Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
A Phase III Single-blind, Randomized, Controlled Study in Healthy Kenyan Infants to Assess the Immunogenicity and Safety of Beijing TiantanBio Liquid Bivalent Oral Poliomyelitis Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV
1 other identifier
interventional
750
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2016
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2020
February 1, 2020
11 months
April 30, 2015
September 14, 2018
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity
Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as: Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant.
7 days after each vaccination (Weeks 0, 6, 10, and 14)
Number of Participants Experiencing Adverse Events
Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant.
From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Screening and 4 weeks post vaccination 4 (Week 18)
Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Screening and 4 weeks post vaccination 4 (Week 18)
Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days).
4 weeks post vaccination 4 (Week 18)
Secondary Outcomes (3)
Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers
4 weeks post vaccination 4 (Week 18)
Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection
28 days after vaccination 4
Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers
4 weeks post vaccination 4 (Week 18)
Study Arms (3)
BBIBP bOPV Lot 1
EXPERIMENTALInfants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
BBIBP bOPV Lot 2
EXPERIMENTALInfants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
BioFarma bOPV
ACTIVE COMPARATORInfants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age.
Interventions
Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 cell culture infectious dose 50% (CCID50)/dose and 10\^5.8 CCID50/dose, respectively.
Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10\^6 CCID50/dose and 10\^5.8 CCID50/dose, respectively.
Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10\^6 and 10\^5.8 infective units per dose, respectively.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Birth weight (as documented at first medical contact) less than 2.5 kg
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kenya Medical Research Institute/Walter Reed Project
Kisumu, Nyanza, PO Box 54-40100, Kenya
Kenya Medical Research Institute (KEMRI)/Walter Reed Project
Kericho, Kenya
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jorge Flores
- Organization
- PATH
Study Officials
- STUDY CHAIR
Jessica Cowden, MD, MSPH
US Army Medical Research Unit-Kenya
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 5, 2015
Study Start
August 1, 2015
Primary Completion
June 17, 2016
Study Completion
June 17, 2016
Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-02