View clinical trials related to Healthy Infants.
Filter by:This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits. Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age. Safety, growth and tolerance parameters will be followed and collected throughout the study.
The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.
The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesia™" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults > 18 years old).
Background: There is no reliable method for vitamin A (VA) assessment for infants and young children. Serum VA concentration is not an authenticate indicator of VA status, while existing deuterium- VA isotope dilution methods to determine the whole body VA status require 3 weeks and not applicable for infants and children. The investigator's research group recently developed a new simplified equation to measure VA pool size in 4-5 days, correlated with compartmental model-predicted value and estimate VA pool size in adults with high precision. In this study, we validate the method in healthy infants and infants with an inflammatory condition. Hypothesis: Whole-body VA status in infant and children can be estimated without accounting for the fractional catabolic rate in the context of an inflammatory condition Specific Objectives: In this study, the investigators propose to determine the early time point equation for assessing VA pool size in infants with or without inflammatory condition using model-based compartmental analysis from the fraction of oral dose-derived 13C10-VA and 13C4-VA in plasma over time. Methods: A total of 183 infants (9-18 mo of age) will participate in this study in the following two phases of the "Super Kid study" that ensure no more than 2 venous blood samples from each infant, even though multiple time points (at least 4 subjects / time-point) over a 28-day study period will be available for mathematical modeling. In this study, investigators will use two different stable isotopic vitamin A e.g., 13C10-retinyl acetate and 13C4-retinyl acetate. 400 μg of these isotopes, dissolved in 0.5 mL of sunflower oil, will be provided directly into the infant's mouth by using a direct replacement pipette. Mothers will be asked to breastfeed their infant after oral dosing to enhance absorption of the labeled vitamin A. Specific activity of 13C10- and 13C4- retinyl acetate in the blood samples will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS). Dietary and morbidity questionnaires will be used. Investigators will also use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). This vaccination is beneficial to the infants since the World Health Organization recommends a booster vaccination dose. At the end of the study, PENTA vaccines will also be provided to the study infants in the "no-vaccine" group. (A) 115 infants will be enrolled randomly into 16 groups of them 40 infants will be in the first group, while other infants will be assigned in the other 15 groups (n=5/group). On day 0 (at 0h), all infants (n=115) will receive an oral dose of 13C10-retinyl acetate. Blood samples (5 mL) will be taken from 6h to 16th day of dosing at 9 different time-points. On day 16 (at 0h), randomly selected 50% infants (n=20) in the first group, as well as 30 infants in the other 6 groups, will receive PENTA vaccines, while the other 50% infants (n=20) in the first Group, as well as 45 infants in the other 9 groups, will receive no vaccines. 24 hours after vaccination (On day 17) a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP (QuikRead go, Orion, Finland). Infants who do not develop inflammation (CRP> 5mg/L) after PENTA vaccination will be excluded from the study. On day 17 (at 0h), all infants (n=115) will receive another oral dose of 13C4-retinyl acetate. Blood samples (5mL) will be collected from day 16 to day 28 at 11 different time-points for each of the vaccinated and non-vaccinated infants. This study will also assess the absorption of isotopic retinol by determining in total excreted stool up to 72 h post isotope dosing in a subsample of infants (B) 68 infants will be enrolled in this phase. Of them, 28 infants will be assigned randomly into 7 groups (n=4/group). They will receive PENTA vaccines on day -1, and the next day (day 0) they will receive an oral dose of 13C4-retinyl acetate. Blood samples (5mL) will be collected from day 1 to day 28 at 8 different time points. In a separate design, 40 infants will receive an oral dose of 13C10-retinyl acetate on day 0 and blood samples (5mL) will be collected on day 4. On day 7 they all will receive another oral dose of 13C4-retinyl acetate (400 μg, dissolved in 0.5 mL of sunflower oil). On day 10, infants will receive PENTA vaccines (n=30) or no vaccine (n=10) and 1-day after vaccination, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group (day 11). Outcome measures: The early time point equation for assessing VA pool size in a group of infants with or without inflammation
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.
Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide and is estimated to account for 600,000 deaths in children <5 years of age. However, live oral enteric vaccines (e.g. OPV, cholera vaccines, typhoid vaccine) have been less immunogenic in poor communities with high levels of malnutrition and poor sanitation. Rotavirus vaccines also appear to be less immunogenic in the setting where they are most needed. High maternal antibody (IgG) to rotavirus and breast feeding near the time of vaccination may inhibit rotavirus vaccine effectiveness. We propose a quick study to look at practical ways to improve the immunogenicity of rotavirus vaccine in our own setting in Bangladesh. The objectives are to assess if delaying Rotarix vaccination will improve the immune response to the vaccine and to assess if avoiding breastfeeding in the 45 minutes before and after vaccine administration will improve the immune response to administration of Rotarix vaccine. The study will be conducted in the urban Dhaka Mirpur Community, a setting where previous rotavirus vaccine immunogenicity studies have been successfully conducted. A total of 300 infant will be randomly assigned to one of the following groups: 1) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine. 2) Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration. 3) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine. 4) Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration. Blood and stool samples will be collected from infants and breast milk from mothers. The primary outcome is to determine the sero-conversion rate of anti-rotavirus IgA in different groups of infants.
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.
This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.
The proposed Japanese Encephalitis (JE)Vaccine study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of JE live attenuated SA 14-14-2 vaccine manufactured in a new GMP facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study will enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, JEV05 will provide local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This will be the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
This randomized clinical trial will assess the immune response in infants following administration of three types of oral poliovirus vaccine trivalent OPV (tOPV), monovalent OPV type 1 (mOPV1), bivalent OPV types 1 and 3 (bOPV) using two different schedules: a short schedule with administration at two week intervals and the usual schedule at four week intervals. The results of this study will guide the Global Polio Eradication Program in the implementation of new strategies that may: 1) improve the quality of the response to outbreaks following importation of wild poliovirus type 1 by shortening the interval at which several OPV doses are provided; 2) prevent alternate outbreaks of type 1 and type 3 poliovirus by using bOPV in outbreak responses in countries with weak routine immunization systems; and 3) prevent the emergence of type 2 vaccine-derived poliovirus through the replacement of tOPV with bOPV in immunization campaigns and routine immunization programs.