Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials.
Identifieur interne : 000229 ( Main/Exploration ); précédent : 000228; suivant : 000230Safety and immunogenicity of an AS03-adjuvanted A(H1N1)pmd09 vaccine administered simultaneously or sequentially with a seasonal trivalent vaccine in adults 61 years or older: data from two multicentre randomised trials.
Auteurs : Mathieu Peeters [Belgique] ; Stefan Regner ; Tejaswini Vaman ; Jeanne-Marie Devaster ; Lars RomboSource :
- Vaccine [ 1873-2518 ] ; 2012.
Descripteurs français
- KwdFr :
- Adjuvants immunologiques (administration et posologie), Adulte d'âge moyen, Allemagne, Anticorps antiviraux (sang), Anticorps neutralisants (sang), Calendrier vaccinal, Femelle, Grippe humaine (), Humains, Mâle, Méthode en double aveugle, Méthode en simple aveugle, Sous-type H1N1 du virus de la grippe A, Sujet âgé, Sujet âgé de 80 ans ou plus, Suède, Tests d'inhibition de l'hémagglutination, Vaccination (), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets indésirables), Vaccins inactivés (immunologie).
- MESH :
- administration et posologie : Adjuvants immunologiques, Vaccins antigrippaux, Vaccins inactivés.
- effets indésirables : Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Vaccins antigrippaux, Vaccins inactivés.
- sang : Anticorps antiviraux, Anticorps neutralisants.
- Adulte d'âge moyen, Allemagne, Calendrier vaccinal, Femelle, Grippe humaine, Humains, Mâle, Méthode en double aveugle, Méthode en simple aveugle, Sous-type H1N1 du virus de la grippe A, Sujet âgé, Sujet âgé de 80 ans ou plus, Suède, Tests d'inhibition de l'hémagglutination, Vaccination.
- Wicri :
English descriptors
- KwdEn :
- Adjuvants, Immunologic (administration & dosage), Aged, Aged, 80 and over, Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Double-Blind Method, Female, Germany, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Influenza A Virus, H1N1 Subtype, Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Influenza, Human (prevention & control), Male, Middle Aged, Single-Blind Method, Sweden, Vaccination (methods), Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Adjuvants, Immunologic, Influenza Vaccines, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral.
- chemical , immunology : Influenza Vaccines, Vaccines, Inactivated.
- geographic : Germany, Sweden.
- methods : Vaccination.
- prevention & control : Influenza, Human.
- Aged, Aged, 80 and over, Double-Blind Method, Female, Hemagglutination Inhibition Tests, Humans, Immunization Schedule, Influenza A Virus, H1N1 Subtype, Male, Middle Aged, Single-Blind Method.
Abstract
During the 2009-2010 Northern Hemisphere influenza season, both seasonal and pandemic influenza vaccines were expected to be administered to elderly people, which is an important target group for influenza vaccination. Two multicentre randomised clinical studies were conducted in participants aged ≥61 years to assess the immunogenicity and reactogenicity following vaccination with two doses of an AS03-adjuvanted A(H1N1)pmd09 vaccine when either sequentially administered (21 days before first dose [N=73] or 21 days after second dose [N=72]) or co-administered (first dose [N=84] or second dose [N=84]) with a licensed trivalent seasonal influenza vaccine (TIV). Overall, 313 participants from 2 centres in Sweden (ClinicalTrials.gov, NCT00968890) and 6 centres in Germany (NCT00971425) were randomised to one of the four treatment groups. The AS03-adjuvanted A(H1N1)pmd09 vaccine elicited a good immune response against A(H1N1)pmd09-like virus in all treatment groups after the first and second dose, meeting and exceeding the European licensing criteria for pandemic influenza vaccines. After one dose of the AS03-adjuvanted A(H1N1)pmd09 vaccine, haemagglutination inhibition seroconversion rates ranged from 85% (95% confidence interval: 74-93%) to 93% (85-97%), seroprotection rates from 87% (76-94%) to 96% (90-99%) and geometric mean fold rise from 15 (11-19) to 20 (16-25). The haemagglutination inhibition immune responses to the AS03-adjuvanted A(H1N1)pmd09 vaccine seemed lower when TIV was administered 3 weeks before, while immune responses to TIV seemed not affected by either vaccination schedule. Solicited symptoms were more frequently reported following administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine compared to TIV, but these were mainly mild to moderate in intensity and transient in the four treatment groups. These results suggest that sequential or co-administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine and TIV induced a good immune response to both vaccines and had a clinically acceptable safety profile in people aged ≥61 years.
