ABSTRACT
BACKGROUND: Protecting young children from pandemic influenza should also reduce transmission to susceptible adults, including pregnant women. METHODS: An open study assessed immunogenicity and reactogenicity of a heterologous booster dose of A/turkey/Turkey/1/2005(H5N1)-AS03B (AS03B is an Adjuvant System containing α-tocopherol and squalene in an oil-in-water emulsion [5.93 mg tocopherol]) in infants and children aged 6 to <36 months that was given 6 months following 2-dose primary vaccination with A/Indonesia/05/2005(H5N1)-AS03B. Vaccines contained 1.9 µg of hemagglutinin antigen and AS03B. Hemagglutinin inhibition (HI) responses, microneutralization titers, and antineuraminidase antibody levels were assessed for 6 months following the booster vaccination. RESULTS: For each age stratum (defined on the basis of the subject's age at first vaccination as 6 to <12 months, 12 to <24 months, and 24 to <36 months) and overall (n=113), European influenza vaccine licensure criteria were fulfilled for responses to A/turkey/Turkey/1/2005(H5N1) 10 days following the booster vaccination. Local pain and fever increased with consecutive doses. Anamnestic immune responses were demonstrated for HI, neutralizing, and antineuraminidase antibodies against vaccine-homologous/heterologous strains. Antibody responses to vaccine-homologous/heterologous strains persisted in all children 6 months following the booster vaccination. CONCLUSIONS: Prevaccination of young children with a clade 2 strain influenza A(H5N1) AS03-adjuvanted vaccine followed by heterologous booster vaccination boosted immune responses to the homologous strain and a related clade, with persistence for at least 6 months. The results support a prime-boost vaccination approach in young children for pandemic influenza preparedness. CLINICAL TRIALS REGISTRATION: NCT01323946.
Subject(s)
Adjuvants, Immunologic/administration & dosage , Influenza A Virus, H5N1 Subtype/immunology , Influenza Vaccines/immunology , Influenza, Human/prevention & control , Antibodies, Viral/immunology , Child, Preschool , Female , Hemagglutination Inhibition Tests , Humans , Immunization, Secondary , Infant , Influenza Vaccines/administration & dosage , Influenza Vaccines/adverse effects , Male , Singapore/epidemiology , VaccinationABSTRACT
BACKGROUND: The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed. METHODS: In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA. RESULTS: Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ≥93.6% and ≥88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ≥0.2 µg/mL and OPA titres ≥8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ≥60.8% and ≥98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ≥0.2 µg/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ≤11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study. CONCLUSIONS: PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625.
Subject(s)
Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/administration & dosage , Streptococcus pneumoniae/immunology , Vaccination , Vaccines, Conjugate/administration & dosage , Antibodies, Bacterial/blood , Antibodies, Bacterial/immunology , Bacterial Proteins/administration & dosage , Carrier Proteins/administration & dosage , Female , Humans , Immunization, Secondary , Immunoglobulin D/administration & dosage , Immunoglobulin D/blood , Infant , Lipoproteins/administration & dosage , Malaysia , Male , Polysaccharides, Bacterial/immunology , Singapore , Vaccine PotencyABSTRACT
This study examined children's adherence to the Singapore Integrated 24-Hour Activity Guidelines for Early Childhood in infants, toddlers and preschoolers aged 0-6 years. A total of 901 caregivers, comprising 219 infants, 379 toddlers, and 303 preschoolers, provided information regarding their children's physical activity (PA), screen viewing time (SVT), and sleep durations on both weekdays and weekends. Meeting the 24-hour integrated activity guidelines was defined as follows: for infants ≥ 30 minutes per day of tummy time or floor-based play; zero SVT; total sleep of 14-17 hours per day for ages 0-3 months, 12-16 hours per day for ages 4-11 months; for toddlers ≥ 180 minutes of total PA per day; zero SVT under 2 years; <1 hour for ages 2 to less than 3 years; and a total sleep of 11-14 hours per day; for preschoolers ≥ 180 minutes of total PA per day; SVT <1 hour per day; total sleep of 10-13 hours per day for those aged 3-5 years, and 10-11 hours per day for 6-year-olds. Chi-squared tests were used to examine the differences in guideline adherence between weekdays and weekends. Compared to weekdays, during weekends there was a higher proportion of toddlers and preschoolers adhering to the PA guidelines (68.9% vs 50.1%; 78.9% vs 55.4%, respectively, p<0.05), and a lower proportion of toddlers adhering to SVT (38.8% vs 21.8%; p = 0.001). There was a declining adherence to all three activity guidelines as age groups progressed from infants (44.7%) to toddlers (15.8%) and then to preschoolers (9.4%). Concurrently, there was a decrease in adherence to SVT recommendations across the age groups, with adherence rates being highest among infants (83.1%), followed by toddlers (15.8%), and preschoolers (9.4%). Decreasing compliance with all three guidelines, coupled with a corresponding decline in adherence to SVT guidelines as children transition from toddlerhood to preschool age, is a cause for concern. This underscores the need for proactive efforts to educate caregivers about reducing or eliminating SVT among infants and young children.
