A phase II/III randomised, comparative study evaluating the safety and immunogenicity of Biological E's live, attenuated Measles-Rubella vaccine in 9–12 month old healthy infants
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PROVIDER: S-EPMC10696430 | biostudies-literature | 2023 Nov
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Project description:Early life nutrition and feeding practices are important modifiable determinants of subsequent obesity, yet little is known about the circadian feeding pattern of 12-month-old infants. We aimed to describe the 24-h feeding patterns of 12-month-old infants and examine their associations with maternal and infant characteristics. Mothers from a prospective birth cohort study (n 431) reported dietary intakes of their 12-month-old infants and respective feeding times using 24-h dietary recall. Based on their feeding times, infants were classified into post-midnight (00.00-05.59 hours) and pre-midnight (06.00-23.59 hours) feeders. Mean daily energy intake was 3234 (sd 950) kJ (773 (sd 227) kcal), comprising 51·8 (sd 7·8) % carbohydrate, 33·9 (sd 7·2) % fat and 14·4 (sd 3·2) % protein. Mean hourly energy intake and proportion of infants fed were lower during post-midnight than pre-midnight hours. There were 251 (58·2 %) pre-midnight and 180 (41·8 %) post-midnight feeders. Post-midnight feeders consumed higher daily energy, carbohydrate, fat and protein intakes than pre-midnight feeders (all P<0·001). The difference in energy intake originated from energy content consumed during the post-midnight period. Majority (n 173) of post-midnight feeders consumed formula milk during the post-midnight period. Using multivariate logistic regression with confounder adjustment, exclusively breast-feeding during the first 6 months of life was negatively associated with post-midnight feeding at 12 months (adjusted OR 0·31; 95 % CI 0·11, 0·82). This study provides new insights into the circadian pattern of energy intake during infancy. Our findings indicated that the timing of feeding at 12 months was associated with daily energy and macronutrient intakes, and feeding mode during early infancy.
| S-EPMC5564492 | biostudies-literature
Project description:This open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2; n=323) VAQTA™ (25U/0.5 mL) (hepatitis A vaccine; HAV) with ProQuad™ (measles/mumps/rubella/varicella; MMRV) and Prevnar™ (7-valent pneumococcal; PCV-7) in healthy, 12-23 mo old children. Group 1 received HAV/MMRV/PCV-7 concomitantly on Day 1 and second doses of HAV/MMRV at Week 24. Group 2 received MMRV/PCV-7 on Day 1, HAV at Weeks 6 and 30 and MMRV at Week 34. Hepatitis A seropositivity rate (SPR: ≥10 mIU/mL; 4 weeks postdose 2), varicella zoster-virus (VZV) SPR (≥5 gpELISA units/mL) and geometric mean titers (GMT) to S. pneumoniae were examined. Injection-site and systemic adverse experiences (AEs) and daily temperatures were collected. Hepatitis A SPR were 100% for Group 1 and 99.4% for Group 2 after two HAV doses; risk difference=0.7 (95%CI: -1.4,3.8, non-inferior) regardless of initial serostatus. VZV SPR was 93.3% for Group 1 and 98.3% for Group 2; risk difference=-5.1 (95%CI: -9.3, -1.4; non-inferior). S. pneumoniae GMT fold-difference (7 serotypes) ranged from 0.9 to 1.1; non-inferior. No statistically significant differences in the incidence of individual AEs were seen when HAV was administered concomitantly vs. non-concomitantly. Three (all Group 2 post-administration of MMRV/PCV-7) of 11 serious AEs were considered possibly vaccine-related: dehydration and gastroenteritis (same subject) on Day 52; febrile seizure on Day 9. No deaths were reported. Antibody responses to each vaccine given concomitantly were non-inferior to HAV given non-concomitantly with MMRV and PCV-7. Administration of HAV with PCV-7 and MMRV had an acceptable safety profile in 12- to 23-mo-old children.
