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In 2019, the RTS,S/AS01Twenty-one in-depth interviews were conducted with regional and district health service managers and frontline health workers three months after the start of MVIP in May 2019. Data were coded using NVivo software version 12 and a coding framework was developed to support thematic analysis to identify the challenges and lessons learned during the RTS,S/AS01Participants reported challenges related to the characteristics of the intervention, such as issues with the vaccine schedule and eligibility criteria, and challenges related to how it was implemented as a pilot programme. Additionally, major challenges were faced due to the spread of rumours leading to vaccine refusals; thus, the outer setting of the CFIR was adapted to accommodate rumours within the community context. Health service managers and frontline health workers also experienced challenges with the process of implementing RTS,S/AS01This study identified 12 main challenges and lessons learned by health service managers and health workers during the planning and early implementation phases of the RTS,S/AS01

Sub-Saharan African pre-school children have an interdependence among immune response, infection resistance and adaptive effect of the dietary intake. However, the long hinge region of immunoglobulin G3 makes binding easy to malaria antigens and receptors, eliciting a more protective response among subclasses of immunoglobulin G. However, it is unknown if iron-containing multimicronutrients are associated with risk of anaemia and malaria in pre-school children with hinge region G3 immunoglobulin polymorphism living in high malaria transmission areas. We aimed to determine the impact of iron fortification in pre- chool children with immunoglobulin G3 hinge region length polymorphisms and their associated risk of malaria and anaemia in rural Ghana. This retrospective controlled, double blind, randomized population study was conducted over six months in rural Ghana among 6 to 35-month-old infants and young children. Participants were randomly allocated either ironfree multimicronutrients powder (placebo group) or iron (intervention group; 12.5 mg iron daily) into clusters where mixed semi-liquid homemade meals were delivered daily for 5 months. Anti-malaria mosquito bed nets and anti-malaria treatment were readily available during the study. Standardized therapeutic and epidemiological questionnaires were administered. Participants’ blood samples were assessed for immunoglobulin G3 hinge region length polymorphism, full blood count, anthropometry, and malaria microscopy. Baseline anthropometry, anaemia, iron status, demographic characteristics and dietary consumption were similar (p > 0.05). 27.85 % were venerable to clinical malaria at baseline. Homozygote medium polymorphism had the maximum frequency of 48 %, followed by homozygote long polymorphism (43 %), heterozygote long-medium polymorphisms (7.0 %) and relatively few were homozygote short 2.0 % with similarities between the study groups (p = 0.14; HardyWeinberg equilibrium estimate, χ2 analysis). However, iron fortification did not influence the risk of aneamia and malaria among participants with immunoglobulin G3 hinge region length polymorphisms but was not detrimental to participants.

Background Iron fortification and micronutrient initiatives, specifically, vitamin A, and zinc supplementation are the most cost-effective developmental strategies against malnutrition and health emergencies in pre-school children. Iron-deficiency among pre-school children have been documented, however, studies evaluating the impact of immunoglobulin G (IgG) isotype responses among iron-fortified pre-school children in malaria endemic communities has not been assessed. We evaluated the impact of iron fortification on the IgG responses to GLURP R0, GLURP R2 and MSP3 FVO malaria-specific antigens among pre-school children in malaria endemic areas. Methods This community-based, placebo-controlled, double-blinded, cluster-randomized trial study was conducted in Wenchi Municipal and Tain District of Bono Region. The trial was registered at ClinicalTrials.gov-registered trial (Identifier: NCT01001871). Ethical approval was obtained and informed consent were sought from each participant parents/guardian. For the current objective, 871 children aged 6–35 months were screened, from which 435 children received semi-liquid home-made meals mixed with 12.5 mg of iron daily (intervention group), and 436 received micronutrient powder without iron (placebo group) for 5 months. Standardized clinical and epidemiological questionnaires were administered and blood samples taken to measure IgG responses to GLURP R0, GLURP R2 and MSP3 FVO recombinant antigens using the Afro Immunoassay (AIA) protocol. Results Baseline anthropometry, malaria diagnosis, anaemia and iron status, demographic features and dietary intake were identical among the groups (p > 0.05). After the intervention, there was no significant difference in the IgG response against GLUP R0, GLUP R2 and MSP3 FVO between the iron-containing micronutrient and placebo groups (p > 0.05). The iron-containing micronutrient powder group who were iron-sufficient or iron replete had significantly higher IgG response to GLURP R0 and GLURP R2 compared to iron-deficient and iron-deficiency anaemia in the same group (p < 0.05). The IgG responses to all the three malaria specific antigens were low among children without malaria episode but high among those with two and four episodes due to exposure differences. Conclusion Iron fortification did not influence antibody response against endogenous malaria specific antigens among pre-school children in malaria endemic areas, however, IgG response to malaria specific antigens were high among children with sufficient iron status.

Background Micronutrient interventions, principally vitamin A and zinc supplementation for children, and fortification of foods with iron and iodine, are considered the most cost-effective global development efforts. Multiple micronutrient powder is a mixture of at least iron, zinc and vitamin A used to prevent malnutrition in children and during health emergencies. Micronutrient deficiencies are a universal health burden among young children in developing countries. However, the use of this low cost but sustainable micronutrient powder as an innovative home-fortification approach to control a common nutritional disorder like iron deficiency anaemia among pre-school children living in malaria endemic sub-Saharan Africa is unclear. The aim of our study was to determine the effect of providing long-term continued prophylactic micronutrient powder with iron on the risk of iron deficiency and anaemia among pre-school children living in rural Ghana.Methods This population-based randomized-cluster trial was conducted in the Bono region of Ghana from 3rd April to 6th July 2010. 1958 children were recruited, and 967 randomly assigned to receive prophylactic micronutrient powder with iron and 991 assigned to receive placebo. The trial participants were children aged between 6 to 35 months, identified at home and able to eat semi-solid foods (with or without breast milk). Structured questionnaires were administered, their blood samples were also taken for biochemical analysis. They were randomly assigned to receive daily micronutrient powder without or with iron (12·5 mg) added to complementary meals immediately after enrollment for five months. Each participant also received anti-malaria treated bednet and chemotherapy. Weekly follow up visits were conducted at home or health facility where data on malaria using rapid diagnostic test and hospital admissions were collected. The primary outcome was post supplementation of prophylactic micronutrient powder with iron to mitigate the effects of iron deficiency and anaemia.Results 1958 children were recruited and 967 randomly assigned to receive prophylactic micronutrient powder with iron and 991 assigned to receive placebo. Loss to follow up was 7 % (143), with vital status at 35 months of age reported for 1904 (97.2 %). Anthropometry, anaemia, iron status, demographic characteristics and dietary intakes were similar between the groups at baseline. Baseline haemoglobin level was significantly higher compared to haemoglobin level at endline (p < 0.0001). Though, we recorded an increase in haemoglobin (p = 0.0001) and ferritin (p = 0.0002) levels in the iron group than in the placebo group at the end of the intervention. Soluble transferrin receptor levels were more saturated among children from the iron group compared to placebo group (p = 0.012). Anaemic status in the iron group improved compared to the non-iron group (p = 0.03).Conclusion The risk of childhood morbidity and mortality in rural Ghana is high, mainly due to iron deficiency anaemia. National nutritional policy coupled with the current WHO recommendations are required to support the provision of prophylactic micronutrient powder with iron in order to improve anaemic and iron status among pre-school children in rural Ghana.TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01001871. Registered 27th October 2009, http://www. ClinicalTrials.gov/ NCT01001871

AIM To systematically review the effectiveness of education and/or training for traditional (informal) and formal health service providers in infant male circumcision on morbidity or mortality outcomes. METHODS We searched Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, Global Health, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects and clinical trial registries in all languages from January 1985 to June 2018. Our primary outcomes were all-cause morbidity and all-cause mortality. RESULTS We identified 1399 publications. Only four non-controlled before and after studies from the USA and Uganda satisfied our criteria, all of which examined the effect of training on the skills and knowledge of medical doctors, midwives and clinical officers. No study involved informal traditional circumcision providers. All included studies were low quality. CONCLUSIONS High-quality studies of simple training packages to improve education and training of circumcision providers, especially informal non-medical providers in low income countries are needed.

