Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study. Issue 46 (5th November 2021)

• Record Type: Journal Article
• Authors: Lalwani, Sanjay Kewalchand; Ramanan, Padmasani Venkat; Sapru, Amita; Sundaram, Balasubramanian; Shah, Bela Hasmukh; Kaul, Dinesh; Karthik Nagesh, N.; Kalina, Warren V.; Chand, Rohit; Ding, Meichun; Suroju, Suresh; Scott, Daniel A.; Lockhart, Stephen P.
• Is Part Of: Vaccine. Volume 39:Issue 46(2021)
• Page Start: 6787
• Page End: 6795
• Publication Date: 2021-11-05
• Subjects: Vaccine -- Clinical trial -- Pneumococcal conjugate -- Children -- Infant -- Multidose; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.09.029
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: PCV13 formulated in a multidose vial (MDV) facilitates access to the vaccine. Immunogenicity and safety of PCV13-MDV in Indian infants and toddlers were evaluated. PCV13-MDV was safe and well tolerated when given with routine pediatric vaccines. PCV13-MDV elicited comparable immune responses to single dose formulated PCV13. Abstract: Purpose: This phase 4, randomized, open-label, multicenter study in healthy Indian infants and toddlers evaluated the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated in a multidose vial (MDV) or single prefilled syringe (PFS). Methods: Healthy Indian infants (6 weeks of age) were randomized 1:1 to receive either PCV13-MDV or PCV13-PFS concomitant with routine pediatric vaccines. Subjects received a single dose of either PCV13-MDV or PCV13-PFS as a 4-dose schedule (infant series: 1 dose at 6, 10, and 14 weeks of age; toddler dose: 12 months of age). Safety was assessed, including local reactions, systemic events, and adverse events (AEs). Immunogenicity 1 month after both the infant series and toddler dose was measured by concentrations of serotype-specific immunoglobulin G (IgG) antibodies and opsonophagocytic activity titers. Results: Rates and severities of local reactions and systemic events up to 7 days after each dose of either PCV13-MDV or PCV13-PFS were generally similar, with the majority being of mild or moderate severity. PCV13-MDV had a safety profile comparable with PCV13-PFS; both groups experienced a similar frequency of AEs. PCV13-MDV elicited immune responses comparable with those induced by PCV13-PFS. Clear boosting of immune responses after the PCV13-MDV toddler dose was observed; ≥96% of subjects showed serotype-specific IgG concentrations at or above the defined thresholds 1 month after the PCV13-MDV toddler dose. Conclusions: PCV13-MDV was safe, well tolerated, and immunogenic in healthy Indian infants and toddlers when coadministered with routine pediatric vaccinations. Safety and immunogenicity of PCV13-MDV was comparable with PCV13-PFS. Clinical Trial Registration: Clinicaltrials.gov: NCT03548337.