Synflorix (10-valent pneumococcal conjugate vaccine) / GSK - LARVOL DELTA

Pneumococcal carriage prevalence, serotype distribution, and vaccine coverage in Ethiopia 12 years after pneumococcal vaccine introduction. (PubMed, Vaccine) - "There is considerable residual circulation of vaccine serotypes in Ethiopia, particularly in rural areas and the east, and low vaccine coverage. Pneumococcal epidemiology varies by geographical region and urban/rural setting, implying an unequal burden of pneumococcal disease across the country 12 years post-PCV introduction."

Journal • Infectious Disease • Pneumococcal Infections

Cost-effectiveness of a 13-valent pneumococcal conjugate vaccine compared with currently available pneumococcal conjugate vaccines in Indian children. (PubMed, IJID Reg) - "This yielded incremental cost-effectiveness ratios (ICERs) for PCV13-PFE vs PCV10-SII and PCV10-GSK of INR 18,142 and INR 304,234 per QALY, respectively, both below the willingness-to-pay threshold of INR 590,949. PCV13-PFE was cost-saving compared to PCV14-BE. From the private sector perspective, vaccinating children in India with PCV13-PFE could prevent more PD cases, save more PD-associated medical costs, and be more cost-effective than other locally available PCV options."

HEOR • Journal • Infectious Disease • Pneumococcal Infections

The impact of 10-valent pneumococcal conjugate vaccine on the incidence of admissions to hospital with hypoxaemic and non-hypoxaemic pneumonia in Kenyan children. (PubMed, PLOS Glob Public Health) - "We examined the impact of 10-valent PCV (PCV10, Synflorix) on hypoxaemic pneumonia hospital admissions using data from an existing PCV impact study of clinical and radiographic pneumonia. Despite the consistent pneumonia surveillance and robust ITS analysis which accounted for pre-PCV10 secular trend and seasonality, the apparent association with hypoxaemic pneumonia is likely due to unmeasured time-varying confounders around the time of vaccine introduction, such as the epidemiology of other respiratory pathogens. This study highlights limitations in the analysis and interpretation of observational data in vaccine impact studies against pneumonia."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Genomic analysis of invasive and non-invasive disease-causing Streptococcus pneumoniae isolated from children between 2014 and 2023 in Suzhou, China. (PubMed, Microb Genom) - "We found that the majority (64.8%, n=271) of samples represented serotypes that are covered by the GSK 10-valent PCV (PCV10) formulation and that even more were covered by the SII PCV10 formulation (89.2%, n=373)...In summary, the PCV13 vaccine could potentially cover over 90% of invasive and non-invasive S. pneumoniae isolates in Suzhou, China. Therefore, increasing the uptake of PCVs by including PCV13 in the NIP would lead to significant benefits for child health."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

Economic Evaluation of PHID-CV versus PCV10-SII Compared with no Vaccination in the Philippines. (PubMed, Infect Dis Ther) - "Both vaccination strategies are superior to no vaccination, producing more health benefits at lower costs. QALYs gained are higher with PHiD-CV but at higher direct costs. Results are most sensitive to assumptions about PCV10-SII vaccine price."

HEOR • Journal • CNS Disorders • Infectious Disease • Otorhinolaryngology • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Indirect Comparison of PCV20 Immunogenicity with PCV10 in Pediatric 3 + 1 and 2 + 1 Schedules. (PubMed, Infect Dis Ther) - "The comparable immunogenicity of PCV20 versus PCV10 in 2 + 1 and 3 + 1 schedules suggests that PCV20 will have similar effectiveness for the ten serotypes included in both vaccines, including for direct protection during infancy and toddler age, while also expanding serotype coverage. Effectiveness for PCV20 needs to be confirmed in post-marketing studies."

Journal • Infectious Disease • Pediatrics • Pneumococcal Infections • Pneumonia

Investigating two decades of Streptococcus pneumoniae bacteraemia in the Gelderland area, the Netherlands, using whole-genome sequencing. (PubMed, Microb Genom) - "In the Netherlands, the 7-valent pneumococcal conjugate vaccine (PCV) was introduced to the childhood immunization programme in 2006 and replaced by the 10-valent PCV (PCV10, GSK) in 2011...Comparison to global collections of GPSC10, GPSC1 and GPSC6 isolates favored the likelihood of separate introductions of penicillin-resistant isolates rather than cloncal expansion. Genomic surveillance of pneumococcal bacteraemia in this unbiased population sample in the Netherlands supports the use of higher valency PCVs, such as PCV20, especially in adults, to prevent future bacteraemia cases caused by Streptococcus pneumoniae in the Gelderland area, the Netherlands, while maintaining a low prevalence of AMR in the pneumococcal population."

Journal • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia

Unprecedented cases of pneumococcal associated haemolytic uraemic syndrome in New Zealand (IPNA 2025) - "During this period New Zealand’s national immunisation infant schedule included pneumococcal conjugate vaccine (PCV) 10 (Synflorix)...There were two deaths and two cases with neurological manifestations of HUS managed with eculizumab...Results . Conclusions ."

