Dose Of Pentavalent Vaccine Research Articles

Study of Serologic Response Rate to Pertussis after Administration of the Third Dose of Pentavalent Vaccine in Children 12 Months Old in Karaj City, Iran

Background: After substitution of Pentavalent vaccine with diphtheria, tetanus, pertussis (DTP) in the Iranian National Vaccination program with 3 Pentavalent (three times vaccination with Pentavalent vaccine at months 2, 4, and 6) in 2014 and the lack of published research in the field of immunogenicity of pertussis component of this vaccine, the efficacy of pertussis vaccine was studied 6 months after the last dose of Pentavalent vaccine in Iranian infants. Materials and Methods: Five hundred blood samples were collected from healthy one-year-old children who attended 18 health care centers of Karaj, Iran for routine vaccination selected by cluster sampling (2016). Sampling checklists contained demographic information and risk factors. The blood samples were sent to the laboratory for determination of Immunoglobulin G (IgG) and IgA anti-pertussis antibody titer by ELISA method. Data were analyzed by STATA software (version 14.0). Results: 82.7% (n=413) of children (95% confidence interval [CI]: 79.49-86.11) had IgG titer less than 16 IU/ml against pertussis (no immune response), and 17.3% (n=87) had equal or greater than 16 IU/ml IgG titer against pertussis (95% CI: 13.89-20.51). IgA titer against pertussis was less than 8U/ml in all cases. Anti-pertussis IgG geometric mean titer (GMT) was 15.80 U/ml (95% CI: 15.26-16.36), and IgA GMT was 6.26 U/ml (95% CI: 6.22-6.30). There was not a significant correlation between titer of pertussis antibody and demographic factors. Conclusion: Based on low IgG titer in vaccinated children, immunogenicity of pentavalent vaccine in Iranian children needs more investigation. In this study, 100 % of children had negative serologic response (IgA

SOCIO-ECONOMIC DETERMINANTS OF SUCESSIVE POLIO AND PENTAVALENT VACCINES UTILISATION AMONG UNDER FIVE CHILDREN IN GHANA

Objective: This study was conducted to investigate the factors that influence the utilisation of the successive doses of Polio and Pentavalent Vaccines among underfive children in Ghana. Method: The study used data from a cross sectional survey in the form of the 2014 Ghana Demographic and Health Survey which was carried out between early September and mid-December, 2014. The Probit model was the empirical model of estimation. Results: Among other findings, the study revealed that the region of residence influenced the utilisation of the initial and successive doses of both polio and pentavalent vaccines. Also rising birth order of the child was revealed to negatively influence the utilisation of all the doses of the polio and pentavalent vaccines. In addition, rising age of the household head was found to decrease the utilisation of the 3rd dose of the polio vaccine and the 2nd and 3rd doses of the pentavalent vaccine. Single mothers were also revealed to be less likely to utilise the 3rd dose of both vaccines for their children. Moreover, employed mothers were found to be more likely to utilise all the subsequent doses of both the pentavalent and polio vaccines for their children whiles mothers with secondary education were more likely to utilise both the 2nd and 3rd doses of the polio vaccine as well as the 3rd dose of the pentavalent vaccine for their children as compared with their uneducated counterparts. Conclusion: The study therefore concludes that public sensitisation programmes on childhood immunisation with regional focus and ethnic rulers’ partnerships, targeting of older household heads, uneducated, unemployed and single mothers as well women empowerment through employment and education are effective tools in ensuring Child health utilisation (immunisation) in Ghana.

A plea for introduction of hepatitisB vaccination at birth in Côte d'Ivoire

The Côte d'Ivoire National Immunization Technical Advisory Group 2015 work plan included elaboration of an opinion on inclusion of hepatitis B vaccination at birth in the Expanded Program on Immunization (EPI) in Côte d'Ivoire. A task force was set up to conduct this assessment according to a systematized method. The task force analysed scientific articles on the burden of hepatitis B in Côte d'Ivoire, the burden of mother-child transmission, the impact of hepatitis B vaccination at birth in countries which have adopted this strategy, the efficacy and safety of hepatitis B vaccine in newborns, the cost-effectiveness of hepatitis B vaccination at birth, and the best strategy to introduce hepatitis B vaccination at birth in the EPI. The National Immunization Technical Advisory Group of Côte d'Ivoire finally recommended introduction of a dose of hepatitis B vaccine at birth in the context of the Expanded Program on Immunization with maintenance of three doses of pentavalent vaccine (DPT-HepB-Hib) at 6, 10, and 14 weeks of age.

