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- Abu-Elyazeed, R R, et al.
(författare)
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Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age : results from a randomised, controlled, double-blind trial
- 2013
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X .- 1873-2518. ; 31:51, s. 6136-6143
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed.METHODS: Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus.RESULTS: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants.CONCLUSION: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.
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| 2. |
- Jacquet, J M, et al.
(författare)
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Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age : a review
- 2006
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Ingår i: Vaccine. - : Elsevier BV. - 0264-410X .- 1873-2518. ; 24:13, s. 2440-2448
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Tidskriftsartikel (refereegranskat)abstract
- A combined DTPa-IPV booster vaccine was administered as a 4th or 5th dose after DTPa or DTPw priming. Over 99% vaccines developed antibody levels considered to be protective to diphtheria, tetanus and poliovirus, and >95% mounted a response to acellular pertussis antigens. Rectal temperature >39.5 degrees C was observed in at most 3.2% of vaccinees. Swelling >50 mm occurred in 24% of DTPa-primed compared to 5.5% of DTPw-primed children. Large swelling involving the entire upper arm (extending to involve the elbow joint) was reported for up to 1.2% of DTPa-primed subjects, which is consistent with literature reports for other DTPa vaccines.
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| 3. |
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| 4. |
- Renman, C., et al.
(författare)
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Mental health and psychosocial characteristics in adolescent obesity : population-based case-control study
- 1999
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Ingår i: Acta Paediatrica. - : Wiley. - 0803-5253 .- 1651-2227. ; 88:9, s. 998-1003
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Tidskriftsartikel (refereegranskat)abstract
- In this population-based study we compared self-esteem, social background, social and academic competence, behavioural problems and lifestyle in 58 obese adolescents (BMI ≥ 99.6th percentile or ≥ 30 kg/m2), aged 14—18 y, with 58 sex- and age-matched controls of normal weight. The instruments used were: I Think I Am, Youth Self Report and a lifestyle questionnaire. The obese group was on average, 40 kg heavier than the controls. The obese individuals rated themselves significantly lower in physical characteristics, but in all other aspects of self-esteem, mental health and social and academic competence there were no differences between the two groups. There were significant socioeconomic differences, with more obese adolescents living with only one parent and with the mothers in the obese group having, in general, lower education than those in the control group. This study confirms previous observations that obesity is associated with special socioeconomic conditions in youth, but that obese adolescents do not differ from their normal-weight peers in other aspects of mental health
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