| S-EPMC3906267 | biostudies-literature
Project description:BackgroundMetabolic programming of glucose homeostasis in the first 1,000 days of life may impact lifelong metabolic and cardiovascular health. Continuous glucose monitoring (CGM) devices may help measure the impact of dietary intake on glucose rhythms and metabolism in infants during the complementary feeding period.ObjectivesDemonstrate the feasibility of CGM to measure and quantify glucose variability in response to infant feeding and to evaluate associations between macronutrient meal composition and glucose variability.MethodsThe "FreeStyle Libre Pro®" device interstitial glucose meter was applied to the anterior thigh of 10 healthy 6-12-month-old infants. Parents recorded food intake, time of feeding, and used daily dairies to record sleep time and duration. Descriptive statistics were employed for food intake, sleep and key glycemic parameters over three full days. Mixed linear models were used to assess glycemic changes.ResultsMid-day, afternoon, and evening feeds contained >30 g carbohydrate and induced higher 2-h iAUC (3.42, 3.41, and 3.50 mmol/L*h respectively) compared to early and mid-morning feedings with ≤25 g carbohydrates (iAUC 2.72 and 2.81 mmol/L*h, p < 0.05). Early morning and evening milk feedings contained approximately 9 g of fat and induced a longer time to reach maximal glucose value (Tmax; 75 and 68 min, respectively) compared to lower fat feedings (2.9-5.9 g; Tmax range: 34-60 min; p < 0.05). Incremental glucose value at time of food intake (C0) increased significantly from 0.24 ± 0.39 mM in early morning to 1.07 ± 0.57 mM in the evening (p < 0.05). Over the day, 70% of glucose values remained within the normal range (3.5-5.5 mmol/L), 10% were between 5.5-10 mmol/L, and 20% were < 3.5 mmol/L.ConclusionOur data support the feasibility of using CGM to measure glucose in 6-12-month-old infants. The observation of possible diurnal glucose variability and typical glucose values may have implications for future studies investigating metabolic adaptation to nutritional intake in early life.
| S-EPMC10369064 | biostudies-literature
Project description:IntroductionJapanese encephalitis (JE) virus is the leading cause of viral encephalitis across temperate and tropical zones of Asia. The live attenuated SA 14-14-2 JE vaccine (CD-JEV) is one of three vaccines prequalified by the World Health Organization (WHO) to prevent JE. When incorporating a new vaccine into a country's Expanded Program on Immunization (EPI), it is important to show that the new vaccine can be administered concurrently with other routine pediatric vaccines without impairing the immune responses or changing the safety profiles of the co-administered vaccines. This Phase 4 open-label study evaluated the safety and immunogenicity of measles-mumps-rubella (MMR) vaccine co-administered with CD-JEV.MethodsThe study randomized 628 healthy Filipino children aged between 9 and 10 months to receive MMR and CD-JEV concurrently or separately. MMR immunogenicity was measured 56 days after MMR vaccination using a measles plaque reduction neutralization test (PRNT), anti-mumps immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA), and anti-rubella IgG ELISA, respectively. Neutralizing antibody against JE virus was measured 28 days after CD-JEV vaccination using PRNT. Safety was assessed through solicitation of immediate reactions, adverse events (AEs) within 14 days of vaccination, unsolicited AEs occurring within 28 days, and serious adverse events (SAEs) during participation in the study.Results/conclusionsDuring the study, no post-vaccinal encephalitis cases or related SAEs were reported in either group. Concurrent immunization with CD-JEV and MMR vaccines was not associated with any unusual safety signals when compared with sequential immunization. No significant differences between the regimens were seen in seropositivity or serology titer/concentration results for any of the antigens. Co-administration of CD-JEV and MMR was non-inferior to single administration of either vaccine.
