Paralytic syndromes in children: epidemiology and relationship to vaccination.

Acute flaccid paralysis is a standard outcome for detection of poliomyelitis globally and an ongoing potential vaccine-associated adverse event concern for polio, influenza, and meningococcal vaccines. No systematic population-based data on the epidemiologic and clinical features of this condition, or its potential association with immunization, have been reported from the United States. The present retrospective cohort study of acute flaccid paralysis in the Southern and Northern California Kaiser Permanente Health Care Plans was conducted using computerized diagnosis data and medical record review of potential cases among children aged 1 month to <15 years and diagnosed from January 1, 1992 through December 31, 1998.

A population-based, postlicensure evaluation of the safety of a combination diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccine in a large managed care organization.

Background: Prelicensure studies of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus vaccine suggested that there were higher rates of fever after its administration than when its component antigens were given separately.

Methods: We conducted an open, controlled, cohort study to evaluate selected potential adverse events after receipt of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine in the Southern California Kaiser Permanente Health Care Plan. From April 2003 through June 2005, we identified 61,004 infants who received >or=1 dose of vaccine (120000 total doses).

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.

Bordetella Pertussis infections in vaccinated and unvaccinated adolescents and adults, as assessed in a national prospective randomized Acellular Pertussis Vaccine Trial (APERT).

Background: Acellular pertussis (aP) booster immunizations have been recommended for adolescents and older persons to enhance long-term protection and to possibly reduce community transmission of infections.

Methods: This was a multicenter, randomized, double-blind vaccine trial in which one-half of the subjects received aP vaccine and one-half received hepatitis A vaccine (control subjects). All subjects were observed for almost 2 years for cough illnesses, and all underwent microbiologic and serologic studies for detection of pertussis infection.

Shift in the epidemiology of pertussis infection: an indication for pertussis vaccine boosters for adults?

Pertussis vaccination of young children has been effective in reducing the overall disease burden due to Bordetella pertussis in many countries. However, the disease has not been eliminated, although humans are the only known host of this pathogen. In fact, in some countries, the number of reported cases has increased dramatically from their nadir and epidemics routinely occur.

Efficacy of an acellular pertussis vaccine among adolescents and adults.

Background: Pertussis immunization of adults may be necessary to improve the control of a rising burden of disease and infection. This trial of an acellular pertussis vaccine among adolescents and adults evaluated the incidence of pertussis, vaccine safety, immunogenicity, and protective efficacy.

Methods: Bordetella pertussis infections and illnesses were prospectively assessed in 2781 healthy subjects between the ages of 15 and 65 years who were enrolled in a national multicenter, randomized, double-blind trial of an acellular pertussis vaccine.

PEDIARIX: clinical trials.

PEDIARIX is the first pentavalent combination vaccine licensed for use in infants in the USA. This vaccine is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B and poliovirus. This article reviews the available data regarding the vaccine's immunogenicity and safety.

Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety datalink project.

Background: There have been no population-based studies of the potential association between neonatal death and newborn immunization with hepatitis B vaccine (HBV).

Methods: As part of the Vaccine Safety Datalink Project, we defined a birth cohort at Southern and Northern California Kaiser Permanente Health Plans of more than 350,000 live births from 1993 to 1998 and ascertained all deaths occurring under 29 days of age. We compared the proportions of deaths among birth HBV-vaccinated and unvaccinated newborns and reviewed the causes and circumstances of their deaths.

Immune responses and antibody decay after immunization of adolescents and adults with an acellular pertussis vaccine: the APERT Study.

As part of a prospective acellular pertussis (ACP) vaccine efficacy trial, 5 serum samples were obtained, over an 18-month period, from 101 ACP-vaccine recipients and 99 control subjects, to assess ACP antibody response and decay. Immunoglobulin (Ig) G and IgA antibodies to pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae 2/3 (FIM) were measured by enzyme-linked immunosorbant assay, and titers of agglutinin were determined. Of the subjects, 16%-19% had preimmunization values of antibodies to PT that were above the assay's limit of quantitation (LOQ); in contrast, 36%-63% of the subjects had preimmunization values of antibodies to FHA, PRN, or FIM that were above the LOQ.

