ABSTRACT
Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023 included recommendations for co-administration of pediatric vaccines, including the four-component vaccine for meningococcus B (4CMenB), pneumococcal conjugate vaccine (PCV), hexavalent vaccines, and oral rotavirus vaccines. Safety is a major concern when considering vaccine co-administration; therefore, a literature review of the available evidence on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines was performed. Of 763 publications screened, two studies were reviewed that reported safety data on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines in infants aged 0–24 months. Overall, these studies supported that there were no significant safety signals when co-administering 4CMenB with PCV, hexavalent/pentavalent, and rotavirus vaccines, compared with individual vaccination. This review provides key insights for healthcare professionals on the tolerability of co-administering 4CMenB with routine vaccines.
Introduction
Vaccine co-administration describes the process in which two or more vaccines are administered during the same appointment or session. Vaccine co-administration has been identified as a useful strategy to improve vaccine coverage rates and compliance with national immunization programs (NIPs) by reducing the number of vaccination sessions needed,Citation1,Citation2 thereby reducing the resource utilization of vaccination services in addition to potential stress imposed on children and parents.Citation2–4 Furthermore, co-administration may also reduce the number of missed opportunities for vaccination, a key contributor to incomplete immunization.Citation2,Citation5
The burden of infectious diseases such as invasive meningococcal disease (IMD) and rotavirus (RV) disease, which mainly affect infants and toddlers within 2 y of age, has substantially reduced following the introduction of respective vaccines.Citation6,Citation7 In Italy, recent studies have indicated that earlier immunization of infants with the four component vaccine for meningococcus B (4CMenB) and RV vaccines may provide a greater level of protection against their respective diseases.Citation8–10 In particular, initiating the 4CMenB vaccination schedule at 2 months versus 7 months of age led to more than a 2-fold decrease in the incidence of IMD when comparing discrete data from two different regions,Citation8 consistent with a peak in IMD reported in infants aged 4–8 months old.Citation11 Therefore, optimizing immunization calendars is important to ensure maximum coverage and protection against disease.
In Italy, the immunization schedule for infants aged less than 24 months includes both mandatory vaccines (e.g., hexavalent vaccines), which are compulsory by national law, and recommended vaccines (e.g., 4CMenB, RV and pneumococcus vaccines). This can lead to variable rates of adherence between vaccines. According to data from the Italian Ministry of Health, coverage rates of mandatory vaccines, are generally higher than for recommended vaccines ().Citation12 This is potentially due to crowded immunization schedules,Citation13 particularly among infants less than 24 months old, which could impact adherence or delay scheduled vaccination timings. It is also interesting to note that pneumococcus vaccination, which is historically co-administered with hexavalent vaccines, reached high coverage rates, similar to those of mandatory vaccines, despite being recommended and not mandatory (). The National Vaccine Prevention Plan (NVPP) in Italy was recently updated in 2023 (version: 2023– 2025),Citation14 recommending that, whenever possible, vaccines should be offered in co-administration, including pediatric vaccines. Although the impact on immunogenicity must be considered when co-administering vaccines, the combination of pediatric vaccines typically has no significant impact on immunogenicity profiles, and is seen as common practice in many countries.Citation2 A survey conducted in Calabria, Italy, in 2022, reported that the majority of healthcare professionals (HCPs) supported vaccine co-administration as an effective strategy to improve immunization calendars, as it can provide a range of benefits to healthcare systems and patients.Citation15 However, concerns were raised regarding the lack of readily available information on the safety of concomitant administration of multiple vaccines in pediatric populations, which could limit the implementation of coadministration strategies.Citation15 In particular, HCPs noted that limited safety data on co-administration of vaccines was often perceived as a key barrier, limiting its use in clinical practice.Citation15 Similar findings were also reported in 2022, in a survey carried out among Public Health Nurses.Citation16 An earlier study among HCPs had also reported hesitancy toward 4CMenB co-administration, owing to a lack of explicit guidance and information on the co-administration of pediatric vaccines.Citation17
Given the importance of available information on the safety of vaccine co-administration, highlighted in surveys of HCPs,Citation15,Citation16 the objective of this narrative review was to assess the available literature reporting on the safety profile of co-administering 4CMenB with three vaccines (pneumococcal conjugate vaccine [PCV], hexavalent, and RV vaccines) at the same visit in pediatric populations aged 0–24 months.
