A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging.

Background: Using text messaging for vaccine safety monitoring, particularly for non-medically attended events, would be valuable for pandemic influenza and emergency vaccination program preparedness. We assessed the feasibility and acceptability of text messaging to evaluate fever and wheezing post-influenza vaccination in a prospective, observational, multi-site pediatric study.

Methods: Children aged 2-11 years old, with an emphasis on children with asthma, were recruited during the 2014-2015 influenza season from three community-based clinics in New York City, and during the 2014-2015 and 2015-2016 seasons from a private practice in Fall River, Massachusetts.

Direct and indirect effects of PCV13 on nasopharyngeal carriage of PCV13 unique pneumococcal serotypes in Massachusetts' children.

Background: The direct impact of 13-valent pneumococcal conjugate vaccine (PCV13) on colonization with unique PCV13 serotypes and the uptake of vaccine necessary to create indirect protection in nonimmunized children were assessed.

Methods: Carriage surveillance among children <60 months began in July 2010 at a pediatric practice in Boston, MA. Children had nasopharyngeal cultures and parents completed questionnaires detailing demographics and health status.

Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination.

Background: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013.

Methods: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention's Clinical Immunization Safety Assessment network for additional review.

Causality assessment of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS).

Unlabelled: Adverse events following immunization (AEFI) reported to the national Vaccine Adverse Event Reporting System (VAERS) represent true causally related events, as well as events that are temporally, but not necessarily causally related to vaccine.

Objective: We sought to determine if the causal relationships between the vaccine and the AEFI reported to VAERS could be assessed through expert review.

Design: A stratified random sample of 100 VAERS reports received in 2004 contained 13 fatal cases, 19 cases with non-fatal disabilities, 39 other serious non-fatal cases and 29 non-serious cases.

Biologically plausible and evidence-based risk intervals in immunization safety research.

In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety.

Prevalence and genetic diversity of nontypeable haemophilus influenzae in the respiratory tract of infants and primary caregivers.

Background: Nontypeable Haemophilus influenzae (NTHi) causes otitis media, sinusitis, and likely lower respiratory tract infections in children. Colonization, strain diversity, transmission, and antimicrobial susceptibility have implications for both children and their caregivers.

Methods: For 13 months, we conducted a cross-sectional study of NTHi colonization.

Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination.

Background: Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-2010 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) network sought to characterize these SAEs and to assess their possible causal relationship to vaccination.

Overview of the Clinical Consult Case Review of adverse events following immunization: Clinical Immunization Safety Assessment (CISA) network 2004-2009.

Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI).

Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review.

Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants.

Background: Meningococcal disease incidence is highest in children younger than 2 years of age, yet there is no US-licensed vaccine for this age group. A phase III study evaluated the immunogenicity and safety of an investigational Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY).

Materials And Methods: A total of 4180 infants were randomly assigned to receive the HibMenCY at the ages of 2, 4, 6, and 12 to 15 months or the licensed Hib tetanus toxoid conjugate vaccine (ActHIB) at 2, 4, and 6 months and Hib conjugated to N meningitidis outer membrane protein (PedvaxHIB) at 12 to 15 months.

Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States.

An investigational combined Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY-TT) has been developed to protect infants from invasive disease caused by Hib and these meningococcal serogroups without adding injections to the immunization schedule. Incorporation of this novel vaccine into the US vaccination schedule will require demonstration of a lack of immunologic interference with other routine pediatric vaccines. This study assessed the immune response to 7-valent pneumococcal conjugate vaccine (PCV7) and combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine (DTaP-HepB-IPV) when separately co-administered with HibMenCY-TT as compared to a US-licensed H.

Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age.

A total of 236 infants received a fourth Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) dose at 12 to 15 months. One month later, the proportion with anti-PRP antibody > or =1.0 microg/mL and bactericidal titers > or =1:8 to MenC and MenY was 98.

Randomized trial to assess immunogenicity and safety of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in infants.

Background: Study assessed the immunogenicity and safety of an investigational Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) in infants.

Methods: In a single-blinded, controlled study, 609 infants were randomized 1:1 to receive primary vaccination (2, 4, and 6 months) with either HibMenCY-TT or monovalent Haemophilus influenzae type b tetanus toxoid conjugate vaccine (Hib-TT), co-administered with combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine and 7-valent pneumococcal conjugate vaccine. A second control group of 3- to 5-year-old children received a single dose of licensed meningococcal ACWY polysaccharide vaccine (MPSV4).

Immunogenicity and safety of an inactivated hepatitis a vaccine administered concomitantly with a pneumococcal conjugate vaccine in healthy children 15 months of age.

The immunogenicity and safety of hepatitis A vaccine and pneumococcal conjugate vaccine, administered separately or concomitantly in children 15 months of age, were evaluated. After completed vaccinations, antihepatitis A and antipneumococcal geometric mean concentrations were similar across groups. Both vaccines were well-tolerated when given concomitantly during the second year of life.

Universal hepatitis A vaccination in the United States: a call for action.

Previous hepatitis A recommendations for the United States targeted vaccination of at-risk individuals and children living in states and communities with consistently elevated rates of hepatitis A. Recommendations now call for routine hepatitis A vaccination of all children in the United States beginning at age 1 year (12-23 months). Currently, vaccination coverage rates for hepatitis A remain below rates of other routine childhood vaccines.

Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women.

Objective: Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.

Methods: We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age).

Safety and immunogenicity of a combination measles, mumps, rubella and varicella vaccine (ProQuad).

Background: A combination measles, mumps, rubella, and varicella vaccine (ProQuad, Merck & Co., Inc, West Point, PA) was evaluated in five clinical trials. Use of ProQuad would result in fewer injections for children and would facilitate universal immunization against all four diseases.

The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody.

Background: This clinical trial was conducted to demonstrate that each of 3 consistency lots of a combined measles, mumps, rubella and varicella vaccine (MMRV) would be well tolerated, induce clinically acceptable and similar immune responses to each antigen and induce immune responses similar to measles, mumps and rubella vaccine (MMR) administered concomitantly with varicella vaccine (V). An additional objective was to evaluate the persistence of antibodies 1 year postvaccination.

Methods: Study participants 12 to 23 months of age received a single injection of either one of 3 consistency lots of MMRV or MMR + V administered at separate injection sites.

Effectiveness of Centers for Disease Control and Prevention recommendations for outcomes of acute otitis media.

Objectives: To determine whether we could increase adherence to the Centers for Disease Control and Prevention (CDC) recommendations with well-accepted approaches to improving quality of care and adherence to the CDC recommendations resulted in improved outcomes for acute otitis media (AOM).

Methods: A cluster randomization study was conducted in 12 pediatric practices (6 intervention and 6 control sites). The main outcome measures were adherence to the CDC recommendations (modified to include 2 additional antimicrobial agents) and a subsequent antibiotic prescription for AOM within 30 days after diagnosis.

Seven valent pneumococcal conjugate vaccine immunization in two Boston communities: changes in serotypes and antimicrobial susceptibility among Streptococcus pneumoniae isolates.

Background: Seven valent pneumococcal conjugate vaccine (PCV7) was licensed and introduced in 2000 for universal administration of children younger than 2 years of age and for selective immunization of children 2-5 years of age.

Specific Aims: To identify changes in colonization and antimicrobial susceptibility among Streptococcus pneumoniae organisms after introduction of PCV7.

Methods: Infants and children ages 2-24 months were enrolled in surveillance study of nasopharyngeal carriage of S.