PMID- 34656378 OWN - NLM STAT- MEDLINE DCOM- 20220126 LR - 20220126 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 39 IP - 46 DP - 2021 Nov 5 TI - 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. PG - 6787-6795 LID - S0264-410X(21)01208-1 [pii] LID - 10.1016/j.vaccine.2021.09.029 [doi] AB - 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. CI - Copyright (c) 2021 Elsevier Ltd. All rights reserved. FAU - Lalwani, Sanjay Kewalchand AU - Lalwani SK AD - Department of Pediatrics, Bharati Vidyapeeth Medical College and Hospital, Pune, Maharashtra, India. FAU - Ramanan, Padmasani Venkat AU - Ramanan PV AD - Department of Pediatrics, Sri Ramachandra Hospital, Chennai, Tamil Nadu, India. FAU - Sapru, Amita AU - Sapru A AD - Department of Pediatrics, KEM Hospital Research Centre, Pune, Maharashtra, India. FAU - Sundaram, Balasubramanian AU - Sundaram B AD - Department of Pediatrics, Kanchi Kamakoti CHILDS Trust Hospital, Chennai, Tamil Nadu, India. FAU - Shah, Bela Hasmukh AU - Shah BH AD - Department of Pediatrics, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India. FAU - Kaul, Dinesh AU - Kaul D AD - Department of Pediatrics, Sir Ganga Ram Hospital, New Delhi, India. FAU - Karthik Nagesh, N AU - Karthik Nagesh N AD - Department of Pediatrics, Manipal Hospital, Bengaluru, Karnataka, India. FAU - Kalina, Warren V AU - Kalina WV AD - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA. FAU - Chand, Rohit AU - Chand R AD - Global Site and Study Operations, Pfizer Ltd, Mumbai, India. FAU - Ding, Meichun AU - Ding M AD - Vaccine Research and Development, Pfizer Inc, Pearl River, New York, USA. FAU - Suroju, Suresh AU - Suroju S AD - Vaccine Clinical Research and Development, Pfizer Ltd, Hurley, UK. FAU - Scott, Daniel A AU - Scott DA AD - Vaccine Clinical Research and Development, Pfizer Inc, Collegeville, PA, USA. FAU - Lockhart, Stephen P AU - Lockhart SP AD - Vaccine Clinical Research and Development, Pfizer Ltd, Hurley, UK. Electronic address: stephen.p.lockhart@pfizer.com. LA - eng SI - ClinicalTrials.gov/NCT03548337 PT - Clinical Trial, Phase IV PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20211014 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Heptavalent Pneumococcal Conjugate Vaccine) RN - 0 (Pneumococcal Vaccines) RN - 0 (Vaccines, Conjugate) SB - IM MH - Antibodies, Bacterial MH - Child MH - Double-Blind Method MH - Heptavalent Pneumococcal Conjugate Vaccine MH - Humans MH - Infant MH - *Pneumococcal Infections/prevention & control MH - Pneumococcal Vaccines/adverse effects MH - Vaccination MH - Vaccines, Conjugate/adverse effects OTO - NOTNLM OT - Children OT - Clinical trial OT - Infant OT - Multidose OT - Pneumococcal conjugate OT - Vaccine COIS- Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: WK, RC, MD, SS, DAS, and SPL are current employees of Pfizer Inc and may hold stock or stock options. PVR does not have any conflicts of interest to report. AS receives professional fees from the KEM Hospital Research Centre, Pune for her role as investigator in studies funded by Pfizer. EDAT- 2021/10/18 06:00 MHDA- 2022/01/27 06:00 CRDT- 2021/10/17 20:32 PHST- 2021/06/16 00:00 [received] PHST- 2021/09/07 00:00 [revised] PHST- 2021/09/09 00:00 [accepted] PHST- 2021/10/18 06:00 [pubmed] PHST- 2022/01/27 06:00 [medline] PHST- 2021/10/17 20:32 [entrez] AID - S0264-410X(21)01208-1 [pii] AID - 10.1016/j.vaccine.2021.09.029 [doi] PST - ppublish SO - Vaccine. 2021 Nov 5;39(46):6787-6795. doi: 10.1016/j.vaccine.2021.09.029. Epub 2021 Oct 14.