Using health-facility data to assess subnational coverage of maternal and child health indicators, Kenya.

ObjectiveTo develop a systematic approach to obtain the best possible national and subnational statistics for maternal and child health coverage indicators from routine health-facility data.MethodsOur approach aimed to obtain improved numerators and denominators for calculating coverage at the subnational level from health-facility data. This involved assessing data quality and determining adjustment factors for incomplete reporting by facilities, then estimating local target populations based on interventions with near-universal coverage (first antenatal visit and first dose of pentavalent vaccine). We applied the method to Kenya at the county level, where routine electronic reporting by facilities is in place via the district health information software system.FindingsReporting completeness for facility data were well above 80% in all 47 counties and the consistency of data over time was good. Coverage of the first dose of pentavalent vaccine, adjusted for facility reporting completeness, was used to obtain estimates of the county target populations for maternal and child health indicators. The country and national statistics for the four-year period 2012/13 to 2015/16 showed good consistency with results of the 2014 Kenya demographic and health survey. Our results indicated a stagnation of immunization coverage in almost all counties, a rapid increase of facility-based deliveries and caesarean sections and limited progress in antenatal care coverage.ConclusionWhile surveys will continue to be necessary to provide population-based data, web-based information systems for health facility reporting provide an opportunity for more frequent, local monitoring of progress, in maternal and child health.

Determinants of complete immunization among senegalese children aged 12\u201323\xa0months: evidence from the demographic and health survey

BackgroundThe expanded Programme on Immunization (EPI) is one of the most cost-effective interventions to reduce childhood mortality and morbidity. However, determinants of childhood immunization have not been well studied in Senegal. Thus, the aim of our study is to assess routine immunization uptake and factors associated with full immunization status among Senegalese children aged 12–23 months.MethodsWe used the 2010–2011 Senegalese Demographic and Health Survey data. The DHS was a two stages cross-sectional survey carried out in 2010–2011. The analysis included 2199 children aged 12–23 months. The interviewers collected information on vaccine uptake based on information from vaccination cards or maternal recall Univariate and multivariable logistic regressions models were used to identify the determinants of full childhood immunization.ResultsThe prevalence of complete immunization coverage among boys and girls based on both vaccination card information and mothers’ recall was 62.8%. The immunization coverage as documented on vaccination cards was 37.5%. Specific coverage for the single dose of BCG at birth, the third dose of polio vaccine, the third dose of pentavalent vaccine and the first dose of measles vaccine were 94.7%, 72.7%, 82.6%, and 82.1%, respectively. We found that mothers who could show a vaccination card [AOR 7.27 95% CI (5.50–9.60)], attended at least secondary education level [AOR 1.8 95% CI (1.20–2.48)], attended four antenatal visits [AOR 3.10 95% CI (1.69–5.63)], or delivered at a health facility [AOR 1.27 95% CI (1–1.74)] were the predictors of full childhood immunization. Additionally, children living in the eastern administrative regions of the country were less likely to be fully vaccinated [AOR 0.62 95% CI (0.39–0.97)].ConclusionsWe found that the full immunization coverage among children aged between 12 and 23 months was below the national (> 80%) and international targets (90%). Geographic area, mother’s characteristics, antenatal care and access to health care services were associated with full immunization. These findings highlight the need for innovative strategies based on a holistic approach to overcome the barriers to childhood immunization in Senegal.

