ArticleVaccines2026
Safety and Immunogenicity of SII's 10-Valent Pneumococcal Conjugate Vaccine (PCV10-SII) in Vietnamese Children Aged from 6 Weeks to 24 Months: An Open-Label, Single-Arm Bridging Study.
Article in Vaccines, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05140720 (Assess the Safety and Immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Assess the Safety and Immunogenicity of Serum Institute of India's PNEUMOSIL® [Pneumococcal Polysaccharide Conjugate Vaccine Adsorbed (10-Valent)] in Healthy Vietnamese Infants and Toddlers, 6 Weeks to 24 Months of Age
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
backgroundPneumococcal conjugate vaccines (PCVs) prevent severe disease in children, but high costs limit access. PCV10-SII (PNEUMOSIL), a 10-valent PCV prequalified by the World Health Organization (WHO) in 2019, offers a cost-effective alternative. This study assessed its safety and immunogenicity in Vietnamese children aged 6 weeks-24 months.
methodsAn open-label, single-arm study enrolled 304 children in three age groups: 6 weeks-6 months (n = 151), >6-12 months (n = 76), and >12-24 months (n = 77). Participants received two or three doses. Safety was evaluated through immediate reactions, adverse events (AEs), serious adverse events (SAEs), and withdrawals. Immunogenicity was measured 28 days after the final dose using serotype-specific IgG geometric mean concentrations (GMCs), opsonophagocytic activity (OPA) titers, and seroresponse rates. The trial was approved by the IRB of the National Ethics Council (code: No. 75/CN-HĐĐĐ on date 4 June 2021) and was registered with ClinicalTrials.gov, NCT05140720.
resultsOf 304 enrolled participants, 294 (96.7%) completed follow-up. No immediate adverse events or serious adverse events occurred. Unsolicited adverse events were reported in 17%, mainly respiratory, while serious adverse events occurred in 4%. Mild local/systemic reactions (e.g., injection site pain, crying) resolved without sequelae. Immunogenicity was strong, with GMCs 1.8-9.11 µg/mL, GMTs 277.8-22,342, and seroresponse rates >90% for 9 of 10 serotypes, serotype 6B demonstrated a slightly lower seroresponse rate of 88.6%.
conclusionsPCV10-SII demonstrated favorable safety and robust immunogenicity, supporting its inclusion in national immunization programs as an affordable option for pneumococcal disease prevention.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.