Clinical • Atypical Hemolytic Uremic Syndrome • Chronic Kidney Disease • CNS Disorders • Infectious Disease • Nephrology • Pediatrics • Pneumococcal Infections • Pneumonia • Renal Disease • Respiratory Diseases

Serotype distribution of remaining invasive pneumococcal disease after extensive use of ten-valent and 13-valent pneumococcal conjugate vaccines (the PSERENADE project): a global surveillance analysis. (PubMed, Lancet Infect Dis) - "The proportion of IPD due to serotypes included in PCVs in use was low in mature PCV10 and PCV13 settings. Serotype distribution differed between PCV10 and PCV13 sites and age groups. Higher-valency PCVs target most remaining IPD and are expected to extend impact."

Journal • Infectious Disease • Pneumococcal Infections

Penicillin Non-susceptibility in Pneumococcal Carriage Isolates From Patients With Acute Respiratory Illness In Kenya, 2017 - 2020 (ASTMH 2024) - "We observed high penicillin non-susceptibility in pneumococcal carriage isolates, particularly among vaccine serotypes, in the context of a mature PCV program. The recently introduced PCV10 SII that contains 6A may be useful in combating AMR."

Clinical • CNS Disorders • Infectious Disease • Pneumococcal Infections • Respiratory Diseases

FPCV: The Effect of Fractional Doses of Pneumococcal Conjugate Vaccines on Immunogenicity and Carriage in Kenyan Infants (clinicaltrials.gov) - P4 | N=2100 | Completed | Sponsor: London School of Hygiene and Tropical Medicine | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumococcal Infections • Pneumonia

Cost-Effectiveness of a 13-Valent Pneumococcal Conjugate Vaccine Compared With Currently Available Pneumococcal Conjugate Vaccines in Indian Children (ISPOR-EU 2024) - "From the private sector perspective, vaccinating children with PCV13 could prevent more PD cases, save more PD associated medical costs, and was more cost-effective compared to other alternative vaccination choices."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Pneumococcal Infections

Fractional Doses of Pneumococcal Conjugate Vaccine - A Noninferiority Trial. (PubMed, N Engl J Med) - P4 | "In a three-dose schedule (two primary doses and a booster), 40% doses of PCV13 were noninferior to full doses for all included serotypes. Lower doses of PCV13 and PCV10 did not meet the criteria for noninferiority. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03489018; Pan African Clinical Trial Registry number, PACTR202104717648755.)."

Head-to-Head • Journal • Infectious Disease • Pneumococcal Infections

Immunogenicity and seroefficacy of pneumococcal conjugate vaccines: a systematic review and network meta-analysis. (PubMed, Health Technol Assess) - "34. See the NIHR Funding and Awards website for further award information."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Long-term impact of 10-valent pneumococcal conjugate vaccine in Kenya: Nasopharyngeal carriage among children in a rural and an urban site six years after introduction. (PubMed, Vaccine) - "Six years post-PCV10-GSK introduction, the prevalence of pneumococcal carriage among children has decreased, and the impact of PCV10-GSK on vaccine-type carriage has plateaued. Kenya recently changed from PCV10-GSK to Pneumosil™ (Serum Institute of India), a 10-valent PCV that includes serotypes 6A and 19A; these data provide historical context for interpreting changes in vaccine-type carriage following the PCV formulation switch."

Journal • Infectious Disease • Pneumococcal Infections • Pneumonia

PCV1+1_FU: Persistence of Immunogenicity Following Reduced PCV Dosing Schedules in South African Children (clinicaltrials.gov) - P=N/A | N=600 | Completed | Sponsor: University of Witwatersrand, South Africa | Recruiting ➔ Completed

Trial completion • CNS Disorders • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Hearing loss in Australian First Nations children at 6-monthly assessments from age 12 to 36 months: Secondary outcomes from randomised controlled trials of novel pneumococcal conjugate vaccine schedules. (PubMed, PLoS Med) - P4 | "In this study, we observed a high prevalence and persistence of moderate (disabling) hearing loss throughout early childhood. We found a lower prevalence of moderate hearing loss and correspondingly higher prevalence of no hearing loss in the +P group, which may have substantial benefits for high-risk children, their families, and society, but warrant further investigation."

Clinical • Journal • Developmental Disorders • Infectious Disease • Influenza • Otorhinolaryngology • Pneumococcal Infections • Respiratory Diseases

COST-EFFECTIVENESS OF A 13-VALENT PEDIATRIC PNEUMOCOCCAL CONJUGATE VACCINE COMPARED WITH TWO 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINES IN INDIA (ESPID 2024) - "Considering the estimated net costs and life-years (LY) or quality-adjusted life-years(QALY) saved, the incremental cost effectiveness ratio (ICER) of PCV13 vs. PCV10-SII and PCV10-GSK were ₹153,060 and ₹ 292,950 per QALY, and ICERs per LY or per QALY were all below the 3 times of 2023 GDP per capita in India (₹ 196,983)(Table 1). Conclusions/Learning Points Overall, vaccination with PCV13 in infants could prevent more pneumococcal disease cases and deaths than PCV10-GSK and PCV-SII in India private sector and were estimated to be more cost effective than lower-valent PCVs."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Pediatrics • Pneumococcal Infections