Methods
Search strategy
A targeted literature search was performed in July 2023 to identify the available evidence on the co-administration of 4CMenB with PCV, hexavalent vaccines (diphtheria, tetanus, acellular pertussis [DTaP], Haemophilus influenzae type b [Hib], poliovirus and hepatitis B [DTaP-Hib-IPV-HepB]), and oral RV vaccines, in infants aged 0–24 months.
The search strategy main string comprised: (4CMenB OR Bexsero OR pneumococcal vaccine OR rotavirus vaccine OR hexavalent vaccines) AND (co-administ* OR concomitant* administ* OR simultan* administ* OR coadminist*) AND (safety drug-related side effects OR adverse reactions OR adverse effects OR complications OR safety OR tolerability).
Articles that specifically reported data in infants aged 0–24 months related to the incidence of adverse events following immunization (AEFIs) and other safety signals for 4CMenB vaccination, co-administered with PCV, DTaP-Hib-IPV-HepB, and RV vaccines, were included. Studies that reported safety data for pentavalent vaccines (DTaP-IPV-Hib) co-administered with 4CMenB were also included, due to the similarity in safety profiles compared to hexavalent vaccines.Citation18 No geographical or language restrictions were applied in the literature search.
Articles that did not report safety data for 4CMenB coadministration with all specified vaccines of interest (PCV, DTaP-Hib-IPV-HepB [or DTaP-IPV-Hib], and RV) were excluded. To focus the literature search on recent findings, articles published before 2018 were excluded, since the United Kingdom (UK) was the only country to have implemented a 4CMenB infant vaccination program prior to 2018.
Results
Overview of included studies
A total of 763 articles in PubMed and 599 in Embase were identified. After screening, 167 articles (PubMed: n = 86; Embase: n = 81) published since 2018 were considered for eligibility.
Of the 167 articles considered, two studies included data for all primary vaccines included in the search strategy;Citation19,Citation20 relevant findings from these studies are presented in the results. The remaining 165 articles were excluded from this section, owing to the strict nature of the inclusion criteria, in that co-administration data must be present for all three targeted vaccines in this review. Insights from this selection of studies that reported on the safety of 4CMenB co-administration, but reported on similar vaccine pairings with 4CMenB, are considered in the discussion.
Of the two included studies, both had originated from the UK. Summaries of the study designs and key outcomes are shown in .
Vaccine co-administration safety outcomes
The safety of 4CMenB has been evaluated across 17 studies, which included 10 randomized controlled trials whereby participants received at least one dose of 4CMenB.Citation21 Among infants and children, the most commonly reported adverse events associated with 4CMenB administration include fever (≥38°C), irritability and tenderness and erythema at the injection site.Citation21
In this targeted literature review, one article identified was a large prospective surveillance study in the UK, which evaluated approximately 1.29 million infants aged 2–18 months.Citation20 In total, the study population had received an estimated 3 million doses of 4CMenB co-administered with two injectable vaccines (DTaP-IPV-Hib and PCV) plus the oral RV vaccine, or with three injectable vaccines (Hib-meningococcal C [MenC], PCV, and measles, mumps, and rubella [MMR]) during routine vaccination campaigns ().Citation20 No safety issues were reported when comparing concomitant vaccine administration with the same vaccines administered without 4CMenB.Citation20 The most common AEFIs reported were local reactions (41%) and fever (40%). The introduction of 4CMenB co-administration had no reported impact on compliance with other routine vaccinations.Citation20
The second article by Bauwens et al.Citation19 assessed AEFIs from 5,993,290 vaccine doses administered to 958,591 infants, of which 46,532 doses of 4CMenB were co-administered with two injectable vaccines (DTaP-IPV-Hib and PCV [n = 42,154]; or DTaP-IPV-Hib and MenC [n = 2,748]) or three injectable vaccines (MenC, MMR, and PCV [n = 1,630]). Similar to the UK prospective surveillance study,Citation20 there were no significant changes in the rate of AEFIs (including fever) in infants who received 4CMenB co-administrations when compared to the same vaccines administered without 4CMenB ().Citation19
Discussion
This narrative review aimed to summarize available evidence on the rates of AEFIs following co-administration of 4CMenB with two injectable vaccines (PCV and hexavalent/pentavalent vaccines) and one oral vaccine (RV) in a single session.
