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group.

The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.


Options:
A: Inclusion Criteria:

* Child 9 months of age eligible for measles-rubella vaccination
* documented evidence of a primary rotavirus vaccine series with first dose between 6 and 10 weeks of age and second dose at least 4 weeks after first dose
* healthy infants free of chronic or serious medical condition as determined by history and physical examination at time of study enrollment
* parents/guardians of each participant are able to understand and follow study procedures and agree to participate in study by providing signed informed consent

Exclusion Criteria:

* hypersensitivity to any component of measles-rubella or Rotarix vaccine which would preclude administration of the vaccine
* history of intussusception, intestinal malformations, or abdominal surgery
* known history of measles and/or rubella disease
* history of previous receipt of measles and/or rubella vaccine
* use of any immunosuppressive drugs or immunoglobulin and/or blood products since birth or anticipated during study period
* current enrolment in any other intervention trial or use of any investigational drug or vaccine throughout the study period
* any participant who reports planning to leave the study area before the completion of the study
* acute diarrhea (defined as ≥3 loose stools within a 24-hour period) or vomiting (defined as projectile vomiting or any vomiting at the discretion of the clinician) at the time of enrollment or within the last 24 hours
* acute febrile illness (defined as a temperature of ≥38°C) at the time of enrollment.
B: Inclusion Criteria:

* A male or female infant at least 6 weeks of age and not older than 20 weeks of age at the time of first dose of Rotarix.
* An infant whose parent or guardian's primary residence, at the time of first EPI vaccinations, is a village selected to receive Rotarix.
* Written informed consent obtained from the parent or guardian of the subject, prior to the subject's first study vaccination

Exclusion Criteria:

* Hypersensitivity to the active substance or any component in the vaccine
* Hypersensitivity after previous administration of rotavirus vaccines.
* Previous history of intussusception.
* Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
* Infants with known or suspected immunodeficiency.
* Administration of Rotarix should be postponed in subjects suffering from an acute severe febrile illness only if that illness also results in postponement of other EPI vaccinations.
C: Inclusion Criteria:

* 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.
* Healthy male or female infant between, and including, 6 and 14 weeks (42 - 104 days) of age at the time of first study vaccination in Portugal, France and Poland. A male or female infant between, and including, 6 and 12 weeks of age at the time of first study vaccination in Spain.
* Medically stable pre-term infants, born within a gestational period of 27 -36 weeks.
* Written informed consent obtained from the parent or guardian of the subject.
* Planned to be discharged from hospital's neonatal stay on or before the day of the first HRV vaccine/Placebo administration.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccines not foreseen by the study protocol from birth till study end.
* 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).
* Any clinically significant history of chronic gastrointestinal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness (subjects with severe broncho-pulmonary dysplasia requiring persistent oxygen-therapy will be excluded).
* History of any neurologic disorders or seizures. Grade I and II intra-ventricular bleeding are allowed.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins, and/or any blood products within one month (30 days) preceding the first dose of study vaccines or planned administration during the study period. Monoclonal anti-RSV therapy/prophylaxis and recombinant erythropoietin are allowed.
D: Inclusion Criteria:

* Healthy adults (≥ 18 and ≤ 45 years), toddlers (≥ 2 and ≤ 3 years), and infants (≥ 6 and ≤ 8 weeks)
* Participants will remain in the area during the study
* Females of childbearing potential must not be pregnant or breastfeeding, and willing to use adequate method of contraception during the trial.

Exclusion Criteria:

* Presence of fever or other acute illness
* concurrent participation in another clinical trial
* Presence of malnutrition or other systemic disorder.
* Infants with history of premature birth (\< 37 week gestational age)
* History of congenital abdominal disorders or surgery
* Suspected or known impairment of immune function
* Infants who have received rotavirus vaccine in the past
* Known sensitivity to any components of the vaccine
* History of anaphylactic reaction
* Major congenital or genetic defect
* Unwillingness to follow study schedule
* Receipt of immunoglobulin therapy or blood products in last 6 months
* History of chronic immunosuppressive medications (with the exception of inhaled or topical steroids)
* Any medical condition that, in the judgement of the investigator, would interfere with the protocol, or would interfere with participant's ability to adhere to the study protocol.
* Clinically significant screening laboratory value
* Human immunodeficiency virus (HIV) infection

Answer: D