Impact of the Ebola outbreak on routine immunization in western area, Sierra Leone - a field survey from an Ebola epidemic area

BackgroundSince March 2014, the Ebola Virus Disease (EVD) outbreak in West Africa disrupted health care systems - especially in Guinea, Liberia and Sierra Leone – with a consequential stress on the area’s routine immunization programs. To address perceived decreased vaccination coverage, Sierra Leone conducted a catch-up vaccination campaign during 24–27 April 2015. We conducted a vaccination coverage survey and report coverage estimates surrounding the time of the EVD outbreak and the catch-up campaign.MethodsWe selected 3 villages from each of 3 communities and obtained dates of birth and dates of vaccination with measles vaccine (MV) and the 3rd dose of Pentavalent vaccine (Pentavalent3) of all children under 4 years of age in the 9 selected villages. Vaccination data were obtained from parent-held health cards. We calculated the children’s MV and Pentavalent3 coverage rates at 3 time points, 1 August 2014, 1 April 2015, and 1 May 2015, representing coverage rates before the EVD outbreak, during the EVD outbreak, and after the Maternal and Child Health Week (MCHW) catch-up campaign.ResultsThe final sample size was 168 children. MV coverage among age-eligible children was 71.3% (95% confidence interval [CI]: 62.1% - 80.4%) and 45.7% (95% CI: 29.2% - 62.2%) before and during the outbreak of EVD, respectively, and was 56.8% (95% CI: 40.8% - 72.7%) after the campaign. Pentavalent3 coverage among age-eligible children was 79.8% (95% CI: 72.6% - 87.0%) and 40.0% (95% CI: 22.5% - 57.5%) before and during the outbreak of EVD, and was 56.4% (95% CI: 39.1% - 73.4%) after the campaign.ConclusionsCoverage levels of MV and Pentavalent3 were low before the EVD outbreak and decreased further during the outbreak. Although the MCHW catch-up campaign increased coverage levels, coverage remained below pre-outbreak levels. High-quality supplementary immunization activities should be conducted and routine immunization should be strengthened to address gaps in immunity among children in this EVD-affected area.

Mobile phone-delivered reminders and incentives to improve childhood immunisation coverage and timeliness in Kenya (M-SIMU): a cluster randomised controlled trial.

SummaryBackgroundAs mobile phone access continues to expand globally, opportunities exist to leverage these technologies to support demand for immunisation services and improve vaccine coverage. We aimed to assess whether short message service (SMS) reminders and monetary incentives can improve immunisation uptake in Kenya.MethodsIn this cluster-randomised controlled trial, villages were randomly and evenly allocated to four groups: control, SMS only, SMS plus a 75 Kenya Shilling (KES) incentive, and SMS plus 200 KES (85 KES = USD$1). Caregivers were eligible if they had a child younger than 5 weeks who had not yet received a first dose of pentavalent vaccine. Participants in the intervention groups received SMS reminders before scheduled pentavalent and measles immunisation visits. Participants in incentive groups, additionally, received money if their child was timely immunised (immunisation within 2 weeks of the due date). Caregivers and interviewers were not masked. The proportion of fully immunised children (receiving BCG, three doses of polio vaccine, three doses of pentavalent vaccine, and measles vaccine) by 12 months of age constituted the primary outcome and was analysed with log-binomial regression and General Estimating Equations to account for correlation within clusters. This trial is registered with ClinicalTrials.gov, number NCT01878435.FindingsBetween Oct 14, 2013, and Oct 17, 2014, we enrolled 2018 caregivers and their infants from 152 villages into the following four groups: control (n=489), SMS only (n=476), SMS plus 75 KES (n=562), and SMS plus 200 KES (n=491). Overall, 1375 (86%) of 1600 children who were successfully followed up achieved the primary outcome, full immunisation by 12 months of age (296 [82%] of 360 control participants, 332 [86%] of 388 SMS only participants, 383 [86%] of 446 SMS plus 75 KES participants, and 364 [90%] of 406 SMS plus 200 KES participants). Children in the SMS plus 200 KES group were significantly more likely to achieve full immunisation at 12 months of age (relative risk 1·09, 95% CI 1·02–1·16, p=0·014) than children in the control group.InterpretationIn a setting with high baseline immunisation coverage levels, SMS reminders coupled with incentives significantly improved immunisation coverage and timeliness. Given that global immunisation coverage levels have stagnated around 85%, the use of incentives might be one option to reach the remaining 15%.FundingBill & Melinda Gates Foundation.