Overall, there was a lack of studies evaluating the co-administration of 4CMenB with PCV and hexavalent/pentavalent and RV vaccines. Despite this, the limited evidence available suggests that co-administration of 4CMenB with PCV, hexavalent or pentavalent, and RV vaccines does not increase the risk or severity of AEFIs compared with individual administration.Citation19,Citation20,Citation22 In support of this, a review of the 4CmenB safety profile when co-administered with routine childhood and adulthood vaccines reported no significant safety concerns.Citation23 Relevant to this article, the authors also concluded no safety concerns with DtaP-Hib-IPV-HepB, PCV7 or PCV13, and RV vaccines co-administered with 4CmenB.Citation23
The safety data reported here were also consistent with the clinical development program of 4CMenB, which included phase 2 and phase 3 trials in infants who received 4CMenB co-administered with a hexavalent vaccine and PCV.Citation24–26 In these trials, 4CMenB was well tolerated when administered alone or concomitantly with other injectable vaccines, and no differences in immunological responses were observed.Citation24 A subset of participants also concomitantly received an oral RV vaccine with 4CMenB and other routine vaccines. Rates of fever in the group receiving concomitant RV vaccination were similar to those who did not receive RV vaccination (2.2% [3/135] vs 2.6% [37/1,435]).Citation24 Overall rates of systemic reaction were 80.5% in the group who received concomitant RV vaccination versus 75.3% in the group not receiving concomitant RV vaccination.Citation24 However, given that only two studies were identified in this targeted review, further evaluation of the safety of simultaneous 4CMenB co-administration with PCV and hexavalent/pentavalent and RV vaccines would be beneficial.
Real-world, historic data from the UK further support the strategy of co-administering 4CMenB with PCV, DTaP-IPV-Hib, and the oral RV vaccine, as no notable reductions in vaccine efficacy, and no impact on the overall safety and tolerability of these vaccines were observed when co-administered in the NIP.Citation20,Citation27 However, the UK has since updated the PCV immunization program so that 4CMenB is no longer co-administered with PCV, DTaP-IPV-Hib, and the oral RV vaccine.Citation28
Another UK-based trial, excluded from the search results because of a lack of RV vaccination data and a non-concomitant control, investigated differences in immunogenicity and reactogenicity of 4CMenB co-administration with two licensed hexavalent vaccines, Hex-V (MCM Vaccines, Leiden, Netherlands) and Hex-IH (GlaxoSmithKline, Rixensart, Belgium).Citation29 Comparable rates of AEFIs were reported between Hex-IH or Hex-V co-administration with 4CMenB, with only one serious adverse event (fever) considered related to vaccination; the participant developed a fever, tachycardia, and tachypnea following vaccination.Citation29 However, it was not stated whether prophylactic paracetamol following MenB vaccination was enacted in this study, as recommended in the UK.Citation30 The immunogenicity of 4CMenB co-administration with hexavalent vaccines is not expected to be impaired, since high levels of Haemophilus influenza type b polysaccharide antigen, anti-polyribosylribitol phosphate immunoglobulin G, were observed post-vaccination.Citation29 However, there was a lack of data on the immunogenicity profiles of 4CMenB and the co-administered vaccines in the articles examined in this review.
An additional study, evaluating the occurrence of AEFIs related to 4CMenB co-administration with routine vaccines in three European randomized controlled trials (NCT00657709, NCT00847145, NCT00721396), was also not included in the search results due to a lack of data on RV vaccination.Citation22 However, this study provides further insight on the safety of 4CMenB co-administration. Of 5,026 healthy infants aged 2–15 months, the incidence of fever (≥38°C) reduced from 86% to 75% in infants who received concomitant administration of 4CMenB with routine vaccines compared with the cumulative incidence of AEFIs when vaccines were administered separately (1-month intervals).Citation22 Substantial reductions in the co-administration group versus separate vaccination were also reported for other AEFIs, including diarrhea, crying, and change in eating habits; however, a slight increase in the occurrence of tenderness at the site of injection was reported in infants who received concomitant versus separate vaccinations (66% vs 55%).Citation22 Overall, co-administration of 4CMenB reduced the cumulative risk of AEFIs by 4–49%, and the severity of AEFIs was not increased by co-administration of 4CMenB with routine vaccines, compared with separate vaccination.Citation22
Co-administration of 4CMenB with DTaP-Hib-IPV-HepB and PCV is currently in use in Portugal,Citation31 and in regional vaccination calendars across Spain.Citation32,Citation33 The value of vaccine co-administration is further highlighted by the Italian experience of concomitant MenC vaccination with two injectable vaccines (DTaP-Hib-IPV-HepB and PCV) in infants aged <12 months.Citation34 Following one year of implementation, Pellegrino et al.Citation34 reported a significant increase in vaccine coverage, from 46.9% to 64.8%, following co-administration of PCV, hexavalent, and MenC vaccines. MenC vaccination was however later re-scheduled to occur in children aged 2 y (one dose).Citation35
In Italy, the NIP was updated in 2023 (NVPP 2023–2025),Citation14 introducing the option to co-administer 4CMenB, DTaP-Hib-IPV-HepB, PCV, and RV vaccines at 3 months and 5 months of age, thus halving the number of vaccination sessions required (a third session may occur at 4 months of age, should the 3-dose schedule for the RV vaccine be utilized). Supportive of this recommendation, the regional immunization calendar for Calabria was updated in 2022, ahead of the NIP update, introducing the option to also co-administer the measles-mumps-rubella-varicella vaccine (MMRV) with 4CMenB and MenC or meningococcal A, C, W, and Y (MenACWY) conjugated polysaccharide vaccines at 13–15 months of age.Citation36 Furthermore, the Centers for Disease Control and Prevention state that all vaccines have the possibility to be co-administered, unless there is a documented contraindication,Citation37 and the World Health Organization recommends the co-administration of many vaccines throughout the early stages of infancy.Citation38
The potential benefits of full co-administration of pediatric vaccines in the Italian context have been underlined by Poscia et al.Citation39 By using the 2019 birth cohort in Italy, and assuming that 10 regions use the two-dose RV vaccine and 10 regions use the three-dose RV vaccine, with a target coverage of 95%, it was estimated that 950,190 vaccination appointments would be saved per year, leading to a forecast of 190,038 working hours per year that could be reinvested in other vaccination activities.Citation39 The feasibility of full co-administration of pediatric vaccines, as recommended by the NVPP 2023–2025,Citation14 was documented in the Local Health Unit of Reggio Calabria at an Italian Continued Medical Education seminar in April 2023.Citation40 Following the introduction of the option for full co-administration in the Calabria Immunization Calendar in April 2022,Citation15 the proportion of patients who had chosen for their child to receive full co-administration increased from 37.33% in May 2022 to 86.17% in March 2023.Citation40 Despite this, two surveys carried out among HCPs in Italy highlighted that the lack of information on vaccine co-administration provided in relevant data sheets is perceived as a key barrier to implementation,Citation15,Citation16 although this may have been overcome by the subsequent updated NVPP 2023–2025 recommendations.Citation14 Coupled with public perceptions that administering multiple vaccines at once may burden the immune system, impact vaccine efficacy, or increase the frequency of AEFIs,Citation41 wider communication of safety profiles for vaccine co-administration is imperative.