Evaluation of strategies for use of acellular pertussis vaccine in adolescents and adults: a cost-benefit analysis.

Pertussis is increasingly recognized as a source of infection in adults who then commonly infect young children. Immunity to illness caused by Bordetella pertussis is not long-lived, so optimal control of pertussis may require booster immunizations. In a cost-benefit analysis, we evaluated the benefits of 7 independent strategies for administering a pertussis booster, in the form of a diphtheria-tetanus-acellular pertussis vaccine, to adolescents and adults.

Pertussis: persistent pathogen, imperfect vaccines.

Routine use of pertussis vaccines has diminished the incidence of this disease but has not eliminated the pathogen. Pertussis remains a significant cause of disease in both very young infants and in the adolescent and adult populations. Acellular pertussis vaccines have fewer adverse reactions compared with whole-cell pertussis vaccines.

Heptavalent pneumococcal vaccine conjugated to outer membrane protein of Neisseria meningitidis serogroup b and nasopharyngeal carriage of Streptococcus pneumoniae in infants.

Background: Streptococcus pneumoniae (Sp) is an important bacterial pathogen in children. Nasopharyngeal (NP) colonization of S. pneumoniae is necessary for person-to-person transmission and often precedes invasive disease.

Safety and immunogenicity of a heptavalent pneumococcal conjugate vaccine in infants.

Objective: To evaluate the safety and immunogenicity of two lots of a heptavalent Streptococcus pneumoniae conjugate vaccine (PCV) containing seven capsular polysaccharide serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) conjugated to the outer membrane complex of Neisseria meningitidis serogroup B (OMPC) and administered to infants at 2, 4, 6, and 12 months of age.

Methods: One hundred twenty infants were randomly assigned to concurrently receive PCV-OMPC and one of two Haemophilus influenzae type b (Hib) conjugate-DTwP combination vaccines: (1) Hib with a heterologous protein carrier (CRM(197), TETRAMUNE, Group 1) or (2) an experimental Hib-hepatitis b combination vaccine with the homologous carrier (OMPC, Group 2). All infants in Groups 1 and 2 received PCV-OMPC (lot 1) at 12 months of age.

Lack of association between rotavirus infection and intussusception: implications for use of attenuated rotavirus vaccines.

Background: Withdrawal of the tetravalent rhesus-human rotavirus vaccine Rotashield because of its association with intussusception raised concerns about a potential link between natural rotavirus disease and intussusception. Our objective was to determine whether such an association exists.

Methods: In the Southern California Kaiser Permanente Health Care Plan, a large health maintenance organization, from October, 1992, to July, 1999, we retrospectively identified by computerized data and medical charts all children <3 years old with intussusception, and from 1997 to 1999 we independently identified by prospective clinical and laboratory evaluation children <3 years old with rotavirus diarrhea.

Prospective, randomized, placebo-controlled evaluation of the safety and immunogenicity of three lots of intranasal trivalent influenza vaccine among young children.

Background: Trivalent formulations of an experimental, cold-adapted, intranasal influenza (CAIV) vaccine have been shown to be safe, immunogenic and efficacious in young children.

Methods: We evaluated the safety and immunogenicity of three consistency lots of CAIV in children 12 to 36 months of age randomized to one of five groups: Groups 1, 2 and 3 received separate lots containing A/Shenzhen/227/95 (H1N1), A/Wuhan/359/95(H3N2) and B/Harbin/7/94-like viral strains. Group 4 received an earlier efficacy trial lot which included a different H1N1 strain (A/Texas/36/91-like); and Group 5 received placebo.

Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants.

Introduction: The objectives of this study were to evaluate the safety and immunogenicity of a new combination vaccine (DTaP-HB-IPV) containing diphtheria, tetanus, acellular pertussis and hepatitis B (HB) and a new inactivated poliovirus vaccine (IPV) manufactured by GlaxoSmithKline (GSK). This vaccine was given in an all IPV or sequential IPV and oral polio vaccine (OPV) schedule. Another combination vaccine, DTaP-HB (GSK), was similarly evaluated given with OPV or IPV.