Vaccination coverage and factors influencing routine vaccination status in 12 high risk health zones in the Province of Kinshasa City, Democratic Republic of Congo (DRC), 2015.

IntroductionVaccination coverage of the first dose of diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenza type b (pentavalent) vaccine for the City-Province of Kinshasain the years 2012 – 2014 wasbelow the national objective of 92%, with coverage less than 80% reported in 12 of the 35 health zones (HZ). The purpose of this study was to discern potential contributing factors to low vaccination coverage in Kinshasa.MethodsWe conducted a multi-stage cluster household study of children 6 – 11 months in households residing in their current neighborhood for at least 3 months in the 12 high risk HZ in Kinshasa. Additional information on vaccination status of the children was collected at the health facility.ResultsOf the 1,513 households with a child 6-11 months old, 81% were eligible and participated. Among the 1224 children surveyed, 96% had received the first dose of pentavalent vaccine; 84% had received the third dose; and 71% had received all recommended vaccines for their age. Longer travel time to get to health facility (p=0.04) and shorter length of residence in the neighborhood (p=0.04) showed significant differences in relation to incomplete vaccination. Forty percent of children received their most recent vaccination in a facility outside of their HZ of residence.ConclusionThis survey found vaccination coverage in 12 HZs in Kinshasa was higher than estimates derived from administrative reports. The large percentage of children vaccinated outside of their HZ of residence demonstrates the challenge to use of the Reaching Every District strategy in urban areas.

Reducing routine vaccination dropout rates: evaluating two interventions in three Kenyan districts, 2014.

BackgroundGlobally, vaccine preventable diseases are responsible for nearly 20 % of deaths annually among children <5 years old. Worldwide, many children dropout from the vaccination program, are vaccinated late, or incompletely vaccinated. We evaluated the impact of text messaging and sticker reminders to reduce dropouts from the vaccination program.MethodsThe evaluation was conducted in three selected districts in Kenya: Machakos, Langata and Njoro. Three health facilities were selected in each district, and randomly allocated to send text messages or provide stickers reminding parents to bring their children for second and third dose of pentavalent vaccine, or to the control group (routine reminder) with next appointment date indicated on the well-child booklet. Children aged <12 months presenting for their first dose of pentavalent vaccine were enrolled. A dropout was defined as not returning for vaccination ≥2 weeks after scheduled date for third dose of pentavalent vaccine. We calculated dropout rate as a percentage of the difference between first and third pentavalent dose.ResultsWe enrolled 1,116 children; 372 in each intervention and 372 controls between February and October 2014. Median age was 45 days old (range: 31–99 days), and 574 (51 %) were male. There were 136 (12 %) dropouts. Thirteen (4 %) children dropped out among those who received text messages, 60 (16 %) among who received sticker reminders, and 63 (17 %) among the controls. Having a caregiver with below secondary education [Odds Ratio (OR) 1.8, 95 % Confidence Interval (CI) 1.1–3.2], and residing >5 km from health facility (OR 1.6, CI 1.0–2.7) were associated with higher odds of dropping out. Those who received text messages were less likely to drop out compared to controls (OR 0.2, CI 0.04–0.8). There was no statistical difference between those who received stickers and controls (OR 0.9, CI 0.5–1.6).ConclusionText message reminders can reduce vaccination dropout rates in Kenya. We recommend the extended implementation of text message reminders in routine vaccination services.

The composition of demand for newly launched vaccines: results from the pneumococcal and rotavirus vaccine introductions in Ethiopia and Malawi.

