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
Bibliographic record
Abstract
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. …
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".