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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
by
Gairola, Sunil
, Sharma, Inderjit
, Khandgave, Prashant
, Ravi, M. D.
, Kawade, Anand
, Jaganathan, K. S.
, Pujari, Pramod
, Kamath, Veena
, Deshmukh, Bhaskar Jedhe
, Gawande, Avinash
, Desai, Shivani
, Kulkarni, Ganesh
, Vagha, Jayant
, Lalwani, Sanjay
, Thakkar, Pareshkumar
, Ramanan, Padmasani Venkat
, Gautam, Manish
, Kumar, N. Ravi
, Sharma, Hitt
, Shewale, Sunil
, Agarwal, Anurag
, Rawal, Lalit
, Kumar, Rakesh
, Parekh, Sameer
, Uttam, Kheya Ghosh
, Tiple, Nishikant
, Mahopatra, Jagannath
, Dogar, Vikas
, Tayade, Deepak
in
631/250/590
/ 692/308/2779/109/1942
/ 692/308/2779/777
/ Antibodies
/ Antigens
/ Babies
/ Biomedical and Life Sciences
/ Biomedicine
/ Clinical trials
/ Diphtheria
/ Erythema
/ Hepatitis B
/ Immunity (Disease)
/ Immunogenicity
/ Infants
/ Infectious Diseases
/ Medical Microbiology
/ Patient safety
/ Pediatrics
/ Poliomyelitis
/ Public Health
/ Tetanus
/ Vaccine
/ Vaccines
/ Virology
/ Whooping cough
2024
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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
by
Gairola, Sunil
, Sharma, Inderjit
, Khandgave, Prashant
, Ravi, M. D.
, Kawade, Anand
, Jaganathan, K. S.
, Pujari, Pramod
, Kamath, Veena
, Deshmukh, Bhaskar Jedhe
, Gawande, Avinash
, Desai, Shivani
, Kulkarni, Ganesh
, Vagha, Jayant
, Lalwani, Sanjay
, Thakkar, Pareshkumar
, Ramanan, Padmasani Venkat
, Gautam, Manish
, Kumar, N. Ravi
, Sharma, Hitt
, Shewale, Sunil
, Agarwal, Anurag
, Rawal, Lalit
, Kumar, Rakesh
, Parekh, Sameer
, Uttam, Kheya Ghosh
, Tiple, Nishikant
, Mahopatra, Jagannath
, Dogar, Vikas
, Tayade, Deepak
in
631/250/590
/ 692/308/2779/109/1942
/ 692/308/2779/777
/ Antibodies
/ Antigens
/ Babies
/ Biomedical and Life Sciences
/ Biomedicine
/ Clinical trials
/ Diphtheria
/ Erythema
/ Hepatitis B
/ Immunity (Disease)
/ Immunogenicity
/ Infants
/ Infectious Diseases
/ Medical Microbiology
/ Patient safety
/ Pediatrics
/ Poliomyelitis
/ Public Health
/ Tetanus
/ Vaccine
/ Vaccines
/ Virology
/ Whooping cough
2024
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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
by
Gairola, Sunil
, Sharma, Inderjit
, Khandgave, Prashant
, Ravi, M. D.
, Kawade, Anand
, Jaganathan, K. S.
, Pujari, Pramod
, Kamath, Veena
, Deshmukh, Bhaskar Jedhe
, Gawande, Avinash
, Desai, Shivani
, Kulkarni, Ganesh
, Vagha, Jayant
, Lalwani, Sanjay
, Thakkar, Pareshkumar
, Ramanan, Padmasani Venkat
, Gautam, Manish
, Kumar, N. Ravi
, Sharma, Hitt
, Shewale, Sunil
, Agarwal, Anurag
, Rawal, Lalit
, Kumar, Rakesh
, Parekh, Sameer
, Uttam, Kheya Ghosh
, Tiple, Nishikant
, Mahopatra, Jagannath
, Dogar, Vikas
, Tayade, Deepak
in
631/250/590
/ 692/308/2779/109/1942
/ 692/308/2779/777
/ Antibodies
/ Antigens
/ Babies
/ Biomedical and Life Sciences
/ Biomedicine
/ Clinical trials
/ Diphtheria
/ Erythema
/ Hepatitis B
/ Immunity (Disease)
/ Immunogenicity
/ Infants
/ Infectious Diseases
/ Medical Microbiology
/ Patient safety
/ Pediatrics
/ Poliomyelitis
/ Public Health
/ Tetanus
/ Vaccine
/ Vaccines
/ Virology
/ Whooping cough
2024
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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
Journal Article
A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants
2024
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Overview
A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and
Haemophilus influenzae
type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL
®
) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.
Clinical Trial Registration
–
CTRI/2019/11/022052
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