Understanding post-launch demand for new vaccines can help countries maximize the benefits of immunization programmes. In particular, low- and middle-income countries (LMICs) should ensure adequate resource planning with regards to stock consumption and service delivery for new vaccines, whereas global suppliers must produce enough vaccines to meet demand. If a country underestimates the number of children seeking vaccination, a stock-out of commodities will create missed opportunities for saving lives. We describe the post-launch demand for the first dose of pneumococcal conjugate vaccine (PCV1) in Ethiopia and Malawi and the first dose of rotavirus vaccine (Rota1) in Malawi, with focus on the new birth cohort and the ‘backlog cohort’, comprised of older children who are still eligible for vaccination at the time of launch. PCV1 and Rota1 uptake were compared with the demand for the first dose of pentavalent vaccine (Penta1), a routine immunization that targets the same age group and immunization schedule. In the first year, the total demand for PCV1 was 37% greater than that of Penta1 in Ethiopia and 59% greater in Malawi. In the first 6 months, the demand of Rota1 was only 5.9% greater than Penta1 demand in Malawi. Over the first three post-introduction months, 70.7% of PCV1 demand in Ethiopia and 71.5% of demand in Malawi came from children in the backlog cohort, whereas only 28.0% of Rota1 demand in Malawi was from the backlog cohort. The composition of demand was impacted by time elapsed since vaccine introduction and age restrictions. Evidence suggests that countries’ plans should account for the impact of backlog demand, especially in the first 3 months post-introduction. LMICs should request for higher stock volumes when compared with routine needs, plan social mobilization activities to reach the backlog cohort and allocate human resources and cold chain capacity to accommodate high demand following vaccine introduction.

A rare side effect to pentavalent vaccine

A four month old baby experienced itchy reddish raised maculopapular lesions on face, limbs and trunk within 24 hours of immunization with booster dose of pentavalent vaccine. The lesions were not associated with fever, cough, vomiting, or insect bite. There was no similar family history with siblings .There was no history of similar reactions to the previous two doses of the same vaccine. On taking the prescribed medications the lesions subsided in 2-3 days with no recurrence at the time of follow-up.

From current vaccine recommendations to everyday practices: An analysis in five sub-Saharan African countries

BackgroundEstimates of WHO and UNICEF vaccination coverage may provide little insight into the extent to which vaccinations are administered on time. Yet, lack of adherence to the recommended age to receive a specific vaccination may have detrimental health consequences. For example, delays in receiving vaccination will prolong the risk of lack of protection, often when disease risk is highest, such as during early infancy. We estimated the reported age at vaccination, and vaccine coverage at different ages in children from five sub-Saharan African countries. MethodsWe analyzed data from the latest Demographic and Health Programme databases available for Burkina Faso 2010 (n=15,044 observations), Ghana 2008 (n=2992), Kenya 2008–9 (n=6079), Senegal 2010–11 (n=12,326), and Tanzania 2010 (n=8023). We assessed, amongst vaccinees, the exact age when vaccine was administered for the three infant doses of pentavalent vaccine (DTP) and the first dose of measles-containing-vaccine (MCV), as well as the proportion of children immunized with these antigens by a certain age. Vitamin A supplementation (VAS) coverage was evaluated as a potential contact visit for vaccine introduction. ResultsFor all DTP doses, the median intervals between recommended and actual ages of receiving vaccination ranged from 12, 17 and 23 days in Kenya, to 22, 33 and 45 days in Senegal. MCV was mostly given during the recommended age of 9 months. In each country, there was a large discrepancy in the median age at DTP vaccination between regions. VAS coverage in young children ranged from 30.3% in Kenya to 78.4% in Senegal, with large variations observed between areas within each study country. ConclusionIn the context of new vaccine introduction, age of children at vaccination should be monitored to interpret data on vaccine-preventable disease burden, vaccine effectiveness, and vaccine safety, and to adapt targeted interventions and messages.