Despite the few studies identified, the findings and discussion presented in this review highlight the lack of safety signals and new AEFIs when co-administering 4CMenB with two or more vaccines versus separate immunization. In some cases, vaccine co-administration resulted in lower overall AEFIs and increased vaccine coverage compared with separate vaccination. This is also pertinent with the recommendation in 2024 by the German Standing Committee on Vaccination (STIKO) for the co-administration of 4CMenB with PCV, hexavalent and RV vaccines, as discussed in this review.Citation42 However, there were limitations to this review. First, the literature searches and selection of studies were performed by one researcher, and no quality assessments of the included studies were conducted. Only two studies were included as results, of which all reported data solely from the UK. In addition, there was a lack of safety data in this context for hexavalent versus pentavalent vaccines. Taken together, this may highlight a need for analyses of pooled safety data on 4CMenB co-administration with hexavalent vaccines, and PCV and RV vaccines. Current data may also lack global representation.
Conclusions
Co-administration of multiple vaccines, compared with independent vaccination, can provide many benefits to healthcare systems, parents, and individuals receiving the vaccine, such as a reduced number of vaccination sessions. However, confidence on the safety profile of vaccines when co-administered in infants is necessary to support use in practice, both from the perspective of HCPs, caregivers, and vaccinated individuals.
This review highlighted that within the context of co-administering 4CMenB with two injectable vaccines and one oral vaccine, overall rates of AEFIs were similar or reduced in some instances. The ongoing experience of the Calabria region in Italy, that recently introduced the option to co-administer vaccines at 3 months, 5 months, and 13–15 months,Citation36 and the similar co-administration opportunity offered by the updated NIP in Italy,Citation14 are expected to provide further insight on the impact of 4CMenB co-administration. Vaccine co-administration safety/tolerability data reported in the literature do not show an increased risk of AEFIs compared to vaccines administered individually.
Authors’ contributions
Substantial contributions to study conception and design: PB, SC, GG, SG, FM, RR, RP, and FV; substantial contributions to analysis or interpretation of the data: PB, SC, GG, SG, FM, RR, RP, and FV; drafting the article or revising it critically for important intellectual content: PB, SC, GG, SG, FM, RR, RP, and FV; final approval of the version of the article to be published: PB, SC, GG, SG, FM, RR, RP, and FV.
Acknowledgments
The authors thank Costello Medical for editorial assistance and publication coordination, on behalf of GSK, and acknowledge Samuel Shields, Costello Medical, UK for medical writing and editorial assistance based on authors’ input and direction.
Disclosure statement
SC and FM: employee and stock owner of the GSK group of companies. GG: received consulting fees from the GSK group of companies, Sanofi Pasteur, MSD, and Moderna; payment or honoraria from the GSK group of companies, MSD, Pfizer, Moderna, Sanofi Pasteur, Novavax and Seqirus; support for attending meetings and/or travel from the GSK group of companies, Sanofi Pasteur, and MSD; participated on a Data Safety Monitoring Board or Advisory Board for the GSK group of companies, Sanofi Pasteur, MSD, and Moderna; and has had an unpaid leadership or fiduciary role in the Italian Scientific Society of Hygiene, Preventive Medicine and Public Health; PB: received payment or honoraria from the GSK group of companies, MSD, Moderna, Pfizer, Sanofi, Astra Zeneca, Janssen, and Seqirus; RP: received consulting fees, payment or honoraria from the GSK group of companies, MSD, and Sanofi; support for attending meetings and/or travel from MSD, Sanofi, and Novavax; FV, RR, and SG: no conflicts of interest to declare.
