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A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants.
Sharma, Hitt; Parekh, Sameer; Pujari, Pramod; Shewale, Sunil; Desai, Shivani; Kawade, Anand; Lalwani, Sanjay; Ravi, M D; Kamath, Veena; Mahopatra, Jagannath; Kulkarni, Ganesh; Tayade, Deepak; Ramanan, Padmasani Venkat; Uttam, Kheya Ghosh; Rawal, Lalit; Gawande, Avinash; Kumar, N Ravi; Tiple, Nishikant; Vagha, Jayant; Thakkar, Pareshkumar; Khandgave, Prashant; Deshmukh, Bhaskar Jedhe; Agarwal, Anurag; Dogar, Vikas; Gautam, Manish; Jaganathan, K S; Kumar, Rakesh; Sharma, Inderjit; Gairola, Sunil.
Afiliação
  • Sharma H; Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India. drhjs@seruminstitute.com.
  • Parekh S; Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
  • Pujari P; Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
  • Shewale S; Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
  • Desai S; Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., Pune, India.
  • Kawade A; Department of Pediatrics, KEM Hospital Research Centre, Vadu, Pune, India.
  • Lalwani S; Department of Pediatrics, Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Pune, India.
  • Ravi MD; Department of Pediatrics, JSS Hospital, Mysuru, India.
  • Kamath V; Department of Community Medicine, Kasturba Medical College, Manipal Academy of Higher Education (MAHE), Manipal, India.
  • Mahopatra J; Department of Pediatrics, Hamdard Institute of Medical Science and Research, New Delhi, India.
  • Kulkarni G; Department of Pediatrics, Sanjeevani Children's Hospital, Aurangabad, India.
  • Tayade D; Department of Pediatrics, Mahatma Gandhi Mission's Medical College and Hospital, Aurangabad, India.
  • Ramanan PV; Department of Pediatrics, Sri Ramachandra Hospital, Chennai, India.
  • Uttam KG; Department of Pediatrics, Institute of Child Health, Kolkata, India.
  • Rawal L; Department of Pediatrics, Grant Medical Foundation Ruby Hall Clinic, Pune, India.
  • Gawande A; Department of Pediatrics, Government Medical College and Hospital, Nagpur, India.
  • Kumar NR; Department of Pediatrics, Niloufer Hospital, Hyderabad, India.
  • Tiple N; Department of Pediatrics, Government Medical College, Chandrapur, India.
  • Vagha J; Department of Pediatrics, Acharya Vinoba Bhave Rural Hospital, Wardha, India.
  • Thakkar P; Department of Pediatrics, Sir Sayajirao General Hospital, Baroda, India.
  • Khandgave P; Department of Pediatrics, Pulse Multispeciality Hospital, Pune, India.
  • Deshmukh BJ; Department of Pediatrics, Baramati Hospital, Pune, India.
  • Agarwal A; Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital, New Delhi, India.
  • Dogar V; Department of Quality Control, Serum Institute of India Pvt. Ltd, Pune, India.
  • Gautam M; Department of Quality Control, Serum Institute of India Pvt. Ltd, Pune, India.
  • Jaganathan KS; Production Department, Serum Institute of India Pvt. Ltd, Pune, India.
  • Kumar R; Production Department, Serum Institute of India Pvt. Ltd, Pune, India.
  • Sharma I; Production Department, Serum Institute of India Pvt. Ltd, Pune, India.
  • Gairola S; Department of Quality Control, Serum Institute of India Pvt. Ltd, Pune, India.
NPJ Vaccines ; 9(1): 41, 2024 Feb 22.
Article em En | MEDLINE | ID: mdl-38383584
ABSTRACT
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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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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PubMed Links
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article