Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting

Contribution of Mexico's Universal Immunization Program to the Fourth Millennium Development Goal

OBJECTIVE: To identify and describe 1) progress achieved thus far in meeting the commitments of the Fourth Millennium Development Goal (MDG 4) in Mexico, mainly the contribution of the Universal Immunization Program (UIP) over the last 20 years, and 2) new opportunities for further reducing mortality among children under 5 years old. METHODS: An observational, descriptive, retrospective study was carried out to examine registered causes of death in children under 5 between 1990 and 2010. Indicators were built according to the recommendations of the United Nations. RESULTS: In 2010, deaths among children under 5 decreased 64.3% compared to the baseline (1990) figure. Of the total deaths of the children under 5, the neonatal period was the most affected (52.8%), followed by the 1 to 11 months (30.9%), and the 12 to 59 months (16.2%) groups. A 34% overall mortality reduction was observed after the universalization of immunization against influenza, rotavirus, and pneumococcus in children under 5. CONCLUSIONS: Despite a significant reduction in under-5 mortality in Mexico over the last 20 years, largely due to the successes of the UIP, several challenges remain, particularly in improving preventive and curative services during pre- and postnatal care

Intention to accept pertussis vaccine among pregnant women in Karachi, Pakistan

Background: Maternal immunization against pertussis is a potential strategy to protect young infants from severe disease. We assessed factors associated with intention to accept pertussis vaccination among pregnant women in Karachi, Pakistan.Methods: We conducted a cross-sectional survey between May and August 2013 in pregnant women who visited healthcare centers in urban slums of Karachi city. Women completed a survey examining socio-demographic factors, vaccination history, knowledge on pertussis disease, perception of vaccine recommendation sources, and potential influences on vaccine decision-making.Results: Of the 283 participants, 259 (92%) provided their intention to either accept or decline pertussis vaccination. Eighty-three percent women were willing to accept the pertussis vaccine if offered during pregnancy. About half (53%) of the participants had ever heard of pertussis disease. Perceptions of pertussis vaccine efficacy, safety, and disease susceptibility were strongly associated with intention to accept pertussis vaccine (p \u3c 0.01). Healthcare providers, Ministry of Health, and mass media were considered as highly reliable sources of vaccine recommendation and associated with intention to accept antenatal pertussis vaccination (p \u3c 0.001). Healthcare provider recommendation was a common reason cited by respondents for pregnant women to accept antenatal pertussis vaccination (p = 0.0005). However, opinion of primary decision-makers in the family (husbands and in-laws) was a crucial reason cited by respondents for pregnant women to reject pertussis vaccination in pregnancy (p = 0.003). Conclusion: Antenatal pertussis vaccination initiatives in South Asia should strongly consider inclusion of family members, healthcare providers, national health ministries, and mass media to help implement new vaccination programs

Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers : A Phase III, open-label, multi-center study

Booster doses of meningococcal conjugate vaccines induce long-term protection against invasive meningococcal disease. We evaluated the immunogenicity and safety of a booster dose of MenACYW-TT in pre-school children who were primed 3 years earlier with MenACYW-TT or MCV4-TT (Nimenrix®). In this Phase III, open-label, multi-center study (NCT03476135), children (4–5 years old), who received a primary dose of MenACYW-TT or MCV4-TT as toddlers in a previous study, received a booster dose of MenACYW-TT. Titers of antibody against meningococcal serogroups A, C, W and Y were measured by serum bactericidal assay using human (hSBA) and baby rabbit (rSBA) complement in samples collected before (D0) and 30 days after (D30) booster vaccination. Safety was assessed over the 30-day study period. Ninety-one participants received the booster dose. In both study groups, hSBA titers increased from D0 to D30; serogroup C titers [95% confidence interval] were higher in the MenACYW-TT-primed vs MCV4-TT-primed group at D0 (106 [73.2, 153] vs 11.7 [7.03, 19.4], respectively) and D30 (5894 [4325, 8031] vs 1592 [1165, 2174], respectively); rSBA results were similar. Nearly all participants achieved ≥1:8 hSBA and rSBA titers at D30, which were higher or comparable to those observed post-primary dose, suggesting rapid booster responses. At D0, all hSBA and rSBA titers were higher than those observed pre-primary dose, suggesting persistence of immunogenicity. The MenACYW-TT booster dose was well-tolerated and had similar safety outcomes across study groups. These findings suggest that MenACYW-TT elicits robust booster responses in children primed 3 years earlier with MenACYW-TT or MCV4-TT.publishedVersionPeer reviewe

Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting