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Immunogenicity and Safety of Primary and Booster Vaccinations of a Fully Liquid DTaP-IPV-HB-PRP-T Hexavalent Vaccine in Healthy Infants and Toddlers in Germany and the Czech Republic
R. Prymula, D. Kieninger, E. Feroldi, E. Jordanov, S. B'Chir, X. DaCosta,
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
- MeSH
- hemofilové vakcíny aplikace a dávkování imunologie MeSH
- imunogenicita vakcíny * MeSH
- kojenec MeSH
- kombinované vakcíny aplikace a dávkování imunologie MeSH
- lidé MeSH
- novorozenec MeSH
- očkovací schéma MeSH
- poliovirová vakcína inaktivovaná aplikace a dávkování imunologie MeSH
- protilátky bakteriální krev MeSH
- protilátky virové krev MeSH
- sekundární imunizace MeSH
- suspenze aplikace a dávkování MeSH
- tetanový toxoid aplikace a dávkování imunologie MeSH
- vakcína proti hepatitidě B aplikace a dávkování imunologie MeSH
- vakcína proti záškrtu, tetanu a černému kašli aplikace a dávkování imunologie MeSH
- vakcinace MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Česká republika MeSH
- Německo MeSH
To support a fully liquid, diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine in Europe using a 2, 3, 4 month primary series and a booster at 11-15 months of age. Phase III, randomized, observer-blind studies in Germany and the Czech Republic. Participants who had not received HB vaccine were randomized to a 2, 3, 4 month primary series of DTaP-IPV-HB-PRP-T (group 1; N = 266) or a reconstituted DTaP-HB-IPV//PRP-T comparator (group 2; N = 263) and a booster of the same vaccine. Pneumococcal vaccine (PCV13) and rotavirus vaccine were coadministered at 2, 3, 4 months, and the booster was coadministered with PCV13. Noninferiority (group 1 versus group 2) was tested postprimary series for seroprotection rates (anti-HB and anti-PRP) and vaccine response rates (anti-pertussis toxin and anti-filamentous hemagglutinin). Safety was assessed by parental reports. Noninferiority was demonstrated with the lower bound of the 95% confidence interval for the difference (group 1 to group 2) being > -10% for each comparison. Primary series immune responses were high for all antigens and similar in each group. Prebooster antibody persistence was good, and there was a strong anamnestic response, both being similar for the investigational and control vaccines. Responses to PCV13 and rotavirus vaccine were similar in each group. There were no safety concerns. These data support the use of the DTaP-IPV-HB-PRP-T vaccine in a 2, 3, 4 month schedule without a birth dose of HB vaccine, with a booster dose in the second year of life administered with routine childhood vaccines.
From the Charles University Faculty of Medicine Hradec Kralove Czech Republic
Citace poskytuje Crossref.org
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