Phase 3
N=825
Phase III Study of Liquid Formulation of ROTAVIN
Diarrhea · Diarrhea Rotavirus
Bottom Line
View on ClinicalTrials.gov: NCT03703336 ↗Enrolled (actual)
825
Serious AEs
4.5%
Results posted
Jan 2021
Primary outcome: Primary: Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination — 48.25; 35.04 U/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ROTAVIN (liquid formulation) (Biological); ROTAVIN-M1 (frozen formulation) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) of Serum Anti-rotavirus Immunoglobulin A (IgA) Antibodies 28 Days After Second Vaccination |
48.25; 35.04 | — |
| PRIMARY Number of Participants With Solicited Reactions Within 7 Days of Vaccination |
195; 102; 37; 23; 57; 27 | — |
| SECONDARY Percentage of Participants With Seroconversion 28 Days After the Second Vaccination |
70.4; 64.4 | — |
| SECONDARY Percentage of Participants With Seropositivity at Baseline and 28 Days After the Second Vaccination |
0.4; 0.0; 70.8; 64.4 | — |
| SECONDARY Number of Participants With Immediate Adverse Events (AEs) |
2; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With Unsolicited Adverse Events |
292; 154; 191; 103; 132; 63 | — |
| SECONDARY Number of Participants With Serious Adverse Events Including Intussusception |
23; 14; 3; 3; 20; 11 | — |
Summary
This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age.
The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination.
Eligibility Criteria
Inclusion Criteria
- Healthy infants as established by medical history and clinical examination before entering the study.
- Age: 60-91 days (both days inclusive) at the time of enrollment.
- Parental/legally acceptable representative ability and willingness to provide written informed consent.
- Parent/legally acceptable representative who intends to remain in the area with the child during the study period.
Exclusion Criteria
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever on the day of enrollment (temporary exclusion).
- Acute disease at the time of enrollment (temporary exclusion).
- Concurrent participation in another clinical trial at any point throughout the entire time frame for this study.
- Presence of significant malnutrition (weight-for-height z-score < -3 SD median)
- Presence of 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 which would compromise the participant's health or is likely to result in nonconformance to the protocol.
- History of congenital abdominal disorders, intussusception, or abdominal surgery.
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Household contact with an immunosuppressed individual or pregnant woman.
- Prior receipt of rotavirus or an intent to receive this vaccine from outside of the study center during study participation.
- Prior receipt of Expanded Program on Immunization (EPI) vaccination during past 7 days or plan to receive them within next 7 days.
- A known sensitivity or allergy to any components of the study vaccine.
- History of allergy to antibiotic kanamycin.
- Clinically detectable significant congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
- Receipt of 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 immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- Any medical condition in the parent/legally acceptable representative or infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.
Data sourced from ClinicalTrials.gov (NCT03703336). 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.