REVIEW QUESTION/OBJECTIVE The objective of this review is to synthesize the best available evidence on the effectiveness of population based (public health) risk reduction interventions (programs and services) on sexual risk taking among young people (aged 10 to 24 years old) in low- and middle-income countries (LMICs).The specific review questions are.

OBJECTIVE Male circumcision services have expanded throughout Africa as part of a long-term HIV prevention strategy. We assessed the effect of type of service provider (formal and informal) and hygiene practices on circumcision-related morbidities in rural Ghana. METHODS Population-based, cross-sectional study conducted between May and December 2012 involving 2850 circumcised infant males aged under 12 weeks. Multivariable logistic regression models were adjusted for maternal age, maternal education, income, birthweight and site of circumcision. RESULTS A total of 2850 (90.7%) infant males were circumcised. Overall, the risk of experiencing a morbidity (defined as complications occurring during or after the circumcision procedure as reported by the primary caregiver) was 8.1% (230). Risk was not significantly increased if the circumcision was performed by informal providers (121, 7.2%) vs. formal health service providers (109, 9.8%) [adjusted odds ratio (aOR) 1.11, 95% CI 0.80-1.47, P = 0.456]. Poor hygiene practices were associated with significantly increased risk of morbidity: no handwashing [148 (11.7%)] (aOR 1.78, 95% CI 1.27-2.52, P = 0.001); not cleaning circumcision instruments [174 (10.6%)] (aOR 1.80, 95% CI 1.27-2.54, P = 0.001); and uncleaned penile area [190 (10.0%)] (aOR 1.84, 95% CI 1.25-2.70, P = 0.002). CONCLUSION The risk of morbidity after infant male circumcision in rural Ghana is high, chiefly due to poor hygiene practices. Governmental and non-governmental organisations need to improve training of circumcision providers in hygiene practices in sub-Saharan Africa.

Review Questions/Objectives The objective of this review is to synthesise the best available evidence on the effectiveness of population based (public health) risk reduction programs and services (interventions) on sexual and reproductive health risk taking among young people (aged 10 to 24 years old) in developing countries (countries with low and middle gross national income (GNI) per capita as defined by World Bank). The specific review questions are: 1. What is the effectiveness of population based (public health) risk reduction programs and services (interventions) on risky sexual behaviors among young people? 2. What are the characteristics of population based interventions that are effective in reducing risky behaviors among young people? 3. What specific outcome measures best assess the impact of interventions that effectively reduce sexual risk taking among adolescents in developing countries? Inclusion Criteria a. Types of Participants The review will consider individuals of ages 10 to 24 years residing in developing countries. b. Types of interventions The review will consider population based (public health) risk reduction programs and services that target young people in developing countries. c. Types of Outcomes Anticipated outcomes related to reduction in risky sexual behavior among young people include the following: Primary outcomes: Abstinence rates, rates of early/premarital sexual initiation, numbers of sexual partners, condom use at first sex, consistent and correct contraceptive (condom) use during sexual encounters among the study population, alcohol and/or substance use prior to or during sexual encounters (short term outcomes). Secondary outcomes: Pregnancies and their outcomes including rates of abortion, births (live and still), etc., STI rates, HIV/AIDS rates, maternal mortality and educational attainment levels of adolescents in the study population (Long term outcomes).

