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Background The effectiveness of SMS reminders in improving vaccination coverage has been assessed previously, with effectiveness varying between settings. However, there are very few studies on their effect on the timeliness of vaccination. Design Unblinded, randomised controlled trial with blocked sampling. Methods 1594 Australian infants and young children were recruited to assess the impact of (1) SMS reminders only, (2) a personalised calendar, (3) SMS reminder and personalised calendar and (4) no intervention, on receipt of vaccine within 30 days of the due date. Outcomes were measured for receipt of vaccines due at 2, 4, 6, 12 and 18 months of age. A post-hoc assessment was also conducted of the impact of a new national “No jab No Pay” policy introduced during the trial, which removed philosophical objections as an exemption for financial penalties for non-vaccination. Results There was a statistically significant improvement in on-time vaccination only at the 12 month schedule point amongst infants who received SMS reminders alone (RR 1.09, 95% CI 1.01–1.18) or in combination with a personalised calendar (1.11, CI 1.03–1.20) compared to controls. This impact was limited to participants who had received one or more previous doses late. No statistically significant impacts of calendar interventions alone were seen. There was a high rate of on-time compliance amongst control participants − 95%, 86%, 80%, 74% at the 4, 6, 12 and 18 month schedule points respectively, which increased more than 10 percentage points after implementation of the “No Jab, No Pay” policy. Conclusions SMS reminders are more effective in improving timeliness where pre-existing compliance is lower, but the 18 month schedule point appeared to be less amenable to intervention. Australia and New Zealand Clinical Trial Registration No. ACTRN12614000970640.

Background Pregnant women are considered the most important risk group for influenza vaccination. Despite this, the potential risk of harm from the vaccine on the fetus is a key factor in low uptake of the vaccine. This systematic review aimed to synthesize the best available evidence on the safety of influenza vaccination during pregnancy on fetal development. Methods and findings A search of the literature was undertaken from the inception of each database up to March 2014. Both observational and clinical trials were considered. Fetal outcomes were present in 19 observational studies, and 14 of those were primarily investigating the monovalent influenza A (H1N1) 2009 vaccine. There was significant methodological and clinical heterogeneity of the included studies and a narrative summary and tabling of results was performed. Fetal death outcomes for women in later pregnancy ranged from OR 0.34 to 2.95 with 95% confidence intervals crossing or below the null value. Spontaneous abortion less than 24 weeks ranged from HR 0.45 to OR 1.23, with 95% confidence intervals crossing or below the null value. Congenital malformations for women vaccinated during their first trimester ranged from OR 0.67 to 2.18 and imprecise confidence intervals crossed the null value. Included in this review were some high quality studies, although overall the studies have a high risk of selection and confounding bias. Conclusions Results do not indicate that maternal influenza vaccination is associated with an increased risk of fetal death, spontaneous abortion, or congenital malformations. Statistical imprecision and clinical and methodological heterogeneity of the observational studies mean it is not possible to totally exclude adverse effects. Further studies investigating women vaccinated during their first trimester should be the highest priority to allow for more precise estimates, especially for spontaneous abortion, and congenital abnormality outcomes.

Need for developing case definitionsand guidelines for data collection, analysis, and presentation for stillbirth as an adverse event following immunization during pregnancy.