Subject(s)
Exercise , Sleep , Infant , Humans , Child, Preschool , Child , Singapore , Educational Status , Guideline AdherenceABSTRACT
This study aimed to examine the prevalence of adherence to 24 h activity guidelines in children and adolescents from Asia-Pacific cities. In 1139 children aged 5-18 years, moderate-to-vigorous physical activity (MVPA), screen viewing time (SVT), sleep duration, child weight, height, sex, and age were parent-reported. Descriptive statistics were used to assess the number of guidelines met, and prevalence of adherence to activity guidelines by city and child sex. Prevalence of meeting all three 24 h activity guidelines was low across all countries (1.8-10.3%) (p < 0.05). Children from Thiruvananthapuram, India had the highest [10.3% (95% CI: 6.0-17.0)], while those from Tokyo, Japan had the lowest prevalence [1.8% (95% CI: 0.5-7.0)] of meeting all three guidelines. The highest prevalence of meeting individual MVPA, SVT and sleep guidelines was found in India [67.5% (95% CI: 58.8-75.1)], Kelaniya, Sri Lanka [63.2% (95% CI: 58.7-67.4)] and Kowloon, Hong Kong [59.4% (95% CI: 51.1-65.3)], respectively. Overall, a higher prevalence of boys met all three guidelines, compared to girls [5.9% (95% CI: 4.1-8.1) vs. 4.7% (3.1-6.6), p = 0.32]. The prevalence of adhering to all three activity guidelines was low in all five participating cities, with a higher proportion of boys meeting all guidelines.
Subject(s)
Sedentary Behavior , Sleep , Male , Female , Humans , Child , Adolescent , Cities , Prevalence , Surveys and Questionnaires , Hong KongABSTRACT
Introduction: Early childhood is a critical period for growth and development. Adopting healthy lifestyle behaviours during this period forms the foundation for future well-being and offers the best protection against non-communicable diseases. Singapore studies have shown that many young children are not achieving the recommendations on physical activity, sedentary behaviour and sleep. A workgroup was set up to develop recommendations for caregivers of infants, toddlers and preschoolers (aged <7 years) on how to integrate beneficial activities within a daily 24-hour period for optimal development and metabolic health. Method: The Grading of Recommendations Assessment, Development and Evaluation (GRADE)- ADOLOPMENT approach was employed for adoption, adaption or de novo development of recommendations. International and national guidelines were used as references, and an update of the literature reviews up to September 2021 was conducted through an electronic search of PubMed, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Results: Four consensus statements were developed for each age group: infants, toddlers and preschoolers. The statements focus on achieving good metabolic health through regular physical activity, limiting sedentary behaviour, achieving adequate sleep and positive eating habits. The 13th consensus statement recognises that integration of these activities within a 24-hour period can help obtain the best results. Conclusion: This set of recommendations guides and encourages caregivers of Singapore infants, toddlers and preschoolers to adopt beneficial lifestyle activities within each 24-hour period.
