Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines

BACKGROUND: This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or nonconcomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis]). METHODS: Participants received 9vHPV vaccine at day 1 and months 2 and 6; the concomitant group (n = 621) received MCV4/Tdap concomitantly with 9vHPV vaccine at day 1; the nonconcomitant group (n = 620) received MCV4/Tdap at month 1. Antibodies to HPV-, MCV4-, and Tdap-relevant antigens were determined. Injection-site and systemic adverse events (AEs) were monitored for 15 days after any vaccination; serious AEs were monitored throughout the study. RESULTS: The geometric mean titers for all HPV types in 9vHPV vaccine 4 weeks after dose 3, proportion of subjects with a fourfold rise or greater in titers for 4 N meningitidis serotypes 4 weeks after injection with MCV4, proportion of subjects with antibody titers to diphtheria and tetanus ≥0.1 IU/mL, and geometric mean titers for pertussis antigens 4 weeks after injection with Tdap were all noninferior in the concomitant group compared with the nonconcomitant group. Injection-site swelling occurred more frequently in the concomitant group. There were no vaccine-related serious AEs. CONCLUSIONS: Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

BACKGROUND: Intussusception (IS) is a form of acute intestinal obstruction that occurs mainly in infants and is usually of unknown cause. An association between IS and the first licensed rotavirus vaccine, a reassortant-tetravalent, rhesus-based rotavirus vaccine (RRV-TV), led to the withdrawal of the vaccine. New rotavirus vaccines have now been developed and extensively studied for their potential association with IS. This study aimed to describe the epidemiology and to estimate the incidence of IS in Latin American infants prior to new vaccine introduction. METHODS: Children under 2 years of age representing potential IS cases were enrolled in 16 centers in 11 Latin American countries from January 2003 to May 2005. IS cases were classified as definite, probable, possible or suspected as stated on the Brighton Collaboration Working Group guidelines. RESULTS: From 517 potential cases identified, 476 (92%) cases were classified as definite, 21 probable, 10 possible and 10 suspected for intussusception. Among the 476 definite IS cases, the median age at presentation was 6.4 months with 89% of cases aged <1 year. The male to female ratio was 1.5:1. The incidence of definite IS per 100,000 subject-years ranged from 1.9 in Brazil to 62.4 in Argentina for children <2 years of age, and from 3.8 in Brazil to 105.3 in Argentina for children aged <1 year. Median hospital stay was 4 days with a high prevalence of surgery as the primary treatment (65%). Most cases (88%) made a complete recovery, but 13 (3%) died. No clear seasonal pattern of IS cases emerged. CONCLUSIONS: This study describes the epidemiology and estimates the incidence of IS in Latin American infants prior to the introduction of new rotavirus vaccines. The incidence of IS was found to vary between different countries, as observed in previous studies. TRIAL REGISTRATION: Clinical study identifier 999910/204 (SERO-EPI-IS-204

Factors Associated with the Duration of Breastfeeding: The Practices of Mexican Mothers in a Megacity and in the Agricultural Town

Background: Breast milk is irreplaceable for healthy development. In Mexico, by 2019, the prevalence of exclusive breastfeeding (EBF) was low and the use of breastmilk substitutes (BMSs) was high. Objective: The aim of this work was to evaluate the maternal and child characteristics related to breastfeeding (BF) duration and to the introduction of BMSs for residents of Mexico City (CdMX) and an agricultural town in Morelos. Methods: A cross-sectional study was conducted with 160 mother&ndash;child binomials (0&ndash;15 months of age) from the megacity CdMX and the agricultural town. Outcomes: EBF and total breastfeeding (TBF) duration, age of transition to BMSs, and the introduction of complementary feeding (CF) were assessed. Associations with maternal and infant factors were assessed using Cox models. Results: The prevalence of EBF in the joint samples at 5.9 months was 32.6% and 5.8% at 6 months. EBF was favored under the following conditions: living in CdMX, receiving prenatal care, no newborn hospitalization, and breastmilk provided as first food at birth. TBF was prolonged under the following conditions: older mother, female children, rooming-in care during puerperium, receiving BF upon discharge after birth, cohabiting with extended family, and having no siblings. The introduction of BMSs predominated under the following conditions: living in an agricultural town, BMSs given after birth before discharge, younger mother, worker mother, and lack of prenatal care. The early introduction of CF (before the fourth month) was 2% for CdMX and 14% for the agricultural town. Conclusions: The agricultural population had a higher risk of the premature interruption of EBF/TBF and the early introduction of BMSs and CF. Protective factors were family-friendly environments and being born in a baby-friendly hospital

Economic burden of varicella complications in two referral centers in Mexico

Varicella-zoster virus causes varicella (chicken-pox), mainly in young children. Most cases are mild but serious complications can occur, resulting in significant morbidity and mortality. The objective of this study was to estimate the cost burden of varicella hospitalizations in two pediatric reference hospitals in Mexico. This retrospective observational study collected data on patients aged <18 years admitted to two third-level referral hospitals in Mexico. Cases were identified from hospital records using International Classification of Diseases Ninth Revision (ICD-9) codes 052 Chickenpox, or Tenth Revision (ICD-10) codes B01 Varicella (chickenpox). Data on demographic and clinical characteristics and resource use were collected from hospital records. Costs for hospital stay and interventions were obtained from the Mexican Institute for Social Security for 2015 and updated to 2017 costs. A total of 172 hospitalized varicella clinically-confirmed cases and 121 varicella- contacts (with epidemiological linkage to a clinically-confirmed case) were included. Thirty eight of the 172 cases (22.0%) experienced complications. There were no deaths. The median duration of hospitalization was 12 days for cases and 23 days for contacts. The median hospitalization cost was MXN 82,572 (USD 4,434) per case, and MXN 89,453 (USD 4,804) per contact. Although considered a mild disease, varicella was associated with a substantial cost burden in two Mexican third-level referral hospitals

Rotavirus gastroenteritis in Latin America: a hospital-based study in children under 3 years of age

GlaxoSmithKline (GSK) Biologicals was the funding source and was involved in all stages of the study conduct and analysis. GSK Biologicals also funded all costs associated with the development and the publishing of the present manuscript.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Belém, PA, Brasil.Instituto Nacional de Pediatría. México D.F., Mexico.Hospital del Niño. Panama City, Panama.Universidad de Valparaíso. Escuela de Medicina. Valparaíso, Chile.Instituto Costarricense de Investigaciones Clínicas. Urbanización de Los Arboles La Uruca. San José, Costa Rica.Instituto Mexicano del Seguro Social. CMN-SXX. Pediatrics Hospital. Medical Research Unit on Infectious Diseases. Mexico City, Mexico.GlaxoSmithKline Biologicals México. México D.F., México.Hospital Dr. Humberto Notti. Villa Nueva de Guaymallén, Mendoza, Argentina.Hospital Maternidad Nuestra Sra de la Altagracia. Santo Domingo, D.N., Dominican Republic.GlaxoSmithKline Biologicals Argentina. Victoria, Buenos Aires, Argentina.Organización para el Desarrollo y la Investigación Salud en Honduras. Colonia Humuya, Sendero Pastizal, Tegucigalpa, Honduras.Ciudad Hospitalaria Dr. Enrique Tejera. Hospital de Niños Dr. Jorge Lizarraga. Carabobo, Valencia, Venezuela.Fundación para el Avance de la Investigación Clínica y Translacional. Consultores Médicos América. Vía España, Carrasquilla, Panama.GlaxoSmithKline Biologicals Costa Rica. San Jose, Costa Rica.GlaxoSmithKline Biologicals Belgium. Rixensart, Belgium.Rotavirus is the leading cause of severe diarrheal disease and dehydration in infants in both developed and developing countries. Vaccines have recently been developed, but detailed epidemiological information, which is needed for decisions about how and where to introduce vaccination, was lacking for many Latin American countries. The primary objective of this study was to measure the incidence and disease burden of rotavirus in young children presenting to Latin American hospitals with gastroenteritis. In addition it allowed to setting up the methodology to further conduct a large phase III trial with a rotavirus vaccine in the region. This was a prospective, multi-center surveillance study of gastroenteritis in children <3 years old presenting to hospitals in 11 Latin American countries. Questionnaires and stool samples were collected from 6521 of 8031 enrolled cases (73% inpatients). Among these, 3122 (49%) were rotavirus positive. Of the rotavirus-positive cases, 12% were <6 months, 48% <1 year and 87% <2 years old; 23% received antibiotics before diagnosis. Median hospital stay was 2 days, 78% received intravenous rehydration. Overall strain distribution was G1 (59%), G2 (1%), G3 (12%), G4 (20%), G9 (6%), G12 (1%), untypable (7%) with large local variations. The direct economic impact on families was considerable: 48% of caregivers lost time from paid work and 69% of families were financially affected by their child's illness. This study confirms the high disease burden of rotavirus gastroenteritis among children in Latin America, which might be reduced by the use of effective vaccines

A multi-country study of intussusception in children under 2 years of age in Latin America: analysis of prospective surveillance data

Hospital del Niño. Infectious Disease Department. Ciudad de Panamá, Panama.Instituto Mexicano del Seguro Social. Medical Research Unit on Infectious Diseases. CMN-SXXI. Mexico City, Mexico.Centro de Estudios en Infectologia Pediatrica. Clinica Materno Infantil Los Farallones. Cali, Colombia.Universidad Nacional Autónoma de Nicaragua. Edificio Central. Leόn, Nicaragua.Ministério da Saúde. Secretaria de Vigilância em Saúde. Instituto Evandro Chagas. Ananindeua, PA, Brasil.Hospital Dr. Humberto Notti. Villa Nueva de Guaymallén, Mendoza, ArgentinaUniversidad de Concepción. Concepción, Chile.Universidad de Concepción. Concepción, Chile.Universidad de Valparaíso. Escuela de Medicina. Valparaíso, Chile.Hospital Nacional de Niños. Paseo Colón, San José, Costa Rica.Organización para el Desarrollo y la Investigación Salud en Honduras. Colonia Humuya, Tegucigalpa, Honduras.Hospital General de Tlanepantla “Valle Ceylán”. Tlanepantla, Mexico.Hospital Infantil de Mexico. Calle Dr. Márquez . México DF, Mexico / Ministry of Health. National Center for Child and Adolescent Health. Colonia Merced Gomez, Mexico DF, Mexico.Instituto Nacional de Pediatría. México DF, Mexico.Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Mexico DF, Mexico.Hospital Maternidad Nuestra Sra de la Altagracia. Santo Domingo, DN, República Dominicana.Fundación para el Avance de la Investigación Clínica y Translacional, Consultorios Médicos América. Vía España, Carrasquilla, Panama / GlaxoSmithKline Vaccines. Clayton, Panama.GlaxoSmithKline Vaccines México. México DF, Mexico.GlaxoSmithKline Vaccines Argentina. Buenos Aires, Argentina / Independent Medical Professional. Buenos Aires, Argentina.GlaxoSmithKline Vaccines Costa Rica. San Jose, Costa Rica / GlaxoSmithKline Vaccines. Ciudad del Saber, Clayton, Panama.GlaxoSmithKline Vaccines. Philadelphia, USA / Merck & Co., Global Health Outcomes Vaccines. Philadelphia, PA, USA.GlaxoSmithKline Vaccines. Rixensart, Belgium / Philadelphia Department of Public Health. Philadelphia, USA.GlaxoSmithKline Vaccines. Rixensart, Belgium / P95 Excellence in Pharmacovigilance and Epidemiology, Leuven, Belgium.GlaxoSmithKline Vaccines. Rixensart, Belgium / GlaxoSmithKline Vaccines, Parc de la Noire Epine. Wavre, Belgium.Background: Intussusception (IS) is a form of acute intestinal obstruction that occurs mainly in infants and is usually of unknown cause. An association between IS and the first licensed rotavirus vaccine, a reassortanttetravalent, rhesus-based rotavirus vaccine (RRV-TV), led to the withdrawal of the vaccine. New rotavirus vaccines have now been developed and extensively studied for their potential association with IS. This study aimed to describe the epidemiology and to estimate the incidence of IS in Latin American infants prior to new vaccine introduction. Methods: Children under 2 years of age representing potential IS cases were enrolled in 16 centers in 11 Latin American countries from January 2003 to May 2005. IS cases were classified as definite, probable, possible or suspected as stated on the Brighton Collaboration Working Group guidelines. Results: From 517 potential cases identified, 476 (92 per cent) cases were classified as definite, 21 probable, 10 possible and 10 suspected for intussusception. Among the 476 definite IS cases, the median age at presentation was 6.4 months with 89 per cent of cases aged 1 year. The male to female ratio was 1.5:1. The incidence of definite IS per 100,000 subject-years ranged from 1.9 in Brazil to 62.4 in Argentina for children 2 years of age, and from 3.8 in Brazil to 105.3 in Argentina for children aged 1 year. Median hospital stay was 4 days with a high prevalence of surgery as the primary treatment (65 per cent). Most cases (88 per cent) made a complete recovery, but 13 (3 per cent) died. No clear seasonal pattern of IS cases emerged. Conclusions: This study describes the epidemiology and estimates the incidence of IS in Latin American infants prior to the introduction of new rotavirus vaccines. The incidence of IS was found to vary between different countries, as observed in previous studies

Etiology of Acute Otitis Media in Children Less Than 5 Years of Age

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Safety and immunogenicity of a ChAd155-vectored respiratory syncytial virus vaccine in infants 6–7 months of age: a phase 1/2 randomized trial

Background: respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants.Methods: healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years.Results: two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post–ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post–dose 2.Conclusions: ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response.Clinical trials registration: NCT03636906