Background There has been an expansion of circumcision services in Africa as part of a long-term HIV prevention strategy. However, the effect of infant male circumcision on morbidity and mortality still remains unclear. Acute morbidities associated with circumcision include pain, bleeding, swelling, infection, tetanus or inadequate skin removal. Scale-up of circumcision services could lead to a rise in these associated morbidities that could have significant impact on health service delivery and the safety of infants. Multidisciplinary training programmes have been developed to improve skills of health service providers, but very little is known about the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. This review aims to evaluate the effectiveness of health service provider education and/or training for infant male circumcision on short- and long-term morbidity outcomes. Methods/design The review will include studies comparing health service providers who have received education and/or training to improve their skills for infant male circumcision with those who have not received education and/or training. Randomised controlled trials (RCTs) and cluster RCTs will be included. The outcomes of interest are short-term morbidities of the male infant including pain, infection, tetanus, bleeding, excess skin removal, glans amputation and fistula. Long-term morbidities include urinary tract infection (UTI), HIV infection and abnormalities of urination. Databases such as MEDLINE (OVID), PsycINFO (OVID), EMBASE (OVID), CINAHL, Cochrane Library (including CENTRAL and DARE), WHO databases and reference list of papers will be searched for relevant articles. Study selection, data extraction and synthesis and risk of bias assessment using the Cochrane risk of bias assessment tool will be conducted. We will calculate the pooled estimates of the difference in means and risk ratios using random effects models. If insufficient data are available, we will present results descriptively. Discussion This review appears to be the first to be conducted in this area. The findings will have important implications for infant male circumcision programmes and policy. Systematic review registration PROSPERO CRD42015029345 Electronic supplementary material The online version of this article (doi:10.1186/s13643-016-0216-6) contains supplementary material, which is available to authorized users.

Objectives To evaluate the impact of Newhints community-based surveillance volunteer (CBSV) assessments and referrals on access to care for sick newborns and on existing inequities in access. Design We evaluated a prospective cohort nested within the Newhints cluster-randomised controlled trial. Setting Community-based intervention involving more than 750 000, predominantly rural, population in seven contiguous districts in the Brong-Ahafo Region, Ghana. Participants Participants were recently delivered women (from more than 120 000 women under surveillance) and their 16 168 liveborn babies. Qualitative in-depth interviews with referral narratives (IDIs) were conducted with 92 mothers, CBSVs and health facility front-desk and maternity/paediatrics ward staff. Interventions Newhints trained and effectively supervised 475 CBSVs (existing within the Ghana Health Service) in 49 of 98 supervisory zones (clusters) to assess and refer newborns with any of the 10-key-danger signs to health facilities within the first week after birth; promote independent care seeking for sick newborns and problem-solve around barriers between November 2008 and December 2009. Primary outcomes The main evaluation outcomes were rates of compliance with referrals and independent care seeking for newborn illnesses. Results Of 4006 sampled, 2795 (69.8%) recently delivered women received CBSV assessment visits and 279 (10.0%) newborns were referred with danger signs. Compliance with referrals was unprecedentedly high (86.0%) with women in the poorest quintile (Q1) complying better than the least poor (Q5):87.5%(Q1) vs 69.7%(Q5); p=0.038. Three-quarters went to hospitals; 18% were admitted and 58% received outpatient treatment. Some (24%) mothers were turned away at facilities and follow-on IDIs showed that some of these untreated babies subsequently died. Independent care seeking for severe newborn illness increased from 55.4% in control to 77.3% in Newhints zones, especially among Q1 where care seeking almost doubled (95.0% vs 48.6%; RR=1.94 (1.32, 2.84); p=0.001). Rates were the highest among rural residents but urban residents complied quicker. Conclusions Home visits are feasible and a potentially pro-poor approach to link sick newborns to facilities. Its effectiveness in improving survival hinges on matched improvement in facility quality of care. Trial registration number NCT00623337.

ObjectiveThis study assessed healthcare seeking patterns of families of infants with circumcision-related morbidities and families of infants with acute illnesses in rural Ghana.DesignTwo population-based cohort studies.SettingBrong Ahafo Region of central rural Ghana.ParticipantsA total of 22 955 infants enrolled in a large population-based trial (Neovita trial) from 16 August 2010 to 7 November 2011 and 3141 infants in a circumcision study from 21 May 2012 to 31 December 2012.Primary outcomeCare seeking for circumcision-related morbidities and acute illnesses unrelated to circumcision.ResultsTwo hundred and thirty (8.1%) infants from the circumcision study had circumcision-related morbidities and 6265 (27.3%) infants from the Neovita study had acute illnesses unrelated to circumcision. A much lower proportion (35, 15.2%) of families of infants with circumcision-related morbidities sought healthcare compared with families of infants with acute illnesses in the Neovita study (5520, 88.1%). More families sought care from formal providers (24, 69%) compared with informal providers (11, 31%) for circumcision-related morbidities. There were no obvious determinants of care seeking for acute illnesses or circumcision-related morbidities in the population.ConclusionsGovernment and non-government organisations need to improve awareness about the complications and care seeking needed for circumcision-related morbidities.

A World Health Organization (WHO)/United Nations Children's Fund (UNICEF) (2009) joint statement recommended home visits by community-based agents as a strategy to improve newborn survival, based on promising results from Asia. This article presents detailed evaluation of community volunteer assessment and referral implemented within the Ghana Newhints home visits cluster-Randomized Controlled Trial (RCT). It highlights the lessons learned to inform implementation/scale-up of this model in similar settings. The evaluation used a conceptual framework adopted for increasing access to care for sick newborns and involves three main steps, each with a specific goal and key requirements to achieving this. These steps are: sick newborns are identified within communities and referred; families comply with referrals and referred babies receive appropriate management at health facilities. Evaluation data included interviews with 4006 recently delivered mothers; records on 759 directly observed volunteer assessments and 52 validation of supervisors' assessments; newborn care quality assessment in 86 health facilities and in-depth interviews (IDIs) with 55 mothers, 21 volunteers and 15 health professionals. Assessment accuracy of volunteers against supervisors and physician was assessed using Kappa (agreement coefficient). IDIs were analysed by generating and indexing into themes, and exploring relationships between themes and their contextual interpretations. This evaluation demonstrated that identifying, understanding and implementing the key requirements for success in each step of volunteer assessment and referrals was pivotal to success. In Newhints, volunteers (CBSVs) were trusted by families, their visits were acceptable and they engaged mothers/families in decisions, resulting in unprecedented 86% referral compliance and increased (55-77%) care seeking for sick newborns. Poor facility care quality, characterized by poor health worker attitudes, limited the mortality reduction. The important implication for future implementation of home visits in similar settings is that, with 100% specificity but 80% sensitivity of referral decisions, volunteers might miss some danger signs but if successful implementation must translate into mortality reductions, concurrent improvement in facility newborn care quality is imperative.

In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p

Background Tackling neonatal mortality is essential for the achievement of the child survival millennium development goal. There are just under 4 million neonatal deaths, accounting for 38% of the 10.8 million deaths among children younger than 5 years of age taking place each year; 99% of these occur in low- and middle-income countries where a large proportion of births take place at home, and where postnatal care for mothers and neonates is either not available or is of poor quality. WHO and UNICEF have issued a joint statement calling for governments to implement "Home visits for the newborn child: a strategy to improve survival", following several studies in South Asia which achieved substantial reductions in neonatal mortality through community-based approaches. However, their feasibility and effectiveness have not yet been evaluated in Africa. The Newhints study aims to do this in Ghana and to develop a feasible and sustainable community-based approach to improve newborn care practices, and by so doing improve neonatal survival. Methods Newhints is an integrated intervention package based on extensive formative research, and developed in close collaboration with seven District Health Management Teams (DHMTs) in Brong Ahafo Region. The core component is training the existing community based surveillance volunteers (CBSVs) to identify pregnant women and to conduct two home visits during pregnancy and three in the first week of life to address essential care practices, and to assess and refer very low birth weight and sick babies. CBSVs are supported by a set of materials, regular supervisory visits, incentives, sensitisation activities with TBAs, health facility staff and communities, and providing training for essential newborn care in health facilities. Newhints is being evaluated through a cluster randomised controlled trial, and intention to treat analyses. The clusters are 98 supervisory zones; 49 have been randomised for implementation of the Newhints intervention, with the other 49 acting as controls. Data on neonatal mortality and care practices will be collected from approximately 15,000 babies through surveillance of women of child-bearing age in the 7 districts. Detailed process, cost and cost-effectiveness evaluations are also being carried out. Trial registration http://www.clinicaltrials.gov (identifier NCT00623337)

