SavedAdd your journal

Journals / Turkish Journal of Medical Sciences / 2017 / Cilt: 47 - Sayı: 4

A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers

İnci YILDIRIM
Mehmet CEYHAN
Hasan TEZER
İlker DEVRİM
Emmanuel FEROLDI
Pages
1247–1256
Publication Date
2022-11-05
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

Conclusion: The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

📌 3 Key Takeaways

🎯
Objective & Hypothesis:Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15 18 months were evaluated.
📊
Key Findings & Data:Primary series (no hepatitis B [HB] at birth) of DTaP-IPVHB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPVHB-PRP-T booster were administered.
💡
Conclusion & Impact:Conclusion: The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Domain Parameters

Abstract

Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15 18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPVHB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPVHB-PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports. Results: Postprimary series noninferiority of anti-HB ≥ 10 mIU/mL was demonstrated for the DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-PRP-T than for standalone HB. For each antigen except HB, DTaP-IPV-HB-PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups. Conclusion: The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

🔖

Cite This Article

YILDIRIM, İ., CEYHAN, M., TEZER, H., DEVRİM, İ., FEROLDI, E. (2022). A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Turkish infants and toddlers. Turkish Journal of Medical Sciences, Cilt: 47 - Sayı: 4, 1247–1256. https://ajindex.com/articles/610397

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (13)

  1. Edwards KM and Decker MD. Pertussis vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editor. Vaccines. 6th ed. Philadelphia, PA, USA: Saunders Co.; 2013. pp. 447-492
  2. WHO. Pertussis vaccines: WHO position paper, September 2015. Wkly Epidemiol Rec. 2015; 90: 433-458
  3. WHO. Polio vaccines: WHO position paper, January 2014. Wkly Epidemiol Rec. 2014; 89: 73-92
  4. Plotkin SA, Liese J, Madhi SA, Ortiz E. A DTaP-IPV//PRP~T vaccine (Pentaxim): a review of 16 years’ clinical experience. Expert Rev Vaccines 2011; 10: 981-1005
  5. McCormack PL. DTaP-IPV-Hep B-Hib vaccine (Hexaxim®): a review of its use in primary and booster vaccination. Paediatr Drugs 2013; 15: 59-70
  6. Nunes MC, Madhi SA. Review of a new fully liquid, hexavalent vaccine: Hexaxim. Expert Opin Biol Th 2013; 13: 575-593
  7. Santos-Lima E, B’Chir S, Lane A. Combined immunogenicity data for a new DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) following primary series administration at 2, 4, 6 months of age in Latin America. Vaccine 2013; 31: 1255-1258
  8. Tregnaghi MW, Voelker R, Santos-Lima E, Zambrano B. Immunogenicity and safety of a novel yeast Hansenula polymorpha-derived recombinant Hepatitis B candidate vaccine in healthy adolescents and adults aged 10-45 years. Vaccine 2010; 28: 3595-3601
  9. Decker MD, Edwards KM, Bogaerts HH. Combination vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editor. Vaccines. 6th ed. Philadelphia, PA, USA: Saunders Co.; 2013. pp. 981-1007
  10. Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. Immunogenicity and safety of an acellular pertussis, diphtheria, tetanus, inactivated poliovirus, Hib-conjugate combined vaccine (Pentaxim) and monovalent hepatitis B vaccine at 6, 10 and 14 weeks of age in infants in South Africa. S Afr Med J 2011; 101: 126-131
  11. Aquino AG, Brito MG, Doniz CE, Herrera JF, Macias M, Zambrano B, Plennevaux E, Santos-Lima E. A fully liquid DTaP-IPV-Hep B-PRP-T hexavalent vaccine for primary and booster vaccination of healthy Mexican children. Vaccine 2012; 30: 6492-6500
  12. Kosalaraksa P, Thisyakorn U, Benjaponpitak S, Chokephaibulkit K, Santos-Lima E. Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants. Int J Infect Dis. 2011; 15: e249-256
  13. Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational he