The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants. From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1∶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group: 346; control group: 350), and 692 were given the third dose (test group: 344; Control group: 348). The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1∶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (<0.001). ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.
Antibodies, Bacterial ; Humans ; Infant ; Meningococcal Vaccines ; adverse effects ; immunology ; Vaccines, Conjugate

Pneumococcal disease is a serious global public health problem and a leading cause of morbidity and mortality of children and adults in China. Antibiotics are commonly used to treat pneumococcal disease. However, antibiotic resistance to Streptococcus pneumoniae has become a severe problem around the world due to widespread antibiotic use. Immunoprophylaxis of pneumococcal disease with pneumococcal vaccines is therefore of great importance. In this article, we review the etiology, clinical presentation, epidemiology, and disease burden of pneumococcal disease and the vaccinology of pneumococcal vaccines. Our review is based on the Expert Consensus on Immunoprophylaxis of Pneumococcal Disease (2017 version), the Pneumococcal Vaccines WHO Position Paper (2019), and recent national and international scientific advances. This consensus article aims to provide public health and vaccination staff with appropriate evidence for pneumococcal vaccine use and to improve professional capacity for pneumococcal disease prevention and control.
Adult ; Child ; China/epidemiology* ; Consensus ; Humans ; Pneumococcal Infections/prevention & control* ; Pneumococcal Vaccines/therapeutic use* ; Streptococcus pneumoniae/immunology* ; Vaccines, Conjugate/administration & dosage*

Meningococcal meningitis is an acute, severe respiratory infectious disease caused by Neisseria meningitidis. Immunization with meningococcal vaccine is the most effective measure to control and prevent transmission of meningococcal meningitis. Meningococcal vaccines in the Chinese market include meningococcal polysaccharide vaccine, meningococcal polysaccharide conjugate vaccine, and a combined vaccine containing meningococcal polysaccharide conjugate vaccine. This article reviews research progress on the efficacy, safety, and cost-effectiveness of meningococcal vaccines, particularly in the Chinese market, to support appropriate use of the various meningococcal vaccines for preventing meningococcal meningitis.
Cost-Benefit Analysis ; Humans ; Immunization/economics* ; Meningitis, Meningococcal/prevention & control* ; Meningococcal Vaccines/immunology* ; Vaccination/economics* ; Vaccines, Conjugate/immunology*

Pneumococcal disease is one of the serious global public health problems, and an important leading cause of the morbidity and mortality of children and adults in China. Currently, antibiotics are the most choices for its clinical treatment. However, antibiotic resistance of Streptococcus pneumoniae has become a severe problem around the world due to the wide use of antibiotics. Hence, the prevention of pneumococcal disease by using pneumococcal vaccines is of great importance. In this article, we reviewed the etiology, clinic, epidemiology, disease burden of pneumococcal disease, and the vaccinology of pneumococcal vaccines, based on the Pneumococcal Vaccines WHO Position Paper (2012) and other latest evidence globally, to introduce comprehensive knowledge of pneumococcal disease, and for the purpose to improve the capacity of the professionals working on pneumococcal disease control and prevention and to provide appropriate evidences of pneumococcal vaccine applications for people who are engaged in public health and immunization vaccination.
Adult ; Child ; China/epidemiology* ; Consensus ; Humans ; Pneumococcal Infections/prevention & control* ; Pneumococcal Vaccines/administration & dosage* ; Public Health ; Streptococcus pneumoniae/immunology* ; Vaccination ; Vaccines, Conjugate/administration & dosage*

This study was performed to measure early changes in the serotype distribution of pneumococci isolated from children with invasive disease during the 3-year period following the introduction of 10- and 13-valent pneumococcal conjugate vaccines (PCVs) in Korea. From January 2011 to December 2013 at 25 hospitals located throughout Korea, pneumococci were isolated among children who had invasive pneumococcal disease (IPD). Serotypes were determined using the Quellung reaction, and the change in serotype distribution was analyzed. Seventy-five cases of IPD were included. Eighty percent of patients were aged 3-59 months, and 32% had a comorbidity that increased the risk of pneumococcal infection. The most common serotypes were 19A (32.0%), 10A (8.0%), and 15C (6.7%). The PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, and 6A) accounted for 14.7% of the total isolates and the PCV13 minus PCV7 types (1, 3, 5, 7F and 19A) accounted for 32.0% of the total isolates. Serotype 19A was the only serotype in the PCV13 minus PCV7 group. The proportion of serotype 19A showed decreasing tendency from 37.5% in 2011 to 22.2% in 2013 (P = 0.309), while the proportion of non-PCV13 types showed increasing tendency from 45.8% in 2011 to 72.2% in 2013 (P = 0.108). Shortly after the introduction of extended-valent PCVs in Korea, serotype 19A continued to be the most common serotype causing IPD in children. Subsequently, the proportion of 19A decreased, and non-vaccine serotypes emerged as an important cause of IPD. The impact of extended-valent vaccines must be continuously monitored.
Adolescent ; Bacteremia/complications/diagnosis ; Child ; Child, Preschool ; Female ; Hospitals ; Humans ; Infant ; Male ; Pneumococcal Infections/microbiology/*prevention & control ; Pneumococcal Vaccines/*immunology ; Republic of Korea ; Serotyping ; Streptococcus pneumoniae/*classification/isolation & purification ; Vaccines, Conjugate/*immunology

Although it is well known that pneumococcal conjugate vaccines provide cross-protection against some vaccine-related serotypes, these mechanisms are still unclear. This study was performed to investigate the role of cross-protective IgM antibodies against vaccine-related serotypes 6A, 6C, and 19A induced in children aged 12-23 months after immunization with 7-valent pneumococcal conjugate vaccine (PCV7). We obtained serum samples from 18 Korean children aged 12-23 months after a PCV7 booster immunization. The serum IgG and IgM concentrations of serotypes 6B and 19F were measured by enzyme-linked immunosorbent assay (ELISA) in serum. The opsonic indices (OIs) against vaccine serotypes 6B and 19F and vaccine-related serotypes 6A, 6C, and 19A were determined by an opsonophagocytic killing assay (OPA) in IgM-depleted and control serum. Both IgG and IgM antibodies in ELISA and opsonic indices in OPA against serotypes 6B and 19F were demonstrated in the immune serum. IgM depletion decreased the OIs against vaccine serotypes 6B (geometric means of OIs (GMIs) of 3,009 vs. 1,396, 38% reduction) and 19F (1,117 vs. 750, 36% reduction). In addition, IgM depletion markedly decreased the OIs against vaccine-related serotypes 6A (GMIs of 961 vs. 329, 70% reduction), 6C (432 vs. 185, 72% reduction), and 19A (301 vs. 166, 58% reduction). The booster immunization PCV7 induced protective antibodies in the form of both IgG and IgM isotypes. IgM antibodies contributed to eliciting cross-protection against vaccine-related serotypes as well as against vaccine serotypes.
Antibodies, Bacterial/blood ; Antibodies, Neutralizing/blood ; Enzyme-Linked Immunosorbent Assay ; Heptavalent Pneumococcal Conjugate Vaccine/*immunology ; Humans ; Immunoglobulin M/*blood ; Infant ; Pneumococcal Infections/*prevention & control ; Pneumococcal Vaccines/*immunology ; Serogroup ; Streptococcus pneumoniae/immunology

The purpose of this study was to investigate the association between asthma and invasive pneumococcal disease (IPD) in Korea. A retrospective population-based cohort study was conducted using the Korean Health Insurance Review and Assessment database 2010-2011. The subjects included 935,106 (2010) and 952,295 (2011), of whom 398 (2010) and 428 (2011) patients with IPD were identified. There was significant difference in the prevalence of IPD in patients with and without asthma (0.07% vs. 0.02% in 2010 and 0.08% vs. 0.01% in 2011; P<0.001). After adjusting for age and gender, patients with asthma showed over a three-fold increased risk of IPD compared with patients without asthma (adjusted odds ratio [aOR] 3.90, 95% confidence interval [CI] 3.02-5.03 in 2010 / aOR, 5.44; 95% CI, 4.10-7.22 in 2011; P<0.001). These findings were also significant in children (aOR, 2.08; 95% CI, 1.25-3.45 in 2010; P=0.005 / aOR, 3.26; 95% CI, 1.74-6.11 in 2011; P<0.001). Although diabetes mellitus was also significantly associated with IPD, relatively low ORs compared with those of asthma were noted (aOR, 1.85; 95% CI, 1.35-2.54 in 2010 / aOR, 2.40; 95% CI, 1.78-3.24 in 2011; P<0.001). Both children and adults with asthma are at increased risk of developing IPD.
Adolescent ; Adult ; Aged ; Asthma/complications/*epidemiology ; Child ; Cohort Studies ; Diabetes Mellitus/epidemiology ; Heptavalent Pneumococcal Conjugate Vaccine/immunology ; Humans ; Immunologic Deficiency Syndromes/complications/*epidemiology ; Middle Aged ; Pneumococcal Infections/complications/*epidemiology ; Pneumococcal Vaccines/immunology ; Prevalence ; Republic of Korea/epidemiology ; Retrospective Studies ; Streptococcus pneumoniae/pathogenicity ; Young Adult

OBJECTIVETo evaluate the safety of meningococcal group AC bivalent polysaccharide conjugate vaccine among children aged 5-24 months old.

METHODSFrom July 2011 to June 2012, a total of 34 411 children aged 5-24 month-old who voluntarily vaccinated meningococcal group AC bivalent polysaccharide conjugate vaccine in Zhongshan city were included. The adverse effects within 72 hours were recorded and analyzed.

RESULTS34 411 children were recruited, including 18 708 boys (54.36%), whose mean age were ( 11.4 ± 3.9 ) months old.Within 72 hours, the incidence rates of local adverse effects were 0.76% (261/34 411) for erythema,0.57% (197/34 411) for sclerosis,0.56% (191/34 411) for swelling,0.42% (143/34 411) for pain,0.15% (53/34 411) for pruritus, and 0.15% (50/34 411) for rash on the injection site. The overall incidence rate of local adverse effects was 1.61% (554/34 411; 95%CI:1.48%-1.74%). The incidence rates of systemic adverse effects were 0.98% (312/34 411) for fever,0.48% (164/34 411) for anorexia,0.31% (108/34 411) for diarrhea,0.29% (100/34 411) for malaise,0.20% (70/34 411) for nausea and vomiting, and 0.08% (26/34 411) for headache. The overall incidence rate of systemic adverse effects was 1.64% (565/34 411; 95%CI:1.51%-1.78%).25 children (0.07%) had hyperpyrexia ( > 39°C), and the time of duration lasted less than 48 hours.16 children (0.05%) had symptoms of cold, such as cough and catarrh.No accident and other serious events were reported. The incidence rate of systemic adverse effects among boys was 1.79% (334/18 708), which was higher than that of girls (1.47%, 231/15 703), the difference showed statistical significance (χ(2) = 5.22, P < 0.01). The incidence rate of systemic adverse effects among children aged 5-12 month-old was 1.78% (411/23 113), which was higher than that among children aged 13-24 month-old (1.36%, 154/11 298), the difference showed statistical significance (χ(2) = 8.10, P < 0.01). The incidence rate of local adverse effects in children vaccinated the first dose was 1.72% (536/31 129), which was higher than that in children vaccinated the second or third dose (0.55%, 18/3282), the difference showed statistical significance (χ(2) = 25.81, P < 0.01). The incidence rate of systemic adverse effects in children vaccinated the first dose was 1.73% (539/31 129), which was higher than that in children vaccinated the second or third dose (0.79%, 26/5282), whose difference also showed statistical significance (χ(2) = 16.22, P < 0.01).

CONCLUSIONThe safety of meningococcal group AC bivalent polysaccharide conjugate vaccine among children aged 5-24 months old is relative good.

Female ; Humans ; Infant ; Male ; Meningitis, Meningococcal ; microbiology ; prevention & control ; Meningococcal Vaccines ; administration & dosage ; adverse effects ; immunology ; Neisseria meningitidis, Serogroup A ; Neisseria meningitidis, Serogroup C ; Polysaccharides, Bacterial ; immunology ; Vaccines, Conjugate ; administration & dosage ; adverse effects ; immunology

We investigated serotype distribution and antimicrobial resistance of pneumococcal carriage isolates from children after optional immunization with the 7-valent pneumococcal conjugate vaccine (PCV7) in Korea. From June 2009 to June 2010, 205 (16.5%) pneumococcal isolates were obtained from 1,243 nasopharyngeal aspirates of infants and children at Seoul National University Children's Hospital, Korea. Serotype was determined by Quellung reaction and antibiotic susceptibility was tested by E-test. The results were compared to previous studies done in the pre-PCV7 period. In this study, the most common serotypes were 6A (15.3%), 19A (14.7%), 19F (10.2%), 35B (7.3%), and 6D (5.6%). The proportion of PCV7 serotypes decreased from 61.9% to 23.8% (P < 0.001). The overall penicillin nonsusceptibility rate increased from 83.5% to 95.4% (P = 0.001). This study demonstrates the impact of optional PCV7 vaccination in Korea; the proportion of all PCV7 serotypes except 19F decreased while antimicrobial resistant serotypes 6A and 19A further increased.
Anti-Bacterial Agents/pharmacology ; Child, Preschool ; Drug Resistance, Bacterial/drug effects ; Humans ; Infant ; Microbial Sensitivity Tests ; Nasopharynx/*microbiology ; Pneumococcal Infections/immunology/prevention & control ; Republic of Korea ; Serotyping ; Streptococcus pneumoniae/classification/*isolation & purification ; Vaccination ; Vaccines, Conjugate/*immunology

Acute otitis media (AOM) and otitis media with effusion (OME) are common infections in children, and their diagnosis and treatment have significant impacts on the health of children and the costs of providing national medical care. In 2009, the Korean Otologic Society organized a committee composed of experts in the field of otolaryngology, pediatrics, and family medicine to develop Korean clinical practice guidelines (CPG) for otitis media in children with the goal of meeting regional medical and social needs in Korea. For this purpose, the committee adapted existing guidelines. A comprehensive literature review was carried out primarily from 2004 to 2009 using medical search engines including data from Korea. A draft was written after a national questionnaire survey and several public audits, and it was editorially supervised by senior advisors before publication of the final report. These evidence-based guidelines for the management of otitis media in children provide recommendations to primary practitioners for the diagnosis and treatment of children younger than 15 yr old with uncomplicated AOM and OME. The guidelines include recommendations regarding diagnosis, treatment options, prevention and parent education, medical records, referral, and complementary/alternative medicine for treating pediatric otitis media.
Age Factors ; Anti-Bacterial Agents/therapeutic use ; Asian Continental Ancestry Group ; Caregivers/education ; Child ; Drug Therapy, Combination ; Fever ; Hearing Tests ; Humans ; Otitis Media/*diagnosis/drug therapy ; Otitis Media with Effusion/diagnosis/surgery ; Pneumococcal Infections/prevention & control ; Republic of Korea ; Risk Factors ; Vaccines, Conjugate/immunology