Data availability statement
The authors confirm that the data supporting the findings of this study are available within the article.
Additional information
Funding
References
- Bauwens J, de Lusignan S, Sherlock J, Ferreira F, Künzli N, Bonhoeffer J. Co-administration of routine paediatric vaccines in England often deviates from the immunisation schedule. Vaccine. 2021;9:100115. doi:10.1016/j.jvacx.2021.100115.
- Bonanni P, Steffen R, Schelling J, Balaisyte-Jazone L, Posiuniene I, Zatoński M, Van Damme P. Vaccine co-administration in adults: an effective way to improve vaccination coverage. Hum Vaccin Immunother. 2023;19(1):2195786. doi:10.1080/21645515.2023.2195786.
- Durando P, Esposito S, Bona G, Cuccia M, Desole MG, Ferrera G, Gabutti G, Pellegrino A, Salvini F, Henry O, et al. The immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine when co-administered with conjugated meningococcal C vaccine to healthy children: a phase IIIb, randomized, multi-center study in Italy. Vaccine. 2016;34(36):4278–6. doi:10.1016/j.vaccine.2016.07.009.
- Sinopoli MT, Belfiori G, Fusillo T. Le co-somministrazioni come strumento per raggiungere e mantenere le coperture vaccinali previste dal pnpv nel primo anno di vita. In: Atti 54° Congresso Nazionale SITI 2021; Lecce, Italy; 2021.
- Turner N, Grant C, Goodyear-Smith F, Petousis-Harris H. Seize the moments: missed opportunities to immunize at the family practice level. Family Practice. 2009;26(4):275–8. doi:10.1093/fampra/cmp028.
- Boeddha NP, Schlapbach LJ, Driessen GJ, Herberg JA, Rivero-Calle I, Cebey-López M, Klobassa DS, Philipsen R, de Groot R, Inwald DP, et al. Mortality and morbidity in community-acquired sepsis in European pediatric intensive care units: a prospective cohort study from the European Childhood Life-threatening Infectious Disease Study (EUCLIDS). Crit Care. 2018;22(1):143. doi:10.1186/s13054-018-2052-7.
- Burnett E, Parashar U, Tate J. Rotavirus vaccines: effectiveness, safety, and future directions. Paediatr Drugs. 2018;20(3):223–33. doi:10.1007/s40272-018-0283-3.
- Azzari C, Moriondo M, Nieddu F, Guarnieri V, Lodi L, Canessa C, Indolfi G, Giovannini M, Napoletano G, Russo F, et al. Effectiveness and impact of the 4CMenB vaccine against group B meningococcal disease in two Italian regions using different vaccination schedules: a five-year retrospective observational study (2014–2018). Vaccines. 2020;8(3):8. doi:10.3390/vaccines8030469.
- Bonanni P, Conforti G, Franco E, Gabutti G, Marchetti F, Matte A, Prato R, Vitali Rosati G, Vitale F Fourteen years’ clinical experience and the first million babies protected with human live-attenuated vaccine against rotavirus disease in Italy. Hum Vaccin Immunother. 2021;17:4636–45 doi:10.1080/21645515.2021.1955611.
- Lodi L, Barbati F, Amicizia D, Baldo V, Barbui AM, Bondi A, Costantino C, Da Dalt L, Ferrara L, Fortunato F, et al. Four-component recombinant protein–based vaccine effectiveness against serogroup B meningococcal disease in Italy. JAMA Netw Open. 2023;6(8):e2329678. doi:10.1001/jamanetworkopen.2023.29678.
- Azzari C, Canessa C, Lippi F, Moriondo M, Indolfi G, Nieddu F, Martini M, de Martino M, Castiglia P, Baldo V, et al. Distribution of invasive meningococcal B disease in Italian pediatric population: implications for vaccination timing. Vaccine. 2014;32(10):1187–91. doi:10.1016/j.vaccine.2013.09.055.
