A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine (NCT03483116) | Clinical Trial Compass
CompletedPhase 2
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
Malawi711 participantsStarted 2018-06-15
Plain-language summary
The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.
Who can participate
Age range0 Days – 18 Weeks
SexALL
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Inclusion Criteria:
* Neonate is less than 6 days (≤144 hours) of age at the time of first dose.
* Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
* Neonate birth weight 2500-4000g inclusive.
* Neonate's parents/guardians expect to be available for the duration of the study, and agree to adhere to all protocol requirements.
* Neonate's parents/guardians have provided written informed consent prior to study-related procedures being performed.
Exclusion Criteria:
* Any medical, psychiatric, or social condition of a parent/guardian that in the opinion of the investigator would prevent the neonate's parents/guardians from giving proper informed consent or from complying with the study protocol.
* Neonates with known or suspected major congenital malformations or genetically determined disease.
* Neonates with intussusception.
* Neonates with a known or suspected bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Neonates who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of the study is anticipated.
* Neonates in whom Essential Programme Immunisation (EPI) vaccines or components are contraindicated.
* Neonates who have received or who expect to receive during the study period, any rotavirus vacc…
What they're measuring
1
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB
Timeframe: At serum collection at approximately 14 weeks of age