Phase 3
N=750
Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT02434770 ↗Enrolled (actual)
750
Serious AEs
6.1%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity — 187; 179; 175; 149 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 (Biological); BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 (Biological); BioFarma Bivalent Oral Poliomyelitis Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity |
187; 179; 175; 149; 139; 153 | — |
| PRIMARY Number of Participants Experiencing Adverse Events |
143; 142; 151; 111; 114; 117 | — |
| PRIMARY Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 |
40.9; 41.5; 41.2; 47.7; 55192; 65790 | — |
| PRIMARY Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 |
12.5; 15.6; 13.9; 14.3; 11374; 12390 | — |
| PRIMARY Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose |
223; 215; 438; 219; 223; 214 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers |
320; 322; 321; 267 | — |
| SECONDARY Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection |
192; 194; 386; 196 | 0.5586 |
| SECONDARY Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers |
22.7; 35.8; 28.3; 28.6 | — |
Summary
The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.
Eligibility Criteria
Inclusion Criteria
- Healthy, full-term infants, as established by medical history and clinical examination before entering into the study.
- Parents willing to provide written informed consent.
- Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through the 14th day of life, inclusive)
Exclusion Criteria
- Birth weight (as documented at first medical contact) less than 2.5 kg
- Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment (temporary exclusion)
- Presence of fever (> 37.5°C) on the day of enrollment (temporary exclusion)
- Acute disease at the time of enrollment (temporary exclusion)
- Significant malnutrition as per Investigator's judgment
- Concurrent participation in another clinical study at any time during the study period in which the infant will be exposed to an investigational or a non-investigational product
- Presence of any significant 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
- Known or suspected impairment of immunological function (including human immunodeficiency virus [HIV] exposure) based on medical history and physical examination
- Previous receipt of polio virus vaccine
- Household contact with a known immunosuppressed individual
- Unwillingness or inability of parents for active follow-up by the study staff
- History of any neurological disorders or seizures
- Any medical condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or a participant's ability to give informed consent
- Maternal HIV infection
Data sourced from ClinicalTrials.gov (NCT02434770). 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.