- Vaccinazioni dell’età pediatrica. Anno 2021 (coorte 2019). Coperture vaccinali a 24 mesi (per 100 abitanti). [accessed 2023 Apr 13]. https://www.salute.gov.it/imgs/C_17_tavole_20_10_0_file.pdf.
- Bauwens J, Saenz LH, Reusser A, Künzli N, Bonhoeffer J. Safety of Co-administration versus separate administration of the same vaccines in children: a systematic literature review. Vaccines. 2019;8(1):12. doi:10.3390/vaccines8010012.
- Ministero della Salute. Piano Nazionale Prevenzione Vaccinale 2023–2025. [accessed 2023 Sep]. https://www.trovanorme.salute.gov.it/norme/dettaglioAtto.spring?id=95963&page=newsett.
- Giuffrida S, Seta G, Gurnari A, Fiasca F, Marchetti F. Insights and expectations of healthcare professionals on the implementation of the updated pediatric regional immunization calendar in Calabria, Italy. Hum Vaccin Immunother. 2023;19(3):2275475. doi:10.1080/21645515.2023.2275475.
- Barbato M, Rosselli R, Russo C, Butera A, Esposito L, Fiasca F, Cavallo M Results of the first national survey on vaccines co-administration knowledge and beliefs carried out among Italian health assistants. Popul Med. 2023;5(Supplement). doi:10.18332/popmed/165298.
- Wagner A, Kundi M, Zwiauer K, Wiedermann U. Paediatricians require more information before they routinely co-administer the meningococcal B vaccine with routine infant vaccines. Acta Paediatrica. 2015;104(10):439–47. doi:10.1111/apa.13100.
- Liu B, Cao B, Wang C, Han B, Sun T, Miao Y, Lu Q, Cui F. Immunogenicity and safety of childhood combination vaccines: a systematic review and meta-analysis. Vaccines. 2022;10(3):10. doi:10.3390/vaccines10030472.
- Bauwens J, de Lusignan S, Weldesselassie YG, Sherlock J, Künzli N, Bonhoeffer J. Safety of routine childhood vaccine coadministration versus separate vaccination. BMJ Glob Health. 2022;7(9):e008215. doi:10.1136/bmjgh-2021-008215.
- Bryan P, Seabroke S, Wong J, Donegan K, Webb E, Goldsmith C, Vipond C, Feavers I. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;2(6):395–403. doi:10.1016/S2352-4642(18)30103-2.
- European Medicines Agency. Bexsero summary of product characteristics. [accessed 2024 Feb]. https://www.ema.europa.eu/en/documents/product-information/bexsero-epar-product-information_en.pdf.
- Zafack JG, Bureau A, Skowronski DM, De Serres G. Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials. BMJ Open. 2019;9(5):e026953. doi:10.1136/bmjopen-2018-026953.
- Abitbol V, Sohn W-Y, Horn M, Safadi, MAP. Safety and immunogenicity of co-administered meningococcal serogroup B (4CMenB) vaccine: a literature review. Hum Vaccines Immunother. 2023;19:2245705. doi:10.1080/21645515.2023.2245705.
- O’Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014;74(1):15–30. doi:10.1007/s40265-013-0155-7.
- Gossger N, Snape MD, Yu L-M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. JAMA. 2012;307(6):573–582. doi:10.1001/jama.2012.85.
- Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381(9869):825–35. doi:10.1016/S0140-6736(12)61961-8.
- Martinelli D, Fortunato F, Marchetti F, Prato R. Rotavirus vaccine administration patterns in Italy: potential impact on vaccine coverage, compliance and adherence. Hum Vaccin Immunother. 2021;17(5):1546–51. doi:10.1080/21645515.2020.1816109.
- UK Health Security Agency. The complete routine immunisation schedule from February 2022. [accessed 2023 July]. https://www.gov.uk/government/publications/the-complete-routine-immunisation-schedule/the-complete-routine-immunisation-schedule-from-february-2022.
