Retrospective review of administration of childhood primary vaccination schedule in an Irish tertiary neonatal intensive care unit

McCrossan, Patrick; McCafferty, C; Murphy, C.; Murphy, John F.

doi:10.1016/j.puhe.2015.05.005

Cited by 7 publications

(7 citation statements)

References 6 publications

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“…In this study a high percentage of premature infants mounted protective immune responses to antigens that have a well-defined correlate of protection or protocoldefined immune responses to vaccine antigens (Supplemental Table 3), as has been shown for another hexavalent combination vaccine. 6,7 Attaining a robust post infant series response to vaccination is particularly important for protection in the months prior to the toddler booster dose. The data show these post infant series responses to be robust and generally comparable with those of the full-term population.…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3][4][5] Despite these recommendations, the timeliness of vaccination in premature infants is often delayed, potentially due to parental or healthcare provider reluctance. 6,7 Preterm infants are at higher risk of adverse reactions, such as cardiopulmonary events, to vaccination. This is of particular concern in very preterm (born before 32 weeks gestation) and very low birth weight (<1500 g) infants and those with underlying cardio or respiratory abnormalities.…”

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Wilck

Stek

et al. 2020

Human Vaccines & Immunotherapeutics

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Background: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles generally similar to control vaccines. Here we evaluate safety and immunogenicity of DTaP-IPV-Hib-HepB vaccine in premature infants. Methods: Premature infants were identified using prior medical conditions terms "premature baby/ delivery" and/or "low birth weight baby". Immunogenicity and safety data were summarized across one Phase II and four Phase III randomized, active-comparator-controlled clinical trials (Protocol 004 in Canada [Control: PENTACEL™]; Protocols 005 and 006 in the US [Control: PENTACEL™]; and Protocols 007 and 008 in the EU [Control: INFANRIX™ hexa]) and one Phase III clinical trial in the UK (PRI01C); no formal statistical comparisons were performed. Results: Overall, 160 infants were considered premature (DTaP-IPV-Hib-HepB = 111 Control = 49). The incidence of adverse events (AEs) for DTaP-IPV-Hib-HepB was comparable between overall and premature populations for all AEs days 1-15 postvaccination (Overall = 96.3%; Premature = 97.3%;), solicited injection-site AEs days 1-5 postvaccination (Overall = 84.1%; Premature = 75.5%), and solicited systemic AEs days 1-5 postvaccination (Overall = 93.7%; Premature = 94.5%).A high percentage of premature infants mounted protective immune responses to antigens contained in DTaP-IPV-Hib-HepB vaccine. Response rates in preterm infants for all antigens (80-99%) were in a similar range to all infants (80-99%) for both DTaP-IPV-Hib-HepB and control vaccines. Conclusions: DTaP-IPV-Hib-HepB vaccine has a low incidence of AEs, an acceptable safety profile, and elicited satisfactory immune responses in premature infants comparable to the overall study population. These findings support vaccination with DTaP-IPV-Hib-HepB vaccine in healthy premature infants.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Wilck

Stek

et al. 2020

Human Vaccines & Immunotherapeutics

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“…[26][27][28][29][30][31][32] Targeted preterm vaccination intervention programs have reported favorable results in Ireland and Italy. 33,34 Delay of vaccination in preterm and LBW infants may most likely stem from inappropriate knowledge and perceptions of both parents and health-care providers regarding the safety and efficacy of timely routine childhood vaccinations. 35,36 Data validity of vaccination coverage rates is essential for planning and evaluation.…”

Section: Introductionmentioning

confidence: 99%

“…41 Previous studies evaluating vaccination coverage in preterm infants included samples that are often quite limited in size and data collected from parents' self-reporting, health-care provider records or incomplete databases. [26][27][28][29]33,34,44,45 National registry data are more appropriate to estimate vaccination coverage in relatively small groups that can be under-represented in population sample surveys.…”

Section: Introductionmentioning

confidence: 99%

Vaccination timeliness and completeness among preterm and low birthweight infants: a national cohort study

