Positive mental health and wellbeing in adults with cystic fibrosis: A cross sectional study.

Objective: Screening for depression and anxiety in people with cystic fibrosis (CF) is recommended but this alone can miss the opportunity to assess and promote positive mental health and wellbeing. This cross-sectional study assessed positive mental health and wellbeing, and associations with physical health and health-related quality of life (HRQoL) in adults with CF.

Methods: Adults (n = 147) with CF from 9 CF centres in the Republic of Ireland completed the Warwick Edinburgh Mental Well-being scale, the Hospital Anxiety and Depression Scale and the Cystic Fibrosis Questionnaire-Revised.

Health-Related Quality of Life in Adolescents and Adults With Cystic Fibrosis: Physical and Mental Health Predictors.

Background: People with cystic fibrosis face substantial physical, psychological, and social challenges as they move into adolescence and adulthood, which are likely to impact on their health-related quality of life. This study sought to examine the relative importance of physical and mental health variables associated with health-related quality of life in this group.

Methods: Adults and adolescents ( = 174; ≥14 y old) from across 11 adult or pediatric cystic fibrosis clinics in the Republic of Ireland, completed a background questionnaire that contained self-reported physical health variables, pulmonary function (ie, FEV%) and body mass index.

Online versus paper-based screening for depression and anxiety in adults with cystic fibrosis in Ireland: a cross-sectional exploratory study.

Objective: To compare online and paper-based screening for depression and anxiety in adults with cystic fibrosis (CF).

Design And Setting: Cross-sectional study in CF clinics in Ireland and through the Cystic Fibrosis Ireland online community.

Participants: 160 adult patients aged 18 or above were recruited.

Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix(®)): results of two randomized trials.

Background: Pertussis can cause significant morbidity in elderly patients, who can also transmit this disease to infants and young children. There is little data available on the use of acellular pertussis vaccines in recipients ≥65 years of age.

Methods: Two studies examined the safety and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine (Boostrix(®)) in healthy ≥65 year olds.

An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix™) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children.

Background: In the US, it is recommended that 4-6 year old children receive diphtheria-tetanus-acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR), varicella (V), and influenza vaccines. Data relating to the concomitant administration of combination DTaP-IPV vaccine (Kinrix™; GlaxoSmithKline Biologicals) and influenza or V vaccines are currently limited. This study was undertaken to evaluate the immunogenicity and reactogenicity of Kinrix™ when co-administered with MMR (M-M-RII(®), Merck & Co.

Persistence of antibodies 3 years after booster vaccination of adults with combined acellular pertussis, diphtheria and tetanus toxoids vaccine.

The duration of protection after vaccination with reduced antigen content diphtheria, tetanus and acellular pertussis vaccines (Tdap) is not known. Long-term post-vaccination serological data will help to improve understanding of the duration of humoral immunity and guide vaccination policy for the timing of repeat dose administration. The persistence of antibodies to Tdap antigens was measured 3 years after vaccination of adults 19-64 years of age with one of 2 Tdap vaccines (Boostrix(®), GlaxoSmithKline Biologicals; Tdap-B: or Adacel(®), Sanofi Pasteur; Tdap-A).

Immunogenicity and reactogenicity of co-administered tetanus-diphtheria-acellular pertussis (Tdap) and tetravalent meningococcal conjugate (MCV4) vaccines compared to their separate administration.

In the United States, co-administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and tetravalent meningococcal conjugate vaccine (MCV4) is recommended in adolescents. In this clinical study, 1341 adolescents received Tdap (Boostrix® GlaxoSmithKline) and MCV4 (Menactra®, Sanofi-Pasteur) simultaneously or sequentially one month apart. Co-administration of Tdap+MCV4 was well tolerated and immunogenic, resulting in high levels of antibodies against diphtheria, tetanus, pertussis and meningococcal serogroup A,C,W-135 and Y antigens.

Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization.

Background: Prelicensure clinical studies may not include sufficient numbers of subjects to assess the potential for rare postvaccination adverse events. The aim of this postlicensure study (NCT00297856) was to evaluate uncommon outcomes following vaccination with a tetanus, reduced-antigen-content diphtheria, and acellular pertussis vaccine (Tdap, Boostrix GlaxoSmithKline) in a large adolescent cohort.

Methods: We monitored safety outcomes among 13,427 10 to 18-year-old adolescents enrolled in the Northern California Kaiser Permanente Health Care Plan who received Tdap vaccination as part of their normal health care.

Safety and immunogenicity of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine when co-administered with influenza vaccine in adults.

Annual vaccination with trivalent influenza vaccine (TIV), and a single dose of tetanus toxoid-reduced diphtheria toxoid-acellular pertussis (Tdap) vaccine, are both recommended for adults in the US. This study was conducted to obtain information on the safety and immunogenicity of co-administered TIV and a Tdap vaccine (Boostrix) in US adults. The immunogenicity and safety of Tdap and TIV was evaluated in 1,497 adult subjects 19-64 years of age, who were randomized to receive Tdap and TIV either concomitantly or one month apart (TIV followed by Tdap).

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).

Immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid and three-component acellular pertussis vaccine in adults 19-64 years of age.

