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

NCT02766816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1120

Last updated 2019-07-29

No results posted yet for this study

Summary

Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.

Conditions

  • Immune Response to Oral Polio Vaccine

Interventions

BIOLOGICAL

Part 1 study - BBio bOPV

A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 1

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 2

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - BBio bOPV Lot 3

Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 2 study - Licensed bOPV

Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.

BIOLOGICAL

Part 1 study - Licensed bOPV

A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.

Sponsors & Collaborators

  • Serum Institute of India Pvt. Ltd.

    collaborator INDUSTRY

  • Bilthoven Biologicals

    lead INDUSTRY

Principal Investigators

  • K Zaman, MBBS, MPH · International Center for Diarrheal Disease Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
83 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-08
Primary Completion
2018-02-14
Completion
2018-02-14

Countries

  • Bangladesh

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766816 on ClinicalTrials.gov