Catching-up with pentavalent vaccine: Exploring reasons behind lower rotavirus vaccine coverage in El Salvador

Rotavirus vaccine was introduced in El Salvador in 2006 and is recommended to be given concomitantly with DTP–HepB–Haemophilus influenzae type b (pentavalent) vaccine at ages 2 months (upper age limit 15 weeks) and 4 months (upper age limit 8 months) of age. However, rotavirus vaccination coverage continues to lag behind that of pentavalent vaccine, even in years when national rotavirus vaccine stock-outs have not occurred. We analyzed factors associated with receipt of oral rotavirus vaccine among children who received at least 2 doses of pentavalent vaccine in a stratified cluster survey of children aged 24–59 months conducted in El Salvador in 2011. Vaccine doses included were documented on vaccination cards (94.4%) or in health facility records (5.6%). Logistic regression and survival analysis were used to assess factors associated with vaccination status and age at vaccination. Receipt of pentavalent vaccine by age 15 weeks was associated with rotavirus vaccination (OR: 5.1; 95% CI 2.7, 9.4), and receipt of the second pentavalent dose by age 32 weeks was associated with receipt of two rotavirus vaccine doses (OR: 5.0; 95% CI 2.1–12.3). Timely coverage with the first pentavalent vaccine dose was 88.2% in the 2007 cohort and 91.1% in the 2008 cohort (p=0.04). Children born in 2009, when a four-month national rotavirus vaccine stock-out occurred, had an older median age of receipt of rotavirus vaccine and were less likely to receive rotavirus on the same date as the same dose of pentavalent vaccine than children born in 2007 and 2008. Upper age limit recommendations for rotavirus vaccine administration contributed to suboptimal vaccination coverage. Survey data suggest that late rotavirus vaccination and co-administration with later doses of pentavalent vaccine among children born in 2009 helped increase rotavirus vaccine coverage following shortages.

Association between delayed pentavalent vaccination and immunisation drop-out in rural western Kenya: findings from a cross-sectional survey

<h2>Abstract</h2><h3>Background</h3> The identification of determinants of vaccination coverage and delays is important because these predictors identify subsets of the population that can be targeted with public health interventions. This study's aims were to determine vaccination coverage and timeliness estimates and to identify risk factors for not being vaccinated or receiving late vaccinations in rural western Kenya. <h3>Methods</h3> The study was set in 120 villages within the Kenya Medical Research Institute and Centers for Disease Control and Prevention (KEMRI/CDC) surveillance system in rural western Kenya. In March, 2013, we did a cross-sectional survey of women in the study district who had infants aged 12–23 months. We excluded data from women who did not have their child's immunisation booklet and could provide only a verbal report of their child's immunisation history. We calculated risk factors for delayed and non-receipt of immunisation using binomial regression with log link. Infants were categorised as "delayed" if immunisation was received more than 28 days from schedule. Analyses were restricted to first and third dose of pentavalent vaccine (diphtheria, tetanus, and pertussis [DTP], hepatitis B, and <i>Haemophilus influenzae</i> type b), measles vaccine, and full immunisation (BCG, three doses of polio, three doses of pentavalent, and measles vaccines). <h3>Findings</h3> We surveyed 2495 women and included data from 1748 women (70%). We excluded data from 747 women (30%) who did not have their child's immunisation booklet card present. Immunisation coverage for pentavalent 1, pentavalent 3, measles, and full immunisation were 99%, 95%, 83%, and 80%, respectively. The proportions of infants with delayed pentavalent 1, pentavalent 3, and measles immunisations were 10%, 24%, and 29%, respectively. Risk factors for not receiving vaccination and delayed vaccination were, overall, similar when estimate trends and confidence intervals were taken in to account. Specifically, infants who received pentavalent 1 late were more likely than children who had the first pentavalent vaccine within schedule to not receive pentavalent 3 (adjusted RR 5·60 [95%CI 3·75–8·37]), measles vaccine (1·47 [1·11–1·94]), and full immunisation (1·87 [1·51–2·32]). Adjusted analyses for predictors of immunisation booklet present at time of survey versus verbal report found that women living closer to the health facility, women with younger infants, and those with male infants were more likely to have an immunisation booklet present at time of survey. <h3>Interpretation</h3> Immunisation coverage for pentavalent 1, pentavalent 3, and measles vaccines was high, but many children receive their vaccinations more than 28 days after the recommended scheduled date. Since late pentavalent 1 vaccination was associated with pentavalent series drop-out, not being immunised against measles, and not being fully immunised, interventions that target infants with delayed pentavalent 1 vaccination may improve overall immunisation coverage. A potential limitation of this study was that almost a third of mothers were excluded because they could provide only a verbal report of immunisation history instead of their child's immunisation booklet. If there were substantial differences in characteristics between those with an immunisation booklet and those without, and these characteristics were associated with vaccination coverage and delay, the reported estimates may be susceptible to bias. <h3>Funding</h3> The Bill and Melinda Gates Foundation.