| S-EPMC7509462 | biostudies-literature
Project description:Understanding how we see the world is different from how other people see it is a crucial part of social cognition and is known as visual perspective-taking. Although previous studies have demonstrated that 14-month-old infants have the capacity to compute the visual perspectives of others, it remains unknown whether infants under 12 months also have this ability. In this study, we modified a conventional gaze-following experimental setting in which one toy was placed in front of a model and was hidden by a barrier (Blocked Line of Sight Condition), and another toy was placed without a barrier (Clear Line of Sight Condition). We examined the visual perspective-taking abilities of 48 infants aged 7 and 12 months by measuring the infants' gaze shift towards the gaze-cued toy object with and without a barrier. The results demonstrated that 12-month-old infants could correctly follow a model's gaze if the model's line of sight was clear. In contrast, 7-month-old infants showed no evidence of such capacity. Our findings indicate that 12-month-old infants seem to have the capacity to compute the visual perspective of others.
| S-EPMC8849517 | biostudies-literature
Project description:Infants register and react to informational uncertainty in the environment. They also form expectations about the probability of future events as well as update the expectation according to changes in the environment. A novel line of research has started to investigate infants' and toddlers' behavior under uncertainty. By combining these research areas, the present research investigated 12- and 24-month-old infants' searching behaviors under varying degree of informational uncertainty. An object was hidden in one of three possible locations and probabilistic information about the hiding location was manipulated across trials. Infants' time delay in search initiation for a hidden object linearly increased across the level of informational uncertainty. Infants' successful searching also varied according to probabilistic information. The findings suggest that infants modulate their behaviors based on probabilistic information. We discuss the possibility that infants' behavioral reaction to the environmental uncertainty constitutes the basis for the development of subjective uncertainty.
| S-EPMC7118196 | biostudies-literature
Project description:A foundation of human cognition is the flexibility with which we can represent any object as either a unique individual (my dog Fred) or a member of an object category (dog, animal). This conceptual flexibility is supported by language; the way we name an object is instrumental to our construal of that object as an individual or a category member. Evidence from a new recognition memory task reveals that infants are sensitive to this principled link between naming and object representation by age 12 mo. During training, all infants (n = 77) viewed four distinct objects from the same object category, each introduced in conjunction with either the same novel noun (Consistent Name condition), a distinct novel noun for each object (Distinct Names condition), or the same sine-wave tone sequence (Consistent Tone condition). At test, infants saw each training object again, presented in silence along with a new object from the same category. Infants in the Consistent Name condition showed poor recognition memory at test, suggesting that consistently applied names focused them primarily on commonalities among the named objects at the expense of distinctions among them. Infants in the Distinct Names condition recognized three of the four objects, suggesting that applying distinct names enhanced infants' encoding of the distinctions among the objects. Infants in the control Consistent Tone condition recognized only the object they had most recently seen. Thus, even for infants just beginning to speak their first words, the way in which an object is named guides infants' encoding, representation, and memory for that object.
| S-EPMC7474636 | biostudies-literature
Project description:This study demonstrates evidence for a foundational process underlying active vision in older infants during object play. Using head-mounted eye-tracking and motion capture, looks to an object are shown to be tightly linked to and synchronous with a stilled head, regardless of the duration of gaze, for infants 12 to 24 months of age. Despite being a developmental period of rapid and marked changes in motor abilities, the dynamic coordination of head stabilization and sustained gaze to a visual target is developmentally invariant during the examined age range. The findings indicate that looking with an aligned head and eyes is a fundamental property of human vision and highlights the importance of studying looking behavior in freely moving perceivers in everyday contexts, opening new questions about the role of body movement in both typical and atypical development of visual attention.
| S-EPMC8375006 | biostudies-literature
Project description:BackgroundParental behavior and infant sleep patterns can vary widely both within and between cultures and settings. Breastfeeding during the second half-year of infancy has been associated with frequent night waking, which is perceived as sleep problem among the Western societies. An understanding of sleeping patterns among breastfed infants during the second half-year of infancy is important in supporting continued breastfeeding.ObjectivesThe study aimed to investigate the sleeping patterns among breastfed infants during second half-year of infancy.MethodsThis is a cross-sectional study. Three hundred and forty-two mothers of 6-12 months old breastfed infants completed the questionnaires on socio-demographic factors, breastfeeding practices, and infant sleeping patterns, which were assessed by using the Brief Infant Sleep Questionnaire (BISQ). The Cox regression model was used to assess the factors that were associated with night sleep duration whereas demographic factors and breastfeeding practices that were associated with night waking frequency were investigated using the Poisson regression model.ResultsOn average, the breastfed infants slept for 11 h during the night and most infants were reported to have night waking (96.8%) and were breastfed at least once at night (93.5%). In the adjusted analyses, infants in the age group 9-12 months were less likely to sleep longer compared to infants in the 6-8 months age group [HR 1.52 95% CI (1.17, 1.98)]. A one-hour increase in daytime sleep and in night wakefulness increased the likelihood of waking up at night by 19% and 24%, respectively. Infants who had been vaccinated within the last 7 days and infants who were breastfed to sleep were more likely to have a shorter nighttime sleep duration. Nighttime breastfeeding frequency was significantly associated with a 17% increase in the likelihood of night waking [IRR 1.17 95% CI (1.13, 1.22)]. Infants who slept on their parents' bed were 1.28 times more likely to wake up at night compared to infants who slept in a separate room [IRR 1.28 95% CI (1.05, 1.59)]. Infants of parents who reported that their infants' sleep was not a problem were 34% less likely to wake up compared to infants of parents who reported that their infants' sleep was a problem [IRR 0.66 95% CI (0.49, 0.87)]. CONCLUSIONS FOR PRACTICE: Frequent night waking, bed sharing and night breastfeeding were common among 6-12 months old breastfed infants. Frequent night breastfeeding may lengthen an infant's nighttime sleep duration. The study findings indicate that adequate information and support should be given to breastfeeding mothers in relation to the sleeping pattern of breastfed infants in order to promote continued breastfeeding practices.
| S-EPMC10914878 | biostudies-literature
Project description:Co-administration of vaccines could be an efficient strategy to increase vaccination uptake and reduce the number of clinic visits. This randomized controlled study aimed to evaluate the immunogenicity and safety of enterovirus 71 (EV71) vaccine co-administered with measles-mumps-rubella (MMR) vaccine and live-attenuated Japanese encephalitis vaccine (LA-JEV). A total of 372 healthy infants were randomly assigned in a 1:1:1 ratio to receive simultaneous administration of EV71 vaccine (dose 1) and MMR on d 0 and EV71 vaccine (dose 2) and LA-JEV on d 30 (Group 1); administration of MMR and LA-JEV on d 0 and 30, respectively (Group 2); or administration of doses 1 and 2 of EV71 vaccine on d 0 and 30, respectively (Group 3). The non-inferiority analysis of the seroconversion for EV71 neutralizing antibody after vaccination was the primary outcome. According to per protocol set, antibody response against EV71, measles, mumps, rubella, and Japanese encephalitis (JE) virus was similar regardless of administration schedule. After vaccination, the seroconversion rate of EV71 neutralizing antibody in Group 1 (107 [97.27%] of 110) was non-inferior to that in Group 3 (109 [97.32%] of 112; difference - 0.05% [95% CI - 5.38 to 5.21]). The incidences of adverse reactions were 62.60% (77/123) in Group 1, 54.84% (68/124) in Group 2, and 37.70% (46/122) in Group 3, and most of them were mild to moderate in severity. No vaccine-related serious adverse events were reported. In total, the co-administration of combined EV71 vaccine with MMR and LA-JEV showed no interference with antibody response and demonstrated good safety profiles.
| S-EPMC8903949 | biostudies-literature