Phase 3
Completed N=450
Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia
Diarrhea · Diarrhea Rotavirus
Source: ClinicalTrials.gov NCT03602053 ↗
Enrolled (actual)
450
Serious AEs
1.4%
Results posted
Dec 2020
Primary outcomePrimary: Geometric Mean Concentration Using WC3 as the Viral Lysate — 18.1; 14.0 U/ml
Summary
The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks 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 with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration Using WC3 as the Viral Lysate |
18.1; 14.0 | — |
| SECONDARY Immediate Adverse Events |
1; 0; 1 | — |
| SECONDARY Solicited Adverse Events |
138; 136; 129; 110; 109; 100 | — |
| SECONDARY Unsolicited Adverse Events |
93; 95; 81; 10; 10; 6 | — |
| SECONDARY Serious Adverse Events |
2; 1; 3; 1; 0; 0 | — |
| SECONDARY Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate |
52; 41; 50 | — |
| SECONDARY Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate |
54; 42; 52 | — |
| SECONDARY Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate |
79; 65; 74; 71; 55; 66 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate |
4.6; 3.6; 3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infant as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record.
- Infants received age-appropriate EPI vaccines till enrolment.
- Ability and willingness to provide informed consent as per local consenting procedures.
- Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.
Exclusion Criteria
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- Presence of fever on the day of enrolment (temporary exclusion).
- Acute disease at the time of enrolment (temporary exclusion).
- Concurrent participation in another clinical trial throughout the entire timeframe of this study.
- Presence of severe malnutrition (weight-for-height z-score < -3SD median).
- 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 child's health or is likely to result in non-conformance to the protocol.
- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
- Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation.
- A known sensitivity or allergy to any component of the study vaccine.
- Clinically detectable significant congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea more than 14 days).
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any 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.
- History of any neurologic disorders or seizures.
- Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
- Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.
Data sourced from ClinicalTrials.gov (NCT03602053). 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. Informational only — not medical advice.