Bivalent Oral Polio Vaccine in healthy infants- A Phase IV study

A phase IV, interventional, open label, multicentric, single arm clinical trial to assess the safety, tolerability & immunogenicity of bivalent oral polio vaccine (bOPV) in healthy Indian infants - STI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/02/007813

Enrollment

1000

Registered

2017-02-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bivalent Oral Polio Vaccine (bOPV, Type 1 and 3) from BIBCOL: Test vaccine will be administered orally (2 drops or 0.1ml) at birth, then after 6-8 weeks and then 2 doses will be adminis

Eligibility

Inclusion criteria

Inclusion criteria: Newborn infants with an APGAR score > 7 when measured 1 minute after birth Infants who have not been previously vaccinated against poliomyelitis Infants born at full term pregnancy with a birth weight >= 2.5 Kg

Exclusion criteria

Exclusion criteria: Infants born before the 37th week of gestation or weighing less then 2.5 kg at birth. History of immunization with â??zero doseâ?? of OPV. Newborn infants who are participating in any other investigatory study. Newborn infants currently receiving immuno suppressant drugs.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of Bivalent Oral Polio Vaccine (bOPV, Type 1 & 3) in healthy Indian infants.Timepoint: six months	—

Secondary

Measure	Time frame
To assess the immunogenicity of Bivalent Oral Polio Vaccine (bOPV, Type 1 and 3) in healthy Indian infantsTimepoint: 12 months	—

Countries

India

Contacts

Public ContactS K Tyagi

Bharat Immunologicals and Biologicals Corporation Limited

tskindira@gmail.com9458096104

Outcome results