Safety, efficacy, and impact on gut microbial ecology of a subspecies LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines.

Introduction: subspecies infantis () may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of LMG11588 supplementation.

Methods: This randomized, placebo-controlled, double-blind study conducted in the Philippines included healthy breastfed and/or formula-fed infants (14-21 days old) randomized for 8 weeks to a control group (CG;  = 77), or any of two experimental groups (EGs): low (Lo-EG; 1*10 CFU/day;  = 75) or high dose (Hi-EG; 1.

Safety of primary immunization with a DTwP-HBV/Hib vaccine in healthy infants: a prospective, open-label, interventional, phase IV clinical study.

Objective: This study aimed to assess the safety of a fully liquid DTwP-HBV/Hib pentavalent vaccine (Eupenta) based on the occurrence of adverse events (AEs) following vaccination.

Methods: This was a prospective, open-label, single-arm, interventional phase IV study. A single intramuscular injection of the study vaccine was administered to infants at approximately 6, 10, and 14 weeks of age, and an end-of-study follow-up visit was scheduled at 18 weeks.

Estimating the annual dengue force of infection from the age of reporting primary infections across urban centres in endemic countries.

Background: Stratifying dengue risk within endemic countries is crucial for allocating limited control interventions. Current methods of monitoring dengue transmission intensity rely on potentially inaccurate incidence estimates. We investigated whether incidence or alternate metrics obtained from standard, or laboratory, surveillance operations represent accurate surrogate indicators of the burden of dengue and can be used to monitor the force of infection (FOI) across urban centres.

Serological Evidence of Widespread Zika Transmission across the Philippines.

Zika virus (ZIKV) exposure across flavivirus-endemic countries, including the Philippines, remains largely unknown despite sporadic case reporting and environmental suitability for transmission. Using laboratory surveillance data from 2016, 997 serum samples were randomly selected from suspected dengue (DENV) case reports across the Philippines and assayed for serological markers of short-term (IgM) and long-term (IgG) ZIKV exposure. Using mixture models, we re-evaluated ZIKV IgM/G seroprevalence thresholds and used catalytic models to quantify the force of infection (attack rate, AR) from age-accumulated ZIKV exposure.

A Narrative Review of Pneumococcal Disease in Children in the Philippines.

This narrative review describes the epidemiology of invasive pneumococcal diseases, nasopharyngeal carriage, and antibiotic resistance of Streptococcus pneumoniae serotypes, and vaccination coverage in children in the Philippines. Epidemiological data show that, despite the availability of the free-of-cost 13-valent pneumococcal conjugate vaccine for infants as part of the National Immunization Program, the burden of pneumococcal disease in young children remains high in the Philippines. The significant variability in data reported between studies highlights an urgent need for active and comprehensive disease surveillance for more accurate estimates of pneumococcal disease in the country.

A serological framework to investigate acute primary and post-primary dengue cases reporting across the Philippines.

Background: In dengue-endemic countries, targeting limited control interventions to populations at risk of severe disease could enable increased efficiency. Individuals who have had their first (primary) dengue infection are at risk of developing more severe secondary disease, thus could be targeted for disease prevention. Currently, there is no reliable algorithm for determining primary and post-primary (infection with more than one flavivirus) status from a single serum sample.

Safety and immunogenicity of the killed bivalent (O1 and O139) whole-cell cholera vaccine in the Philippines.

The killed bivalent (O1 and O139) whole cell oral cholera vaccine (OCV) (Shanchol™) was first licensed in India in 2009 and World Health Organization pre-qualified in 2011. We assessed the safety and immunogenicity of this OCV in the Philippines. This was a phase IV, single-arm, descriptive, open-label study.

Symptomatic Dengue in Children in 10 Asian and Latin American Countries.

Background: The control groups in two phase 3 trials of dengue vaccine efficacy included two large regional cohorts that were followed up for dengue infection. These cohorts provided a sample for epidemiologic analyses of symptomatic dengue in children across 10 countries in Southeast Asia and Latin America in which dengue is endemic.

Methods: We monitored acute febrile illness and virologically confirmed dengue (VCD) in 3424 healthy children, 2 to 16 years of age, in Asia (Indonesia, Malaysia, the Philippines, Thailand, and Vietnam) from June 2011 through December 2013 and in 6939 children, 9 to 18 years of age, in Latin America (Brazil, Colombia, Honduras, Mexico, and Puerto Rico) from June 2011 through April 2014.

Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study.

Objective: To evaluate non-inferiority of three doses of Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus Quinvaxem in a single-dose vial administered with conventional syringe in terms of seroconversion/seroprotection rates for all antibodies (anti-hepatitis B (HB), anti-Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP), anti-diphtheria, anti-tetanus, anti-Bordetella pertussis) at 1 month after primary vaccination.

Methods: Four hundred healthy infants aged 42-65 days were randomized (1:1) to receive Quinvaxem in cPAD or single-dose vial at 6, 10, and 12 weeks of age. Blood samples were collected before vaccination and at 1 month after the third dose to determine seroconversion/seroprotection rates.

Laboratory-confirmed Dengue in Children in Three Regional Hospitals in the Philippines in 2009-2010.

Background: The burden of dengue is high in the Philippines but the prevalence of confirmed cases is unknown, and the disease is subject to underreporting because surveillance of suspected cases is passive. We conducted a prospective epidemiological study to estimate the proportion of laboratory-confirmed dengue among clinically suspected hospitalized cases in the pediatric wards of 3 regional hospitals in the Philippines and to describe the clinical and laboratory features, age distributions, case fatality rates and serotype distributions of these hospitalized cases.

Methods: Patients ≤18 years and hospitalized for suspected dengue were included if they had an axillary temperature ≥38°C for 2-7 days and 2 or more dengue-associated symptoms.

Factors influencing healthcare utilization among children with pneumonia in Muntinlupa City, the Philippines.

We evaluated the factors influencing healthcare utilization among children aged < 5 years with pneumonia symptoms in Muntinlupa City, the Philippines. We interviewed 1,330 caregivers from 190 households per district in seven districts from March to April, 2009 using a standardized questionnaire to obtain information about demographic characteristics, access to healthcare facilities, and potential barriers to healthcare utilization. The mean age of the children was 32 months; 54.

Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity.

Objectives: Levels of stool fatty acid soaps and beneficial bacteria differ between formula-fed and breast-fed infants; addition of specific formula ingredients may reduce these differences. This study evaluated the effects of a term infant formula containing high sn-2 palmitate term infant formula (sn-2) or an identical formula supplemented with oligofructose (OF) at 2 concentrations (sn-2+3 g/L OF, sn-2+5 g/L OF) on stool composition, stool characteristics, and fecal bifidobacteria.

Methods: Healthy, term formula-fed infants 7 to 14 days old (n = 300) were randomized in a double-blind manner to receive standard formula (control), sn-2, sn-2+3 g/L OF, or sn-2+5 g/L OF for 8 weeks.

Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study.

Combination vaccines against diphtheria, tetanus and pertussis (DTP) represent the core of childhood vaccination programs. Quinvaxem, a fully-liquid, pentavalent combination vaccine containing inactivated hepatitis B (HepB), Haemophilus influenzae type b (Hib) and whole-cell pertussis (wP) antigens, and tetanus and diphtheria toxoids, has been shown to be suitable for boosting children primed in infancy with another DTwP-HepB-Hib vaccine. This single-blind, randomized, controlled study was designed to demonstrate non-inferiority of a primary vaccination course (6-10-14 week schedule) of Tritanrix HB+Hib (first dose) and Quinvaxem (second/third doses) versus three doses of Quinvaxem with respect to the seroprotection/seroconversion rates for all antigens one month after vaccination course completion.

Correlation of cellular immune responses with protection against culture-confirmed influenza virus in young children.

The highly sensitive gamma interferon (IFN-gamma) enzyme-linked immunosorbent spot (ELISPOT) assay permits the investigation of the role of cell-mediated immunity (CMI) in the protection of young children against influenza. Preliminary studies of young children confirmed that the IFN-gamma ELISPOT assay was a more sensitive measure of influenza memory immune responses than serum antibody and that among seronegative children aged 6 to <36 months, an intranasal dose of 10(7) fluorescent focus units (FFU) of a live attenuated influenza virus vaccine (CAIV-T) elicited substantial CMI responses. A commercial inactivated influenza virus vaccine elicited CMI responses only in children with some previous exposure to related influenza viruses as determined by detectable antibody levels prevaccination.

Efficacy and safety of a live attenuated, cold-adapted influenza vaccine, trivalent against culture-confirmed influenza in young children in Asia.

Background: This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia.

Methods: In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally > or =28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo.