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RECRUITING
NCT06413121
PHASE3

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

Sponsor: Serum Institute of India Pvt. Ltd.

View on ClinicalTrials.gov

Summary

In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV. SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens. Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.

Official title: An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL®

Key Details

Gender

All

Age Range

6 Weeks - 8 Weeks

Study Type

INTERVENTIONAL

Enrollment

1557

Start Date

2024-05-06

Completion Date

2026-05-31

Last Updated

2024-09-19

Healthy Volunteers

Yes

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.

Locations (9)

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

Dhaka, Bangladesh

Manipal Academy of Higher Education, Manipal

Mangalore, Karnataka, India

JSS Medical College and Hospital

Mysore, Karnataka, India

Bharati Vidyapeeth Medical College and Hospital, Pune

Pune, Maharashtra, India

KEM Hospital and Research Centre, Vadu

Pune, Maharashtra, India

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, National Capital Territory of Delhi, India

Sri Ramachandra Medical Centre, Chennai

Chennai, Tamil Nadu, India

Institute of Child Health, Kolkata

Kolkata, West Bengal, India

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India