Immunogenicity, safety and tolerability of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months post-natally to pre- and full-term infants

Esposito, Susanna; Pugni, Lorenza; Bosis, Samantha; Proto, A; Cesati, Laura; Bianchi, Ciro; Cimino, C; Mosca, Fabio; Principi, Nicola

doi:10.1016/j.vaccine.2004.09.029

Cited by 90 publications

(41 citation statements)

References 23 publications

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“…However, the Municipal Council in Kielce decided to apply the 2+1 scheme, as it was not only cheaper, which was a particularly important factor in this case, but also, as evidenced in numerous studies [13,15,16,28], was as efficient in a mass vaccination pattern as the original 3+1 scheme. The scheme was, thus, approved for population vaccination also in the registration dossier.…”

Section: Discussionmentioning

confidence: 99%

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Significant decline in pneumonia admission rate after the introduction of routine 2+1 dose schedule heptavalent pneumococcal conjugate vaccine (PCV7) in children under 5 years of age in Kielce, Poland

Patrzałek¹,

Albrecht

Sobczyński

2010

Eur J Clin Microbiol Infect Dis

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International audienceThis study was performed to estimate the effect of heptavalent pneumococcal conjugate vaccine (PCV7) on the pneumonia admission rate in children younger than 5 years of age, after the introduction of routine 2+1 dose schedule immunization. We compared the pneumonia admission rate (number of cases per 1,000 population) 2 years before and 2 years after the introduction of PCV7 in 2006. Only children with radiologically confirmed pneumonia were analyzed. The vaccination rate in the analyzed periods was around 99%. In the period preceding the implementation of PCV7, the average pneumonia admission rate was 41.48/1,000 and 6.15/1,000 for 1-year-old and 2-4-year-old children, respectively. Statistical analysis showed a significant fall in this rate in two consecutive years after PCV7 implementation ( < 0.0000001 for 1-year-old and = 0.011 for 2-4-year-old children, respectively). In the first year of vaccination, the admission number decreased in these two groups by about 65 and 23%, respectively. In the second year, only a few percent fall in the admission rate was noted. In children younger than 2 years of age, the age group targeted for vaccination, pneumonia-related healthcare utilization declined substantially following PCV7 introduction. These results suggest that PCV7 may play an important role in reducing the burden of pneumonia in Poland

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Section: Discussionmentioning

confidence: 99%

“…For logistic reasons, we start PCV7 vaccination in the third or fourth month of life, which is somewhat later than that generally recommended. Nonetheless, according to some data [13,15,16], this delay may render a better immunological response .…”

mentioning

confidence: 99%

Significant decline in pneumonia admission rate after the introduction of routine 2+1 dose schedule heptavalent pneumococcal conjugate vaccine (PCV7) in children under 5 years of age in Kielce, Poland

Patrzałek¹,

Albrecht

Sobczyński

2010

Eur J Clin Microbiol Infect Dis

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“…4 Studies evaluating immune responses of preterm infants receiving pneumococcal vaccinations are scarce, and methodologic differences limit interpretation of the findings. 2,[5][6][7] However, the data suggest that gestational age (GA) and vaccination timing (eg, allowing for immune maturation) may affect the ability of preterm infants to respond adequately to immunization. To the best of our knowledge, to date, no study has evaluated the 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants.…”

Section: What This Study Addsmentioning

confidence: 99%

13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants

et al. 2015

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OBJECTIVES: This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.METHODS: This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheriatetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).RESULTS: Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration $0.35 mg/mL for all serotypes: .85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and .97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups.CONCLUSIONS: Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.

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“…A change in the number of doses administered only affects the investment costs. It is assumed that this a scenario involves the same efficacy as the base-case analysis [15]. Low discount rate effects A scenario applying a 1.5% instead of a 4% discount rate for health effects.…”

Section: -Dosesmentioning

confidence: 99%

“…Additionally, ongoing research has provided important new data. For example, recent evidence indicates that with less than four doses of the vaccine a sufficient level of immunological protection might also be attained [15]. Also, protective effects of infant vaccination on unvaccinated age groups (herd protection), have been reported by Whitney et al [16].…”

Section: Introductionmentioning

confidence: 96%

Enhanced decision support for policy makers using a web interface to health-economic models—Illustrated with a cost-effectiveness analysis of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine in the Netherlands

Hubben

Bos

Glynn³

et al. 2007

Vaccine

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Enhanced decision support for policy makers using a web interface to health-economic models -Illustrated with a cost-effectiveness analysis of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine in the Netherlands Hubben, G.A.A.; Bos, J.M.; Glynn, D.M.; op 't Ende, Anna; van Alphen, L.; Postma, Maarten Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. AbstractWe have developed a web-based user-interface (web interface) to enhance the usefulness of health-economic evaluations to support decision making (http://pcv.healtheconomics.nl). It allows the user to interact with a health-economic model to evaluate predefined and customized scenarios and perform sensitivity analysis. To explore its usefulness, it was applied to an evaluation of cost-effectiveness of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine (PCV7), that was used to support a policy decision on the inclusion of PCV7 in the national vaccination program (NVP) of the Netherlands. We used a decision-tree analytic model to project the impact of infant vaccination with four doses of PCV7 on an annual cohort of infants born in the Netherlands. The base-case analysis includes the beneficial effects on unvaccinated individuals (herd protection). Additional scenarios varying the number of doses, discount rate for effects and the number of serotypes in the vaccine were evaluated and can be analysed on the web. Our model projects a base-case incremental cost-effectiveness ratio (iCER) of D 14,000 (95% uncertainty interval (UI): 9,800-20,200) per quality adjusted life year (QALY) or D 15,600 (95% UI: 11,100-23,900) per life year gained (LYG).

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Immunogenicity, safety and tolerability of heptavalent pneumococcal conjugate vaccine administered at 3, 5 and 11 months post-natally to pre- and full-term infants

Cited by 90 publications

References 23 publications

Significant decline in pneumonia admission rate after the introduction of routine 2+1 dose schedule heptavalent pneumococcal conjugate vaccine (PCV7) in children under 5 years of age in Kielce, Poland

Significant decline in pneumonia admission rate after the introduction of routine 2+1 dose schedule heptavalent pneumococcal conjugate vaccine (PCV7) in children under 5 years of age in Kielce, Poland

13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Preterm Versus Term Infants

Enhanced decision support for policy makers using a web interface to health-economic models—Illustrated with a cost-effectiveness analysis of nation-wide infant vaccination with the 7-valent pneumococcal conjugate vaccine in the Netherlands

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