DOI: 10.1016/j.vaccine.2012.07.081
PubMed: 22885014
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<front><div type="abstract" xml:lang="en">During the 2009-2010 Northern Hemisphere influenza season, both seasonal and pandemic influenza vaccines were expected to be administered to elderly people, which is an important target group for influenza vaccination. Two multicentre randomised clinical studies were conducted in participants aged ≥61 years to assess the immunogenicity and reactogenicity following vaccination with two doses of an AS03-adjuvanted A(H1N1)pmd09 vaccine when either sequentially administered (21 days before first dose [N=73] or 21 days after second dose [N=72]) or co-administered (first dose [N=84] or second dose [N=84]) with a licensed trivalent seasonal influenza vaccine (TIV). Overall, 313 participants from 2 centres in Sweden (ClinicalTrials.gov, NCT00968890) and 6 centres in Germany (NCT00971425) were randomised to one of the four treatment groups. The AS03-adjuvanted A(H1N1)pmd09 vaccine elicited a good immune response against A(H1N1)pmd09-like virus in all treatment groups after the first and second dose, meeting and exceeding the European licensing criteria for pandemic influenza vaccines. After one dose of the AS03-adjuvanted A(H1N1)pmd09 vaccine, haemagglutination inhibition seroconversion rates ranged from 85% (95% confidence interval: 74-93%) to 93% (85-97%), seroprotection rates from 87% (76-94%) to 96% (90-99%) and geometric mean fold rise from 15 (11-19) to 20 (16-25). The haemagglutination inhibition immune responses to the AS03-adjuvanted A(H1N1)pmd09 vaccine seemed lower when TIV was administered 3 weeks before, while immune responses to TIV seemed not affected by either vaccination schedule. Solicited symptoms were more frequently reported following administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine compared to TIV, but these were mainly mild to moderate in intensity and transient in the four treatment groups. These results suggest that sequential or co-administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine and TIV induced a good immune response to both vaccines and had a clinically acceptable safety profile in people aged ≥61 years.</div>
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<Abstract><AbstractText>During the 2009-2010 Northern Hemisphere influenza season, both seasonal and pandemic influenza vaccines were expected to be administered to elderly people, which is an important target group for influenza vaccination. Two multicentre randomised clinical studies were conducted in participants aged ≥61 years to assess the immunogenicity and reactogenicity following vaccination with two doses of an AS03-adjuvanted A(H1N1)pmd09 vaccine when either sequentially administered (21 days before first dose [N=73] or 21 days after second dose [N=72]) or co-administered (first dose [N=84] or second dose [N=84]) with a licensed trivalent seasonal influenza vaccine (TIV). Overall, 313 participants from 2 centres in Sweden (ClinicalTrials.gov, NCT00968890) and 6 centres in Germany (NCT00971425) were randomised to one of the four treatment groups. The AS03-adjuvanted A(H1N1)pmd09 vaccine elicited a good immune response against A(H1N1)pmd09-like virus in all treatment groups after the first and second dose, meeting and exceeding the European licensing criteria for pandemic influenza vaccines. After one dose of the AS03-adjuvanted A(H1N1)pmd09 vaccine, haemagglutination inhibition seroconversion rates ranged from 85% (95% confidence interval: 74-93%) to 93% (85-97%), seroprotection rates from 87% (76-94%) to 96% (90-99%) and geometric mean fold rise from 15 (11-19) to 20 (16-25). The haemagglutination inhibition immune responses to the AS03-adjuvanted A(H1N1)pmd09 vaccine seemed lower when TIV was administered 3 weeks before, while immune responses to TIV seemed not affected by either vaccination schedule. Solicited symptoms were more frequently reported following administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine compared to TIV, but these were mainly mild to moderate in intensity and transient in the four treatment groups. These results suggest that sequential or co-administration of the AS03-adjuvanted A(H1N1)pmd09 vaccine and TIV induced a good immune response to both vaccines and had a clinically acceptable safety profile in people aged ≥61 years.</AbstractText>
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<ArticleIdList><ArticleId IdType="pubmed">22885014</ArticleId>
<ArticleId IdType="pii">S0264-410X(12)01118-8</ArticleId>
<ArticleId IdType="doi">10.1016/j.vaccine.2012.07.081</ArticleId>
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<affiliations><list><country><li>Belgique</li>
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<tree><noCountry><name sortKey="Devaster, Jeanne Marie" sort="Devaster, Jeanne Marie" uniqKey="Devaster J" first="Jeanne-Marie" last="Devaster">Jeanne-Marie Devaster</name>
<name sortKey="Regner, Stefan" sort="Regner, Stefan" uniqKey="Regner S" first="Stefan" last="Regner">Stefan Regner</name>
<name sortKey="Rombo, Lars" sort="Rombo, Lars" uniqKey="Rombo L" first="Lars" last="Rombo">Lars Rombo</name>
<name sortKey="Vaman, Tejaswini" sort="Vaman, Tejaswini" uniqKey="Vaman T" first="Tejaswini" last="Vaman">Tejaswini Vaman</name>
</noCountry>
<country name="Belgique"><noRegion><name sortKey="Peeters, Mathieu" sort="Peeters, Mathieu" uniqKey="Peeters M" first="Mathieu" last="Peeters">Mathieu Peeters</name>
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