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CLINICAL TRIAL article
Front. Immunol.
Sec. Vaccines and Molecular Therapeutics
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1550227
Immunogenicity and safety of a multi-human dose formulation of Biological E's 14-valent pneumococcal polysaccharide conjugate vaccine (PNEUBEVAX 14 TM ) administered to 6-8 weeks old healthy infants: A single blind, randomized, active-controlled, Phase-III study
Provisionally accepted
Subhash Thuluva 1
Ramesh V Matur 1* Subbareddy Gunneri 1 Rammohan Reddy Mogulla 1 Kamal Thammireddy 1 Kalyan Kumar Peta 1 Piyush Paliwal 1 Niranjana S Mahantshetti 2 Ramesh Kumar Banala 3 Prashanth Siddaiah 4- 1 Biological E Limited, Hyderabad, India
- 2 KLE Society Hospital, Belgaum, Karnataka, India
- 3 King George Hospital, Visakhapatnam, Andhra Pradesh, India
- 4 Mysore Medical College & Research Institute, Mysore, Karnataka, India
Pneumococcal conjugate vaccines (PCVs) have considerably reduced the burden of invasive pneumococcal disease (PD) worldwide. Consequently, though, there has been an increase in nonvaccine serotype-induced PD particularly at both the extremes of age. Biological E has developed a 14-valent PCV (PNEUBEVAX 14 TM ) that includes additional serotypes 22F and 33F. PNEUBEVAX 14 TM was shown to be safe, immunogenic, and non-inferior to Prevenar-13 TM (PCV-13) when administered to infants in a phase 3 pivotal trial. In this study, the multi-dose presentation of PNEUBEVAX 14 TM with 2-Phenoxyethanol as preservative was assessed for safety and immunogenicity in infants.This was a phase-3 single blinded, randomized, active-controlled study in 6-8 week old healthy infants, conducted at three sites across India. Safety and immunogenicity of multi-dose presentation of PNEUBEVAX 14 TM was assessed in a 6-10-14 week dosing schedule, with 300 infants randomized to receive either PNEUBEVAX 14 TM or PCV-13. Safety-wise, solicited local reactions and systemic events, unsolicited adverse events (AEs), serious AEs, and medically
Keywords: Vaccine, Pneumococcal conjugate vaccine, PCV, Serotype 6A, Infant immunization
Received: 23 Dec 2024; Accepted: 25 Feb 2025.
Copyright: © 2025 Thuluva, Matur, Gunneri, Mogulla, Thammireddy, Peta, Paliwal, Mahantshetti, Banala and Siddaiah. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Ramesh V Matur, Biological E Limited, Hyderabad, India
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.