Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar®) administered in previously unvaccinated Spanish children aged 24 to 36 months

Fernández, Javier de Arístegui; Arregui, Begoña Cos; Carril, Ana Zurimendi; Esteban, Ma Victoria Alday; Ruiz, Javier Alzua; Jausoro, Emma De la Fuente; Pedro, Inmaculada Maturana San; Michelena, Ma José López; Carballo, C; Sanchez, M.; Therón, Inmaculada Abad; Cimino, C; Fletcher, Mark A.; Domínguez, Ana Pérez

doi:10.1016/j.vaccine.2004.10.024

Cited by 21 publications

(5 citation statements)

References 14 publications

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“…In the three studies of one or two catch-up doses administered to children aged above 2 years, the incidence of pain (overall per dose) was in the range 61-69%. The observation of more frequent pain in older children is in line with reports following PHiD-CV and 7vCRM booster vaccination in the second year of life [10] and following 7vCRM vaccination in children aged above 2 years [18]. Catch-up vaccination in older children was otherwise generally well tolerated.…”

Section: Safety In Other Catch-up Vaccination Groupssupporting

confidence: 88%

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Silfverdal

Coremans

François

et al. 2016

Expert Review of Vaccines

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Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.

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Section: Safety In Other Catch-up Vaccination Groupssupporting

confidence: 88%

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Silfverdal

Coremans

François

et al. 2016

Expert Review of Vaccines

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“…Antibody GMCs following PHiD-CV priming in our study were lower (non-overlapping 95% CIs) for 4 serotypes and in the same range or higher for the remaining 5 serotypes compared to a previous study with a 9-valent pneumococcal CRM 197 -conjugate post-booster antibody concentrations and OPA GMTs exceeded those measured following 2-dose catch-up immunization and further clinical data will be required to clarify the benefit of and/ or the need for a booster dose after 2-dose PHiD-CV catch-up immunization in the second year of life. As with other pneumococcal conjugate vaccines, [23][24][25] until the need for a booster dose is …”

Section: ©2 0 1 1 L a N D E S B I O S C I E N C E D O N O T D I S Tmentioning

confidence: 99%

Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children

Lagos¹,

Muñoz²,

Levine³

et al. 2011

Human Vaccines

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“…However, generally influenza vaccines appeared well tolerated and safe in children (20), which compares favourably with the safety profile of influenza vaccine in this study. A previous study assessing the safety of the heptavalent pneumococcal conjugate vaccine in children aged 24–36 months, reported local reactions (erythema, induration or tenderness) in 32–40% within 72 h and fever (≥38°C) in about 9% within 7 days post‐immunization (21). In our study, erythema was reported with similar frequency, but tenderness and fever was reported more often in the IV + PV group of our study.…”

Section: Discussionmentioning

confidence: 99%

Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children: randomized double‐blind controlled trial

Jansen

Sanders

Smulders

et al. 2008

Pediatric Allergy Immunology

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In a randomized double-blind controlled trial, the safety was assessed of simultaneous administration of influenza and pneumococcal conjugate vaccines in children with previous physician-diagnosed respiratory tract infections. In total, 579 children aged 18-72 months were assigned to receive simultaneous intramuscular influenza and pneumococcal heptavalent conjugate vaccinations (IV + PV), influenza and placebo vaccinations (IV + plac) or control hepatitis B and placebo vaccinations (HepB + plac) in separate extremities. Local and systemic adverse events were recorded in parental diaries for 7 days after vaccination. No immediate adverse reactions were recorded. In most children local adverse reactions disappeared 2 days after vaccination. Local and systemic reactions were more prevalent (30% and 10% more) in the IV + PV group compared with the IV + plac and HepB + plac group. These results are important for designing future vaccination schedules.

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Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar®) administered in previously unvaccinated Spanish children aged 24 to 36 months

Cited by 21 publications

References 14 publications

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children

Adverse reactions to simultaneous influenza and pneumococcal conjugate vaccinations in children: randomized double‐blind controlled trial

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