Phase 2
N=711
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
Rotavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT03483116 ↗Enrolled (actual)
711
Serious AEs
4.5%
Results posted
Jul 2023
Primary outcome: Primary: 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 — 79; 80; 57 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RV3-BB (Biological); Placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Murdoch Childrens Research Institute
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
79; 80; 57 | — |
| SECONDARY Number of Participants With a Cumulative Anti Rotavirus Serum IgA Response (≥3 Fold Increase From Baseline) After 3 Doses in an Infant RV3-BB Schedule |
100; 96; 86; 82 | — |
| SECONDARY Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule |
48.4; 39.9; 28.0; 77.7 | — |
| SECONDARY Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB. |
118; 120; 79; 82; 85; 90 | — |
| SECONDARY Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB |
114; 94; 80; 57; 71; 62 | — |
| SECONDARY Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB |
98; 89; 68; 98; 56; 55 | — |
| SECONDARY Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB |
51; 45; 23; 64; 31; 31 | — |
| SECONDARY Occurrence of Adverse Events (AE) |
67; 68; 69; 60 | — |
| SECONDARY Occurrence of Serious Adverse Events (SAEs) |
11; 7; 8; 5 | — |
| SECONDARY Occurrence of Diarrhea. Severe |
1; 2; 2; 0 | — |
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.
Eligibility Criteria
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 vaccine other than those which will be administered as part of this study.
- Neonates who have ever received, or who are anticipated to receive during the study period, any investigational agent other than those which will be administered as part of this study.
- Neonates with a previous anaphylactic reaction to any drug, vaccine or vaccine component.
- Neonates with a significant evolving neurological disorder.
- Neonates whose parents/guardians are site team employees with direct involvement with the investigators, or who are working on the study.
- Neonates who have been exposed to immunosuppressive courses of glucocorticosteroids, cytotoxic drugs or blood products through prenatal exposure and/or breast milk in the four weeks prior to randomization.
- Neonates with diarrhoea or vomiting in the 24 hours preceding randomisation.
- Neonates with any moderate or severe illness, and/or who have a temperature of ≥37.5˚C axillary/oral or ≥38˚C rectal/tympanic within the 48 hours preceding randomization.
Data sourced from ClinicalTrials.gov (NCT03483116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.