Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413121
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-03
Brief Title:
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
Sponsor:
Serum Institute of India Pvt Ltd
Organization:
Serum Institute of India Pvt Ltd
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
This is an observer-blind randomized active-controlled multi-centric study in healthy infants and toddlers to assess the immunogenicity and safety of SIIPL reduced IPV hexavalent vaccine in comparison with the licensed SIIPL HEXASIIL vaccine
One thousand five hundred and fifty-seven infants aged 6-8 weeks 42 to 56 days both days inclusive will be randomized in a 21 ratio 1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL group to receive a 3-dose primary vaccination series followed by their booster doses respectively The safety and immunogenicity data collected up to 28 days following third vaccination ie Visit 7 shall be submitted to the regulatory authority All subjects will be followed up further for booster dose After Visit 7 ie 28 days following completion of primary vaccination series subjects will be followed up for safety every 3 months starting from the age of 6 months ie at 6 9 12 15 18 and 21 months of age until they receive the booster dose anytime between 12-24 months There will be post booster follow up visit EOS visit 28 days after the booster immunization ie Visit 10 to assess the safety and post booster immunogenicity
One thousand five hundred and fifty-seven infants aged 6-8 weeks 42 to 56 days both days inclusive will be randomized in a 21 ratio 1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL group to receive a 3-dose primary vaccination series followed by their booster doses respectively The safety and immunogenicity data collected up to 28 days following third vaccination ie Visit 7 shall be submitted to the regulatory authority All subjects will be followed up further for booster dose After Visit 7 ie 28 days following completion of primary vaccination series subjects will be followed up for safety every 3 months starting from the age of 6 months ie at 6 9 12 15 18 and 21 months of age until they receive the booster dose anytime between 12-24 months There will be post booster follow up visit EOS visit 28 days after the booster immunization ie Visit 10 to assess the safety and post booster immunogenicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None