Cost-effectiveness of Haemophilus influenzae type b (Hib) vaccine introduction in the universal immunization schedule in Haryana State, India

In India, Haemophilus influenzae type b (Hib) vaccine introduction in the universal immunization programme requires evidence of its potential health impact and cost-effectiveness, as it is a costly vaccine. Since childhood mortality, vaccination coverage and health service utilization vary across states, the cost-effectiveness of introducing Hib vaccine was studied in Haryana state. A mathematical model was used to compare scenarios with and without Hib vaccination to estimate the cost-effectiveness of Hib vaccine in Haryana from 2010 to 2024. Demographic and National Family Health Surveys were used to estimate vaccination coverage and mortality rates among children under 5. Hib pneumonia, Hib meningitis and invasive Hib disease incidence were based on Indian studies. Vaccine and syringe prices of the UNICEF supply division were used. Cost-effectiveness from government and societal perspectives was calculated as the net incremental cost per unit of health benefit gained [disability-adjusted life years (DALYs) averted, life years saved, Hib cases averted, Hib deaths averted]. Sensitivity analysis was done using variation in parameter estimates among different states of India. The incremental cost of Hib vaccine introduction from a government and a societal perspective was estimated to be US$81.4 and US$27.5 million, respectively, from 2010 to 2024. Vaccination of 73.3, 71.6 and 67.4 million children with first, second and third dose of pentavalent vaccine, respectively, would avert 7 067 817 cases, 31 331 deaths and 994 564 DALYs. Incremental cost per DALY averted from a government (US$819) and a societal perspective (US$277) was found to be less than the per capita gross national income of India in 2009. In sensitivity analysis, Hib vaccine introduction remained cost-effective for India. Hib vaccine introduction is a cost-effective strategy in India.

Safety and Efficacy of the Pentavalent Human-Bovine (WC3) Reassortant Rotavirus Vaccine in Healthy Premature Infants

Premature infants seem to be at greater risk of hospitalization from rotavirus gastroenteritis than term infants. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine were assessed in premature infants enrolled in the large-scale, blinded, placebo-controlled rotavirus efficacy and safety trial (REST). Healthy infants 6-12 weeks of chronologic age at study entry were randomized to receive 3 oral doses of pentavalent rotavirus vaccine or placebo at 4- to 10-week intervals. Infants born at < or =36 weeks of gestational age were eligible if thriving at the time of enrollment. Safety and efficacy were retrospectively assessed in these premature infants comparing vaccine with placebo recipients. Cases of rotavirus gastroenteritis were defined as forceful vomiting and/or > or =3 watery or looser-than-normal stools within a 24-hour period, accompanied by detection of rotavirus antigen in the stool. A total of 2070 infants between 25 and 36 gestational weeks received at least 1 dose of vaccine or placebo; 1005 vaccine recipients and 1061 placebo recipients were evaluable for safety. Serious adverse events occurred in 55 vaccine recipients (5.5%) and 62 placebo recipients (5.8%). In a nested substudy of 308 premature infants evaluable for detailed safety (154 in each group), the frequencies of fever, diarrhea, vomiting, and irritability were comparable between vaccine and placebo recipients. Overall, 3 doses of the pentavalent vaccine reduced the rate of hospitalizations and emergency department visits in premature infants due to rotavirus gastroenteritis by 100% (95% CI: 82.2-100) compared with placebo. The vaccine also prevented 73.0% (95% CI: -2.2-95.2) of rotavirus gastroenteritis cases of any severity. In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.