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

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.

Conditions

• Diptheria Immunization
• Tetanus Immunization
• Pertussis Immunization
• Hepatitis B Immunization
• Haemophilus Influenzae Type B Immunization
• Polio 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.

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.

  lead INDUSTRY

Principal Investigators

• Anand Kawade · KEM Hospital Research Centre, Pune, India

• Sonali Palkar · Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, India

• M D Ravi · JSS Hospitla, Mysore, India

• Veena Kamat · Manipal Academy of Higher Education, Kasturba Medical College, Udipi and Karkala,India

• P Umapathy · Sri Ramchndra Institute of Higher Education and Research, Chennai, India

• Kheya Ghosh · Institute of Child Health, Kolkata, India

• Madhu Gupta · Post Graduate Institute of Medical Education and Research, Chandigarh, India

• Afreen khan · Hamdard Institute of Medical Sciences and Research (HIMSR), New Delhi, India

• Deepali Ambike · Yashwantrao Chavan Memorial Hospital, Pimpri, Pune, India

• K Zaman · International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-06

Primary Completion

2025-08-31

Completion

2026-05-31

Countries

• Bangladesh
• India

Study Locations