Purpose: This study was conducted to assess the immunogenicity and safety of a tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine containing three pertussis antigens (Boostrix, Tdap3v), currently licensed in the US for use in adolescents 10-18 years of age, in adults 19-64 years of age.

Methods: 2284 healthy adults, aged 19-64 years, were randomized to receive a single dose of Tdap vaccine, either Tdap3v or a five-pertussis component Tdap vaccine (Adacel, Tdap5v) licensed for adult use in the US. Blood samples were taken before and 1 month after vaccination.

Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age.

Background: In the United States, diphtheria-tetanus-acellular pertussis (DTaP) and inactivated poliovirus (IPV) booster vaccinations are recommended for children 4-6 years of age. A combined DTaP-IPV vaccine is being developed, which would reduce by one the number of injections in this age group.

Methods: Children 4-6 years of age were randomized (1:1:1:1) to receive booster vaccination with 1 of 3 combined DTaP-IPV lots plus the measles, mumps, and rubella vaccine (N = 3156 for pooled lots) or separate doses of DTaP + IPV + measles, mumps, and rubella vaccine (N = 1053).

Immunogenicity of reduced antigen content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine.

Three hundred and nineteen adolescents aged 10-12 years who had been previously vaccinated with five doses of acellular pertussis-containing vaccines received single doses of Tdap (reduced-antigen-content tetanus, diphtheria, acellular pertussis) and hepatitis A vaccines in a double-blind crossover trial. Long-term antibody persistence following vaccination with Tdap at pre-school age was similar to that following vaccination with DTaP (diphtheria-tetanus-acellular pertussis). After the sixth dose booster, Tdap induced a vigorous immune response, consistent with protection against diphtheria, tetanus and pertussis diseases.

Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-containing vaccine.

Objective: The safety of a booster dose of a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis-containing vaccine.

Study Design: Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria-tetanus-acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis-containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular pertussis-containing vaccine dose) versus rates in these same individuals after vaccination with their fifth DTaP dose were assessed.

Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years.

Combination vaccines represent one solution to the problem of increased numbers of injections during single clinic visits. A combined DTaP-IPV (Infanrix-IPV) vaccine has been developed for use as a pre-school booster. Four hundred healthy children aged 4-6 years previously primed with 4 doses of DTaP vaccine (Infanrix), 3 doses of poliovirus vaccine and 1 dose of MMR vaccine were randomized to receive single doses of either the combined DTaP-IPV vaccine or separate DTaP and IPV vaccines in a Phase II trial (DTaP-IPV-047).

Serum antibody responses after intradermal vaccination against influenza.

Background: If found to be safe and immunogenic, reduced doses of influenza vaccine given by the intradermal route could increase the number of available doses of vaccine.

Methods: In an open-label study, we randomly assigned 119 subjects to receive an intradermal injection of trivalent inactivated influenza vaccine, containing 6 mug of hemagglutinin for each antigen (40 percent of the usual dose), and 119 to receive an intramuscular injection of the standard dose of 15 mug of hemagglutinin for each antigen. The two groups were subdivided according to age (18 to 60 years and older than 60 years).

Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b combination vaccination.

Objectives: To assess the impact of a birth dose of hepatitis B vaccine (HepB) on the reactogenicity and immunogenicity of a novel diphtheria-tetanus-acellular pertussis (DTaP)- HepB-inactivated poliovirus (IPV)/ type b (Hib) combination vaccine administered subsequently at 2, 4 and 6 months of age.

Methods: Neonates ( = 550) were randomized into two groups with regard to receipt of HepB at birth. All subjects in both groups received DTaP-HepB-IPV/Hib at 2, 4 and 6 months of age.

Safety and immunogenicity of a combination diphtheria-tetanus toxoids-acellular pertussis-hepatitis B vaccine administered at two, four and six months of age compared with monovalent hepatitis B vaccine administered at birth, one month and six months of age.

Objective: To evaluate the safety and immunogenicity of diphtheria-tetanus toxoids-acellular pertussis (DTPa)-hepatitis B (HepB) combination vaccine given at 2, 4 and 6 months of age compared with monovalent HepB vaccine given at birth, 1 month and 6 months of age and DTPa vaccine given at 2, 4 and 6 months of age.

Methods: Healthy infants were randomized to receive a combination DTPa-HepB vaccine (diphtheria and tetanus toxoids, acellular pertussis antigens and hepatitis B surface antigen), concomitantly with type b and oral poliovirus vaccines at 2, 4 and 6 months of age (Group 1) or HepB vaccine given at birth, 1 month and 6 months of age and DTPa, type b and oral poliovirus vaccines given at 2, 4 and 6 months of age (Group 2). Antibody responses were evaluated at birth, 2 months and 7 months of age.

Interchangeability of 2 diphtheria-tetanus-acellular pertussis vaccines in infancy.

Objective: Currently, 4 diphtheria-tetanus-acellular pertussis (DTaP) vaccines are licensed for pediatric use in the United States, and 2 are commercially available. Although a single manufacturer's DTaP vaccine should be used for all 3 doses of the primary immunization series, some circumstances result in infants receiving DTaP vaccines from more than 1 manufacturer. The purpose of this study was to evaluate the safety and immunogenicity of a mixed sequence of 2 different DTaP vaccines.