Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02434770
• Date of registration: 30/04/2015
• Prospective Registration: Yes
• Primary sponsor: PATH
• Public title: Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
• Scientific title: 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
• Date of first enrolment: August 2015
• Target sample size: 750
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02434770
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Kenya

Contacts

• Name: Jessica Cowden, MD, MSPH
• Affiliation: US Army Medical Research Unit-Kenya

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 14 Days
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2

Biological: BioFarma Bivalent Oral Poliomyelitis Vaccine

Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1

Primary Outcome(s)

Number of Participants Experiencing Adverse Events [Time Frame: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).]

Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3 [Time Frame: 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 [Time Frame: 4 weeks post vaccination 4 (Week 18)]

Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity [Time Frame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)]

Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1 [Time Frame: Screening and 4 weeks post vaccination 4 (Week 18)]

Secondary Outcome(s)

Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection [Time Frame: 28 days after vaccination 4]

Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers [Time Frame: 4 weeks post vaccination 4 (Week 18)]

Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers [Time Frame: 4 weeks post vaccination 4 (Week 18)]

Secondary ID(s)

VAC-015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio

Results

• Results available: Yes
• Date Posted: 10/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02434770