Formative research is often used to inform intervention design, but the design process is rarely reported. This study describes how an integrated home visit intervention for newborns in Ghana was designed. As a first step in the design process, the known intervention parameters were listed, information required to refine the intervention was then identified and a formative research strategy designed. The strategy included synthesizing available data, collecting data on newborn care practices in homes and facilities, on barriers and facilitators to adopting desired behaviors and on practical issues such as whom to include in the intervention. The data were used to develop an intervention plan through workshops with national and international stakeholders and experts. The intervention plan was operationalized by district level committees. This included developing work plans, a creative brief for the materials and completing a community volunteer inventory. The intervention was then piloted and the intervention materials were finalized. The design process took over a year and was iterative. Throughout the process, literature was reviewed to identify the best practice. The intervention focuses on birth preparedness, using treated bednets in pregnancy, early and exclusive breastfeeding, thermal care, special care for small babies and prompt care seeking for newborns with danger signs. The need for a problem-solving approach was identified to help ensure behavior change. A subset of behaviors were already being performed adequately, or were the focus of other interventions, but were important to reinforce in the visits. These include attending antenatal care and care seeking for danger signs in pregnancy. On the basis of the intervention content, the timing of newborn deaths and the acceptability of visits, two antenatal and three visits in the first week of life (days 1, 3 and 7) were planned. Several household members were identified to include in the visits as they were involved in newborn care or they made financial decisions. Birth attendants and health workers were often the locus of control for immediate newborn care, and sensitization activities were designed to improve their practices and to help ensure that families received consistent messages. An existing cadre of community volunteers was identified to deliver the intervention-these volunteers were already trusted and accepted by the community, already visited pregnant women at home and had the time and commitment to deliver the intervention. A supervision and remuneration system was developed through discussions with the volunteers and at the planning workshops. The need for community entry activities was identified to garner community support for the intervention, to encourage self-identification of pregnant and delivered women and to motivate the volunteer through community recognition. Formative research is an essential step in helping to ensure the development of an effective, appropriate and sustainable intervention.

The Expanded Programme on Immunisation provides an opportunity to deliver vitamin A supplements to young infants in order to improve their vitamin A status. However, concerns have been raised about the safety of administering high dose vitamin A supplements to infants less than 6 months of age in developing countries. A randomized controlled trial was carried out by the Kintampo Health Research Centre to assess the safety and immunogenicity of administering 15 mg retinol equivalent (RE)1 vitamin A alongside the pentavalent "diphtheria-polio-tetanus-Haemophilus influenzae b-hepatitis B vaccine" at 6, 10 and 14 weeks of age. All mothers received a post-partum supplement of 120 mg RE vitamin A as per national policy. Mothers of infants who had been vaccinated were visited 24 h after vaccination to assess the side effects of the vaccine. They were also interviewed about adverse events which may have occurred in the past 4 weeks since the child was vaccinated. There were significantly fewer reports of illnesses and fever in infants who had been given vitamin A compared to infants in the control group. The pentavalent vaccine was found to be tolerable when administered with vitamin A according to the WHO/EPI schedule for infant immunisation at 6, 10 and 14 weeks. There were few complaints made by the mothers of the children which were not thought to be related to giving vitamin A with the vaccines. There were six deaths in the trial, five in the intervention group and one in the control RR 4.65 (0.55-39.5), p = 0.12. Due to the high point estimate of 4.65, we wish to urge caution in administering high doses of vitamin A to young infants with the pentavalent vaccine at 6, 10 and 14 weeks of age.