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Hexavalent Vaccines in India: Current Status

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Abstract

Hexavalent vaccines containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, and hepatitis B virus antigens have the potential to be used for the primary series in India (6, 10, 14 weeks of age) and the toddler booster dose. Three hexavalent vaccines are available in India: DTwP-Hib/HepB-IPV (wP-hexa), DTaP-IPV-HB-PRP~T(2aP-hexa), and DTaP-HBV-IPV/Hib (3aP-hexa). In the three published phase-3 Indian studies, pertussis ‘vaccine response’ rates 1 month after a 6-10-14-week primary series were 68.4-75.7% for wP-hexa, 93.8-99.3% for 2aP-hexa, and 97.0-100% for 3aP-hexa; seroprotection rates for the other five antigens were 88.2-100%, 49.6-100%, and 98.6-100%, respectively. Studies outside India show: good immunogenicity/safety after boosting dosing; immune persistence to age 4.5 years (2aP-hexa), 7–9 years (3aP-hexa) (all antigens), and 9–10 and 14–15 years, respectively (hepatitis B); and successful co-administration with other vaccines. Hexavalent vaccines could reduce the number of injections, simplify vaccination schedules, and improve compliance.

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Acknowledgements

The authors would like to thank the Business & Decision Life Sciences platform for editorial assistance and manuscript coordination, on behalf of GSK. Thibaud André (Business & Decision Life Sciences) coordinated the manuscript development and provided editorial support. Jenny Lloyd (Compass Medical Communications Ltd.) provided writing support.

Funding

Funding: GlaxoSmithKline Biologicals SA took charge of all costs associated with the development and publication of this manuscript.

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Authors and Affiliations

  1. Department of Pediatrics, Max Superspeciality Hospital, Delhi, India

    Amar Jeet Chitkara

  2. Glaxo Smith Kline Biologicals SA, Mumbai, India

    Raunak Parikh & Shafi Kolhapure

  3. Glaxo Smith Kline Biologicals SA, Wavre, Belgium

    Attila Mihalyi

  4. GSK, Dr. Annie Besant Road, Mumbai, 400 030, Maharashtra, India

    Raunak Parikh

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  1. Amar Jeet Chitkara
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Contributors: All authors provided substantial intellectual and scientific input during manuscript development, critically reviewed the content, revised the manuscript, and approved the final version.

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Correspondence to Raunak Parikh.

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Competing interests: AC: has received lecture fees and advisory board fees from Sanofi Pasteur and Abbott Vaccines; RP,AM,SK: are employees of the GSK group of companies; AM: has received shares from the GSK group of companies.

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Trademarks: Hexaxim is a trademark of Sanofi Pasteur; Imovax Polio is a trademark of Sanofi Pasteur India Pvt. Ltd.; Pentavac SD is a trademark of Serum Institute of India Ltd.; EasySix is a trademark of Panacea Biotec Ltd.; Infanrix hexa and Infanrix are trademarks of the GSK group of companies.

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Chitkara, A.J., Parikh, R., Mihalyi, A. et al. Hexavalent Vaccines in India: Current Status. Indian Pediatr 56, 939–950 (2019). https://doi.org/10.1007/s13312-019-1651-y

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