Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,557

Participants

Timeline

Start Date

May 6, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

May 31, 2026

Conditions
Diptheria ImmunizationTetanus ImmunizationPertussis ImmunizationHepatitis B ImmunizationHaemophilus Influenzae Type B ImmunizationPolio Immunization
Interventions
BIOLOGICAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

BIOLOGICAL

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV

Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.

Trial Locations (9)

128

RECRUITING

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Dhaka

110062

RECRUITING

Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH), New Delhi

160012

RECRUITING

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

411043

RECRUITING

Bharati Vidyapeeth Medical College and Hospital, Pune, Pune

412216

RECRUITING

KEM Hospital and Research Centre, Vadu, Pune

570004

RECRUITING

JSS Medical College and Hospital, Mysore

576104

RECRUITING

Manipal Academy of Higher Education, Manipal, Mangalore

600116

RECRUITING

Sri Ramachandra Medical Centre, Chennai, Chennai

700017

RECRUITING

Institute of Child Health, Kolkata, Kolkata

All Listed Sponsors
lead

Serum Institute of India Pvt. Ltd.

INDUSTRY