Evaluation of PCV Schedules in a Naive Population in Vietnam (clinicaltrials.gov) - P4 | N=18652 | Completed | Sponsor: Nagasaki University | Recruiting ➔ Completed | N=45360 ➔ 18652 | Trial completion date: Mar 2023 ➔ Dec 2023

Enrollment change • Trial completion • Trial completion date • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

EFFECT OF SWITCHING FROM 2P+1 TO 1P+1 IN SETTINGS WITHOUT ELIMINATION OF VT CIRCULATION, A MODELING STUDY (ISPPD 2024) - "Methods We used a transmission model and data from a cRCT in Nha Trang, Vietnam to estimate the vaccine efficacy (VE) and duration of vaccine protection against VT carriage for doses administered under 2p+1 and 1p+1 schedules using Synflorix...Reductions are highest in high-transmission settings with high remaining VT carriage despite high vaccination coverage. Conclusions A switch to a 1p+1 schedule may result in moderate increases in infant IPD in most settings where VT have not been eliminated."

Infectious Disease • Pneumococcal Infections

VACCINE-SEROTYPE CARRIAGE AT 18 MONTHS OF AGE, AFTER FULL OR FRACTIONAL DOSES OF PNEUMOCOCCAL CONJUGATE VACCINES IN KENYAN INFANTS: A RANDOMISED CONTROLLED TRIAL (ISPPD 2024) - "We aimed to assess whether immunogenicity and reduction of vaccine serotype (VT) carriage was non-inferior after fractional doses of PCV10 (GSK) or PCV13, when compared to full doses...Conclusions A 3-dose schedule of 40%-PCV13 met the non-inferiority criteria at both timepoints and demonstrated similar effects on VT carriage at 18 months of age as the full dose schedule. A 3-dose schedule of 40%-PCV13 would cost 3.7 USD and represents the most cost-effective PCV schedule currently available."

Clinical • Infectious Disease • Pneumococcal Infections

INDIRECT EFFECTS OF THE 10-VALENT PNEUMOCOCCAL CONJUGATE VACCINE ON INVASIVE PNEUMOCOCCAL DISEASE AND PNEUMONIA IN INFANTS YOUNGER THAN 10 WEEKS OF AGE IN SOUTHERN MOZAMBIQUE. (ISPPD 2024) - "We observed 3 and 0 deaths due to IPD and 29 and 9 deaths among SSP from the pre- to post-PCV period. Conclusions PCV10 introduction led to substantial declines in the incidence of IPD and SSP in infants aged <10 weeks in Mozambique, suggesting indirect protection."

Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

THE IMPACT OF PCV10 ON PNEUMOCOCCAL POPULATION STRUCTURE IN KILIFI, KENYA: A WHOLE GENOME SEQUENCING ANALYSIS (ISPPD 2024) - "The frequency of resistant genes to cotrimoxazole, doxycycline, penicillin and tetracycline declined after PCV10 introduction. Conclusions Serotypes and GPSCs expansion after PCV10 introduction a potential concern as it poses a challenge to effective control of invasive pneumococcal transmission. Monitoring for vaccine uptake and an in-depth genomic analysis of these isolates would provide further insights."

Clinical • Whole genome sequencing • Infectious Disease • Pneumococcal Infections

DECLINES IN VACCINE-TYPE IPD BY DOSING SCHEDULE IN PCV10 (SYNFLORIX) AND PCV13 (PREVNAR13) CHILDHOOD IMMUNIZATION PROGRAMS AMONG CHILDREN AND OLDER ADULTS GLOBALLY: THE PSERENADE PROJECT (ISPPD 2024) - "Conclusions Vaccine-type IPD declines did not seem meaningfully different between schedules, but data from 3+0 sites were too sparse to fully assess booster versus no booster. Factors correlated with schedule choice may have confounded results."

Clinical • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases

HEARING LOSS AND OTITIS MEDIA AT 6-MONTHLY ASSESSMENTS OF AUSTRALIAN FIRST NATIONS CHILDREN BETWEEN AGES 12 TO 36 MONTHS: THE PREVIX_BOOST AND VOICES TRIAL. (ISPPD 2024) - "Methods In two sequential parallel, open-label, randomised controlled trials, eligible infants were first allocated 1:1:1 at age 28-38 days to standard or mixed PCV primary schedules, then at age 12 months to a booster dose (1:1) of PCV13 (Prevenar13®, +P) or PHiD-CV10 (Synflorix®, +S)...Conclusions Our PREVIX_VOICES study provides first evidence of the high prevalence and persistence of mild or moderate hearing loss from age 12 (75%) to 36 (58%) months. A transient reduction in hearing loss post PCV13 booster dose warrants further investigation."

Clinical • Infectious Disease • Otorhinolaryngology • Pneumococcal Infections