Subject(s)
Consensus , Exercise , Sedentary Behavior , Sleep , Child, Preschool , Humans , Infant , Exercise/physiology , Feeding Behavior , Healthy Lifestyle , Singapore , Sleep/physiology , ChildABSTRACT
INTRODUCTION: Lifestyle activities, such as regular physical activity, are important for good metabolic health and the prevention of non-communicable diseases. Epidemiological studies highlight an increase in the proportion of overweight children in Singapore. A workgroup was formed to develop recommendations to encourage children and adolescents (aged 7-17 years) to adopt a holistic approach towards integrating beneficial activities within a daily 24-hour period for good metabolic and general health. METHODS: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision framework was employed to formulate the public health question, assess the evidence and draw conclusions for the guide. The evidence for international 24-hour movement guidelines, and guidelines for physical activity, sedentary behaviour, and sleep and eating habits were reviewed. An update of the literature review from August 2018 to end of September 2020 was conducted through an electronic search of Medline and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases. RESULTS: Ten consensus statements were developed. The statements focused on the overall aim of achieving good metabolic health through integration of these activities and initiatives: light and moderate- to vigorous-intensity physical activity on a regular basis; muscle- and bone-strengthening activities; limiting sedentary behaviour; regular and adequate sleep; good eating habits and choosing nutritionally balanced foods and drinks; practise safety in exercise; and aiming to achieve more or all aforementioned recommendations for the best results. CONCLUSION: This set of recommendations provides guidance to encourage Singapore children and adolescents to adopt health-beneficial activities within a 24-hour period.
Subject(s)
Exercise , Sedentary Behavior , Adolescent , Child , Humans , Public Health , Singapore , SleepABSTRACT
Infantile colic is a common self-limiting condition that causes significant distress to parents and caregivers. There is no clear cause, gold standard remedy or preventative action. The role of the family physician is to rule out sinister causes while providing counselling and reassurance for parents. The mainstay of management is parental support and reassurance while looking out for red flags in the baby such as fever, lethargy, distended abdomen and failure to thrive. This article provides a framework to approaching infantile colic and practical pointers to share with parents.
Subject(s)
Colic/diagnosis , Colic/therapy , Pediatrics/methods , Primary Health Care/methods , Caregivers , Crying , Evidence-Based Medicine , Humans , Infant , Infant Formula , Infant, Newborn , Muscle Hypertonia/diagnosis , Parenting , Parents , Physicians, Family , Professional-Patient RelationsABSTRACT
AIM: This study evaluated the immunogenicity and safety of tetravalent measles-mumps-rubella-varicella (MMRV) vaccine produced with measles and rubella monovalent bulks derived from a newly established working seed virus stock (MMRV(new WS)) compared with the combined MMRV vaccine derived from the current seed virus stock, in Taiwanese and Singaporean children (NCT00892775). METHODS: Healthy children aged 11-22 mo were randomized to receive two doses of either the MMRV(new WS) vaccine or the MMRV vaccine. Antibody titers against measles, mumps and rubella were measured using ELISA and against varicella using an immunofluorescence assay. The primary objective was to demonstrate non-inferiority of MMRV(new WS) to MMRV in terms of post-dose-1 seroconversion rates, defined as a group difference with a lower limit of the 95% confidence interval greater than -10% for each antigen. Parents/guardians recorded symptoms in diary cards for 43 d after each vaccine dose. RESULTS: Non-inferiority of MMRV(new WS) to MMRV was achieved for all vaccine antigens. The lower limits of the 95% confidence intervals for group differences (MMRV(new WS) group vs. MMRV) for measles (99.4% vs 100%), mumps (89.7% vs 90.4%), rubella (99.7% vs 100%) and varicella (97.6% vs 92.9%) seroconversion rates were greater than -10%. Mild symptoms including a peak in fever between days 5 and 12, post-dose-1, was observed in both groups. CONCLUSION: The immune responses elicited by the MMRV(new WS) vaccine were non-inferior to that elicited by the MMRV vaccine for all antigens. Both vaccines exhibited an acceptable safety profile in Taiwanese and Singaporean children.