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®

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1 month
Healthy Volunteers: t
View:

• Male or female infants aged 6-8 weeks at the time of first vaccination.

• Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.

• Informed consent form signed by at least one parent.

• Infants born at full term pregnancy (≥ 37 weeks).

• Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment.

• Willingness of subjects' parent to comply with the requirements of the protocol.

Locations
Other Locations
Bangladesh
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
RECRUITING
Dhaka
India
Post Graduate Institute of Medical Education and Research (PGIMER)
RECRUITING
Chandigarh
Sri Ramachandra Medical Centre, Chennai
RECRUITING
Chennai
Institute of Child Health, Kolkata
RECRUITING
Kolkata
Manipal Academy of Higher Education, Manipal
RECRUITING
Mangalore
JSS Medical College and Hospital
RECRUITING
Mysore
Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH)
RECRUITING
New Delhi
Bharati Vidyapeeth Medical College and Hospital, Pune
RECRUITING
Pune
KEM Hospital and Research Centre, Vadu
RECRUITING
Pune
Contact Information
Primary
Hitt Sharma
drhjs@seruminstitute.com
+912026602451
Backup
Sameer Parekh
sameer.parekh@seruminstitute.com
+912026602139
Time Frame
Start Date: 2024-05-06
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 1557
Treatments
Experimental: 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 a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.
Active_comparator: 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 a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.
Sponsors
Leads: Serum Institute of India Pvt. Ltd.

This content was sourced from clinicaltrials.gov

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