- Rajan M, Marchevsky N, Sinclair G, O’Brien K, Jefferies K, Owino N, Hallis B, Goldblatt D, Matheson M, Cuthbertson H, et al. A randomized trial assessing the immunogenicity and reactogenicity of two hexavalent infant vaccines concomitantly administered with group B meningococcal vaccine. Pediatr Infect Dis J. 2023;42(1):66–73. doi:10.1097/INF.0000000000003753.
- UK Health Security Agency. Using paracetamol to prevent and treat fever after MenB vaccination. [accessed 2023 Sep]. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1110220/UKHSA-paracetamol-MenB-2022.pdf.
- European Centre for Disease Prevention and Control. E-CDC Scheduler. [accessed 2024 Feb]. https://vaccine-schedule.ecdc.europa.eu/.
- Junta of Castile and León. Calendario Vacunal Para Toda La Vida. [accessed 2024 Feb]. https://www.saludcastillayleon.es/profesionales/es/vacunaciones/calendario-vacunal-toda-vida-castilla-leon-2023.ficheros/2428566-calendario%20vacunal%20def%20%2850x70%29.pdf.
- De Galicia X. Calendario De Inmunización A Lo Largo De Toda La Vida. [accessed 2024 Feb]. https://www.sergas.es/Saude-publica/Documents/7247/INS_CALENDARIO_INMUNIZACION_13-11-2023%20(ES).pdf.
- Pellegrino A, Busellu G, Cucchi A, Cavallaro A, Gabutti G. Vaccine co-administration in paediatric age: the experience of the local health unit of cuneo-1 (Ambito di cuneo), Italy. Acta Biomed. 2010;81:204–9.
- Ministero della Salute. Piano Nazionale Prevenzione Vaccinale 2017–2019. [accessed 2024 Feb]. https://www.salute.gov.it/imgs/C_17_pubblicazioni_2571_allegato.pdf.
- Regione Calabria. Calendario Vaccinale Regione Calabria. 2022. [accessed 2023 Feb]. https://www.regione.calabria.it/website/portalmedia/decreti/2022-04/All.-DCA-32-del-7.4.2022-_Calendario-Vaccinale-Regionale.pdf.
- Centers for Disease Prevention and Control. CDC pink book General rules for immunization. [accessed 2024 Feb]. https://www.cdc.gov/vaccines/pubs/pinkbook/genrec.html.
- World Health Organization. WHO recommendations for routine immunization – summary tables. [accessed 2024 Aug]. https://www.who.int/teams/immunization-vaccines-and-biologicals/policies/who-recommendations-for-routine-immunization---summary-tables.
- Poscia A, Lo Giudice M, Nigri L, Perone V, Russo R, Bresesti I, Agosti M. Italian immunization calendar implementation: Time to optimize number of vaccination appointments? Hum Vaccin Immunother. 2023;19(1):2156745. doi:10.1080/21645515.2022.2156745.
- Giuffrida SC. L’esperienza della Regione Calabria sul calendario vaccinale. CME Webinar – 15 April 2023 – The Healthcare Assistant and Vaccinations In a Context Of Continuous Change. 2023 [accessed 2024 Feb]. https://www.vaccinarsintoscana.org/eventi/2023/15.04.2023-webinar-ecm-l%E2%80%99assistente-sanitario-e-le-vaccinazioni-in-un-contesto-di-cambiamento-continuo.
- Bonanni P, Boccalini S, Bechini A, Varone O, Matteo G, Sandri F, Gabutti G. Co-administration of vaccines: a focus on tetravalent Measles-Mumps-Rubella-Varicella (MMRV) and meningococcal C conjugate vaccines. Hum Vaccin Immunother. 2020;16(6):1313–21. doi:10.1080/21645515.2019.1688032.
- Robert Koch Institut. Epidemiologisches Bulletin 4 2024. [accessed 2024 Feb]. https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2024/Ausgaben/04_24.pdf?__blob=publicationFile.