Safety, Immunogenicity of Co-Administered Vaccines, and Lot-to-Lot Consistency of a 14-Valent Pneumococcal Conjugate Vaccine (PNEUBEVAX 14®) Administered at 6–10–14 Weeks in Healthy Infants: A Multicenter, Phase IV Trial
Year: 2026
Type: article
Abstract: Background: Pneumococcal conjugate vaccines (PCVs) have substantially reduced pneumococcal disease in children; however, serotype distribution varies geographically, and residual disease due to non-PCV13 serotypes persists. Biological E’s PNEUBEVAX 14® (BE-PCV14), a WHO-prequalified 14-valent PCV, expands coverage by including serotypes 22F and 33F. As PCVs are co-administered with routine Expanded Programme on Immunization (EPI) vaccines, post-licensure data on safety, co-administration, and lot-to-lot consistency are essential. This multicenter phase IV study evaluated BE-PCV14 in healthy PCV-naïve infants aged 6–8 weeks across 31 sites in India. Methods: A total of 2600 infants were enrolled and vaccinated at 6, 10, and 14 weeks of age; 2300 received BE-PCV14 and 300 received PCV13. All participants received concomitant DTwP-HepB-IPV-Hib and oral rotavirus vaccines per routine schedule. Safety was assessed through solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs). Immunogenicity subsets evaluated responses to co-administered vaccines and serotype-specific responses across three BE-PCV14 lots. Results: Among 2600 vaccinated infants, at least one AE occurred in 26.35% (95% CI: 24.59, 28.19) of BE-PCV14 and 24.67% (95% CI: 20.13, 29.84) of PCV13 recipients; most were mild. Injection-site pain and pyrexia were the most common events. Immune responses to co-administered vaccines were comparable between groups and met the non-inferiority criteria: lower bound of the two-sided 95% CI > −10 percentage points for seroprotection/seroconversion rate differences using the Farrington–Manning method. Lot-to-lot consistency was demonstrated, with all GMC ratios within the predefined equivalence margin (0.5–2.0). Conclusions: BE-PCV14 was well tolerated. Immune responses to co-administered routine EPI vaccines met predefined non-inferiority criteria, supporting the interpretation that BE-PCV14 did not result in clinically meaningful immune interference. Consistent immune responses across manufacturing lots further support its use in infant immunization programs.
Source: Vaccines
Authors: Subhash Thuluva, Subbareddy Gunneri, Siddalingaiah Ningaiah, Vijay Yerroju, Rammohan Reddy Mogulla, Kamal Thammireddy, Chirag Dhar, Shivani Desai, Piyush Paliwal, Chandrudu Loka, Nagaganesh Balne, Suresh Kommanapalli, Chinmayi Joshi, Kishori Sharan Agarwal, Girish P. Charde, Manish Narang, Jai Prakash Narayan, Bheemisetty S. Chakravarthy, Niranjana S. Mahantshetti, Pramod Prabhakar Jog, Prashanth Madapura Virupakshappa, Savita Verma, Madhukar Pandey, Pareshkumar A. Thakkar
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,258
OpenAlex ID: W7162113424