Immunogenicity of a Haemophilus influenzae type b-tetanus toxoid conjugate vaccine when mixed with a diphtheria-tetanus-acellular pertussis-hepatitis B combination vaccine.

Background: Combination vaccines are urgently needed to reduce the number of injections given to young children. The aim of the study was to evaluate the safety and immunogenicity of a combination vaccine that contains diphtheria and tetanus toxoids and acellular pertussis antigens (DTaP), recombinant hepatitis B surface antigen (HepB) and Haemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus toxoid (PRP-T).

Methods: Four hundred five infants were randomized equally to three groups and immunized at 2, 4 and 6 months of age with: (1) DTaP/HepB vaccine used to reconstitute lyophilized PRP-T vaccine and administered as a single injection; (2) DTaP/HepB vaccine and PRP-T vaccine administered as two separate injections; or (3) DTaP, HepB and PRP-T vaccines administered as three separate injections.

Epidemiological, clinical, and laboratory aspects of pertussis in adults.

In populations without immunization, pertussis is a high-incidence, endemic disease with cyclic epidemic peaks occurring every 2-5 years. The universal use of pertussis vaccines in children results in a marked reduction in incidence, but the frequency of disease cycles does not lengthen. This indicates that the organism (Bordetella pertussis) remains prevalent in the population.

Pertussis in the preantibiotic and prevaccine era, with emphasis on adult pertussis.

Pertussis was first recognized as an epidemic disease in the 16th century. The classic illness is a three-stage illness (catarrhal, spasmodic, and convalescent), with a distinctive cough, and its characteristics today are similar to those in the prevaccine era. In the prevaccine era, the calculated attack rate was 872/100,000 population, and the majority of cases occurred in children <5 years of age.

Epidemiology of invasive pneumococcal disease in southern California: implications for the design and conduct of a pneumococcal conjugate vaccine efficacy trial.

Population-based prospective surveillance of invasive pneumococcal disease was done in Southern California from 31 March 1992 to 1 April 1995; 814 cases were identified, for an incidence of 12.5/100,000 persons/year. The incidence among persons < or = 2, < or = 5, and > or = 65 years of age was 145, 72, and 32/100,000, respectively.

Comparative safety and immunogenicity of two recombinant hepatitis B vaccines given to infants at two, four and six months of age.

Objectives: To evaluate the relative safety and immunogenicity of the two recombinant hepatitis B vaccines licensed in the United States with doses recommended for routine immunization of low risk infants and a schedule that corresponds with routine pediatric visits.

Methods: Healthy infants were immunized at 2, 4 and 6 months of age with hepatitis B vaccine manufactured by either SmithKline Beecham (Engerix-B, 10 micrograms/dose, n = 228) or Merck and Co. (Recombivax HB, 2.

Safety and immunogenicity of a recombinant hepatitis B vaccine administered to infants at 2, 4 and 6 months of age. The Kaiser-UCLA Vaccine Study Group.

A recombinant hepatitis B vaccine was administered to over 5000 infants in a prospective, randomized and blinded study. Infants were given either recombinant hepatitis B vaccine (Engerix-B, SmithKline Beecham Pharmaceuticals, 10 micrograms dose-1) or a Haemophilus influenzae type b (Hib) conjugate vaccine at 2, 4 and 6 months of age simultaneously with diphtheria-tetanus-pertussis and oral polio vaccines. Adverse reactions were ascertained by parental reports and interviews, and review of medical records.

Safety and immunogenicity of a serogroups A/C Neisseria meningitidis oligosaccharide-protein conjugate vaccine in young children. A randomized controlled trial.

Objective: To assess the safety and immunogenicity of a bivalent serogroups A/C meningococcal oligosaccharide-protein conjugate vaccine compared with the licensed meningococcal polysaccharide vaccine.

Design: Randomized controlled trial.

Study Population: Ninety healthy 18- to 24-month-old children who were seen at a southern California Kaiser Permanente clinic.