Immunogenicity and Safety of a DTaP-IPV//PRP~T Combination Vaccine Given with Hepatitis B Vaccine: A Randomized Open-Label trial/Immunogenicite et Innocuite D'une Combinaison Vaccinale DTaP-IPV//PRP~T, Administree Avec le Vaccin Contre L'hepatite C: Essai Randomise ouvert/Inmonogenicidad Y Seguridad De Una Combinacion Vacunal DTaP-IPV//PRP~T Admnistrada Con la Vacuna Anti-Hepatitis B: Ensayo Aleatorizado Al Descubierto
Notice bibliographique
Résumé
Introduction original aim of the WHO Expanded Programme on Immunization (EPI) was to protect children against six childhood diseases: tuberculosis, diphtheria, neonatal tetanus, whooping cough, poliomyelitis and measles. Subsequently, others were added, including hepatitis B and Haernaphilus influenze type b. Combination that include several valences help ensure high vaccination coverage. Concerns about the safety and reactogenicity of whole-cell pertussis (wP) led to the development of acellular pertussis (aP) vaccines, comprising purified Bardetella pertussis antigens, which are better tolerated than whole-cell and have similar immunogenicity. (1-3) protective efficacy of aP has been documented in controlled trials. (4-6) Today, they ate used in national immunization programmes in Canada, the United States of America (USA), and various European and Asian countries (e.g. Australia, Japan and the Republic of Korea). (7) A recent WHO position paper on pertussis (8) stated that: The best aP have shown similar protective efficacy as the best wP vaccines and that: all licensed have proved to be highly effective in controlling pertussis in infants and young children. Sanofi pasteur has developed an aP vaccine that contains pertussis toxoid (PT) and filamentous haemagglutinin (FHA) that is used in paediatric combinations with not only diphtheria (D) and tetanus (T) proteins, but also inactivated poliovirus (IPV) vaccine and Haemophilus influenzae type-b capsular polyribosyl-ribitol-phosphate conjugated to tetanus toxoid (PRP-T). Both the PRP-T antigen and the IPV vaccine are WHO prequalified vaccines. (9) DTaP-IPV//PRP-T vaccine (known as Pentaxim[TM] or Pentavac[TM]) used in this study has been evaluated clinically in various trials) (10-14) vaccine was first licensed in European countries in 1997 and is now licensed in approximately 67 countries worldwide. Few data are available on the immunogenicity, reactogenicity and safety of aP combination in many countries that follow EPI immunization schedules. Asa result, the present study was carried out to evaluate these characteristics when the DTaP-IPV// PRP-T vaccine was given to infants at 6, 10 and 14 weeks of age along with concomitant hepatitis B virus vaccination, administered on either of the two WHO-recommended vaccination schedules followed in the Philippines. results were compared with those previously obtained in European infants given the same DTaP-IPV//PRP~T vaccine at 2, 3 and 4 months of age. Methods Study design This randomized controlled open study enrolled infants at three medical centres in Manila, the Philippines: the Research Institute for Tropical Medicine (RITM), the University of the East Ramon Magsaysay Memorial Medical Center, and the Mary Chiles Hospital. ethical review board at each centre approved the protocol. Written informed consent was obtained from infants' parents or legal representatives before enrolment. In addition, mothers of potential study subjects also consented to clinical assessment and blood sampling during the third trimester of pregnancy to test for hepatitis B surface antigen (HBsAg). In those who were seropositive for HBsAg, the hepatitis B e antigen (HBeAg) level was also measured. Subjects study involved healthy full-term infants of [greater than or equal to] 37 weeks gestation who weighed [greater than or equal to] 2.5 kg and whose mother was anti-HBsAg seronegative. All infants received the DTaP-IPW/PRP-T vaccine at 6, 10 and 14 weeks of age. In addition, they were randomized within 24 hours of birth, using a random numbers list, to receive recombinant hepatitis B vaccine at either 0, 6 and 14 weeks (Group A) of 6, 10 and 14 weeks of age (Group B). Infants whose mother was HBsAg-seropositive were not enrolled but were given hepatitis B immunoglobulins and the first dose of the hepatitis B vaccine within 24 hours of birth. …
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,003 | 0,003 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,008 | 0,002 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».