Bary-Weisberg

Stein‐Zamir

2020

Human Vaccines & Immunotherapeutics

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Vaccinating premature and low birthweight (LBW) infants according to chronological age has been found safe and effective. Although these infants are susceptible to infections, vaccinations are often delayed. We estimated vaccination coverage (VC) in preterm and LBW infants compared to term infants in a cohort study (2016 Israel birth cohort, n = 181,543) using the National Immunization Registry. Vaccinations included Hepatitis B, Diphtheria-Tetanus-acellular Pertussis-IPV-Haemophilus influenzae B, Oral Polio Bivalent, Rotavirus, Pneumococcal Conjugate, Measles-Mumps-Rubella-Varicella and Hepatitis A. Inclusion criteria: (1) born in Israel; (2) having a unique identifier (allowing data matching); and (3) surviving to 24 months. VC at 24 months and timeliness of vaccine doses were evaluated according to infants’ birthweight (BW) and gestational age (GA). Preterm infants (GA < 37 weeks) comprised 7.0% (n = 12,264); LBW infants (BW< 2500 g) were 7.7% (n = 13,950); BW was 1500–2499 g in 6.8%, 1000–1499 g in 0.6% and below 1000 g in 0.3%. Compared to normal birthweight (NBW) infants (BW≥2500 g), LBW infants showed delayed initiation of vaccinations. Odds ratio (OR) for delay: DTaP-IPV-Hib 1 OR = 1.26 [95%CI 1.19–1.33]; Rota 1, OR = 1.22 [95%CI 1.16–1.29]. Vaccination delay rates were higher among smaller new-borns (below 1000 g). At 24 months there was no significant difference regarding vaccination status. This national cohort VC analysis focused on preterm/LBW infants. Vaccinating preterm and LBW infants according to the recommended schedule induces protection against life-threatening infectious diseases. Vaccination initiation among LBW infants showed considerable delay. Health practitioners and parents should cooperate to improve timely vaccination initiation.

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“…In large studies the seroprotection rates for HBV were similar in very low birth weight (VLBW) and low birth weight (LBW) (93.7% vs. 94.9% respectively), However, seroprotection rates were reinforced (> 98%) by booster vaccination for all antigens except for HBs in VLBW children: only 88.7% of those had anti-HBs antibody concentrations > or = 10 mIU/mL, compared with 96.5% of LBW children (the difference was not statistically significant) [43]. In contrast, Omenaca et al did not observe no difference in the humoral response to HBV vaccination in preterm infants of lower GA and birth weight neither after primary cycle nor after a booster dose [46]. Only one study investigated the T cell-mediated response in preterm infants, showing comparable levels of memory T lymphocyte response for poliovirus antigens in full-term and preterm infants after hexavalent vaccination, but the latter demonstrate several nonspecific and poliovirus-specific functional T cell limitations.…”

Section: Resultsmentioning

confidence: 99%

Hexavalent vaccines in preterm infants: an update by Italian Society of Pediatric Allergy and Immunology jointly with the Italian Society of Neonatology

et al. 2019

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Hexavalent vaccines, protecting against six diseases (diphtheria, tetanus, pertussis [DTaP], poliovirus, hepatitis B virus [HBV], and Haemophilus influenzae type b [Hib], are routinely the standard of care in Europe. The use of combined vaccines allows the reduction of number of injections and side effects, the reduction of costs, and the increase in adherence of the family to the vaccination schedule both in terms of the number of doses and timing. The safety profile, efficacy and effectiveness of hexavalent vaccines have been extensively documented in infants and children born at term, and data are accumulating in preterm infants. Hexavalent vaccines are particularly important for preterm infants, who are at increased risk for severe forms of vaccine preventable diseases. However, immunization delay has been commonly reported in this age group. All the three hexavalent vaccines currently marketed in Italy can be used in preterm infants, and recent data confirm that hexavalent vaccines have a similar or lower incidence of adverse events in preterm compared to full-term infants; this is likely due to a weaker immune system response and reduced ability to induce an inflammatory response in preterm infants. Apnoea episodes are the adverse events that can occur in the most severe preterm infants and / or with history of respiratory distress. The risk of apnoea after vaccination seems to be related to a lower gestational age and a lower birth weight, supporting the hypothesis that it represents an unspecific response of the preterm infant to different procedures. High seroprotection rates have been reported in preterm infants vaccinated with hexavalent vaccine. However, a lower gestational age seems to be associated with lower antibody titres against some vaccine antigens (e.g. HBV, Hib, poliovirus serotype 1, and pertussis), regardless of the type of hexavalent vaccine used. Waiting for large effectiveness studies, hexavalent vaccines should be administered in preterm infants according to the same schedule recommended for infants born at term, considering their chronological age and providing an adequate monitoring for cardio-respiratory events in the 48–72 h after vaccination, especially for infants at risk of recurrence of apnoea.

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Retrospective review of administration of childhood primary vaccination schedule in an Irish tertiary neonatal intensive care unit

Cited by 7 publications

References 6 publications

Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Safety and immunogenicity of a fully-liquid DTaP-IPV-Hib-HepB vaccine (Vaxelis™) in premature infants

Vaccination timeliness and completeness among preterm and low birthweight infants: a national cohort study

Hexavalent vaccines in preterm infants: an update by Italian Society of Pediatric Allergy and Immunology jointly with the Italian Society of Neonatology

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