Rotavirus
Conditions
Interventions
Trivalent subunit vaccine P2 VP8
Rotarix
Sponsors
PATH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy infants as established by medical history and clinical examination before randomization into the study Age: =6 and <8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) Parental ability and willingness to provide written informed consent Intention of the participants’ parents to remain in the area with the child during the study period
Exclusion criteria
Exclusion criteria: Acute disease at the time of enrollment/first study vaccination - temporary exclusion Presence of fever on the day of enrollment/first study vaccination (axillary temperature >37.6C) - temporary exclusion Concurrent participation in another clinical trial throughout the entire timeframe for this study (participation in non-interventional observational study is allowed if there is no blood draw) Presence of severe malnutrition (weight-for-height z-score =-3SD median (per WHO published child growth standards) 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 History of premature birth (<37 weeks gestation) and/or birth weight of <2.5 kg History of congenital abdominal disorders, intussusception, or abdominal surgery Prior receipt of rotavirus vaccine Known sensitivity or allergy to any components of the study vaccine Contraindications to any of the EPI/UIP vaccines History of anaphylactic reaction Major congenital or genetic defect Parents not able, available or willing to accept active weekly follow-up by the study staff Receipt of any immunoglobulin therapy and/or blood products History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (those on inhaled or topical steroids may be permitted to participate in the study) Any medical condition in the participant or parents that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a parents’ ability to give informed consent Exclusion of nursing infants whose mothers are receiving immunosuppressive biologics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory confirmed cases of Severe Rotavirus Gastroenteritis - SVRGE (any strain);Serious adverse events (SAEs), including intussusception;Adverse Events - AEs >grade 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory confirmed cases of VSRVGE - any strain;P-type specific laboratory confirmed cases of SRVGE and VSRGE;Laboratory confirmed cases of rotavirus gastroenteritis of any strain of any severity ;Laboratory confirmed cases of hospitalized for RVGE any severity;Incidence of SRVGE and VSRVGE per 100 children-years;Solicited local and systemic AEs ;SAEs, including intussusception;Anti-P2-VP8 IgA and IgG seroresponse rates by ELISA in assays using each of the three vaccine antigens ;Neutralizing antibody seroresponse rates to each of the three rotavirus strains from which the vaccine antigens are derived;Anti-P2-VP8 IgA and IgG geometric mean titers and geometric mean fold rises in ELISA assays using each of the three vaccine antigens | — |
Countries
Ghana, Malawi, Zambia
Contacts
Public ContactElayna Oberman
Communications
Outcome results
None listed