A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02766816
• Date of registration: 06/05/2016
• Prospective Registration: Yes
• Primary sponsor: Bilthoven Biologicals
• Public title: A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals
• Scientific title: A Phase III, Observer Blind, Active Controlled, Randomized, Clinical Study Comparing Safety and Immunogenicity of BBio Bivalent Oral Polio Vaccine With a Licensed Bivalent Oral Polio Vaccine
• Date of first enrolment: June 8, 2016
• Target sample size: 1120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02766816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bangladesh

Contacts

• Name: K Zaman, MBBS, MPH
• Affiliation: International Center for Diarrheal Disease Research

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Normal healthy children of both sexes of age 5 to 6 years (60-83 months) at the time
of vaccination and who have received at least 3 doses of trivalent oral polio vaccine
(tOPV) based upon documentation (Study Part 1).

2. Normal healthy infants of both sexes of age 6-8 weeks (42-56 days) at the time of the
first vaccination and have not received oral polio vaccine (OPV) previously based upon
documentation (Study Part 2).

3. Parents/legal guardians of participants willing to give written informed consent and
willing to comply with study protocol.

4. Free of obvious health problems as established by medical history and screening
evaluation including clinical examination.

5. Resident of study area.

Exclusion Criteria:

1. Participation in another clinical trial in the 4 weeks preceding the (first) trial
vaccination or planned participation in another clinical trial during the present
trial period.

2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder,
malignancy, receiving immunosuppressive therapy such as systemic corticosteroids
therapy for a period of = 1 week either in the participant or in an immediate family
member.

3. A diagnosis or suspicion of bleeding disorder that would contraindicate collection of
blood by venipuncture.

4. Acute or persistent diarrhea (defined as diarrhea that lasts 14 days or longer),
infection or illness at the time of enrollment (6-8 weeks of age) that would require
participant's admission to a hospital or would contraindicate provision of OPV.

5. Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit.

6. Infants from multiple births (i.e. twins).

7. History of allergy or systemic hypersensitivity to any of the vaccine components or
history of a life-threatening reaction to the study vaccines or a vaccine containing
the same substances.

8. Chronic illness at a stage that could interfere with trial conduct or completion.

9. Planned administration/ administration of a vaccine not foreseen by the study protocol
during the study period with the exception of routine Expanded Program on Immunization
(EPI) program vaccines including pneumococcal vaccine, and rotavirus vaccine (Polio
vaccines are not allowed during the study period).

10. Blood or blood-derived products received in the past.

11. Any vaccination one week preceding the trial vaccination.

12. Presence of significant malnutrition (< -3 standard deviation [SD] weight for length)
or acute or chronic, clinically significant pulmonary, endocrine, autoimmune,
cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by
medical history, and physical examination, which in the opinion of the investigator,
might interfere with the study objectives

13. History of any neurological disorder or history of seizure (febrile or afebrile), or
encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

14. Febrile illness or acute illness on the day of inclusion is temporary exclusion
criterion.

15. Participant with any other condition, which, in the opinion of the investigator would
jeopardize the safety or rights of the participant participating in the study or
making it unlikely the participant, could complete the protocol.



Age minimum: 42 Days
Age maximum: 83 Months
Gender: All

Health Condition(s) or Problem(s) studied

Immune Response to Oral Polio Vaccine

Intervention(s)

Biological: Part 2 study - Licensed bOPV

Biological: Part 2 study - BBio bOPV Lot 3

Biological: Part 2 study - BBio bOPV Lot 1

Biological: Part 1 study - BBio bOPV

Biological: Part 1 study - Licensed bOPV

Biological: Part 2 study - BBio bOPV Lot 2

Primary Outcome(s)

Part 1 study: Frequency of adverse events (AEs) [Time Frame: 4 Days]

Part 2 study: Percentage of seroconversion to poliovirus type 1 and type 3 [Time Frame: one month after dose 3]

Part 1 study: Frequency of AEs and serious AEs (SAEs) [Time Frame: 28 days]

Secondary Outcome(s)

Part 2 study: GMTs of serum PVNA for the three lots of BBio bOPV [Time Frame: one month after dose 3]

Part 2 study: Percentage of seroprotection to poliovirus type 1 and type 3 [Time Frame: one month after dose 3]

Part 1 study: Geometric mean titers (GMTs) of poliovirus neutralizing antibody (PVNA) to poliovirus type 1 and type 3 [Time Frame: one month]

Part 2 study: Frequency of adverse events and serious adverse events [Time Frame: 84 days]

Part 2 study: GMTs of PVNA to poliovirus type 1 and type 3 [Time Frame: one month after dose 3]

Part 1 study: Percentage of seroprotection to poliovirus type 1 and type 3 [Time Frame: one month]

Part 2 study: Frequency of adverse events within 4 days following the administration of each dose of vaccine [Time Frame: 4 days after each dose of vaccine]

Secondary ID(s)

OPV-03/PR-15106

PR-15106

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Serum Institute of India Pvt. Ltd.