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Research Paper

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

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Pages 1903-1909 | Received 11 Mar 2013, Accepted 24 May 2013, Published online: 19 Jun 2013

References

  • IAP Committee on Immunization 2009-2011. In:Yewale V, Choudhury P,Thacker N, ed(s).IAP guidebook on immunization, Mumbai: Indian Academy of Pediatrics, 2011:1-180.
  • Combination vaccines for childhood immunization. MMWR Recomm Rep 1999; 48:RR-5 1 - 14; PMID: 10353568
  • Combination vaccines for childhood immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). Pediatrics 1999; 103:1064 - 77; http://dx.doi.org/10.1542/peds.103.5.1064; PMID: 10224194
  • Schmid DA, Macura-Biegun A, Rauscher M. Development and introduction of a ready-to-use pediatric pentavalent vaccine to meet and sustain the needs of developing countries--Quinvaxem®: the first 5 years. Vaccine 2012; 30:6241 - 8; http://dx.doi.org/10.1016/j.vaccine.2012.07.088; PMID: 22889824
  • World Health Organization. WHO Prequalified Vaccines, Available at: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/ Accessed Nov 20, 2012.
  • Botet Asensi FI, Veronese A, Del Carmen Otero M, Desamparados Tamarit Pérez M, Hontangas Lopez JL, Viviani S. Immunogenicity and safety in infants of a DTwPHib full liquid vaccine. Acta Paediatr 2003; 92:541 - 5; http://dx.doi.org/10.1111/j.1651-2227.2003.tb02503.x; PMID: 12839281
  • Kanra G, Kara A, Demiralp O, Contorni M, Hilbert AK, Spyr C, et al. Safety and immunogenicity of a new fully liquid DTPw-HepB-Hib combination vaccine in infants. Hum Vaccin 2006; 2:155 - 60; http://dx.doi.org/10.4161/hv.2.4.2942; PMID: 17012890
  • Tamm E, Veronese A, Contorni M, Meriste S, Nacci P, Viviani S. Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxem) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate. Vaccine 2005; 23:1715 - 9; http://dx.doi.org/10.1016/j.vaccine.2004.09.028; PMID: 15705477
  • Suárez E, Asturias EJ, Hilbert AK, Herzog C, Aeberhard U, Spyr C. A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador. Rev Panam Salud Publica 2010; 27:117 - 24; http://dx.doi.org/10.1590/S1020-49892010000200005; PMID: 20339615
  • Aspinall S, Traynor D, Bedford P, Hartmann K. Lot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib vaccine Quinvaxem (®) demonstrating clinical equivalence, suitability of the vaccine as a booster and concomitant administration with measles vaccine. Hum Vaccin Immunother 2012; 8:1109 - 18; http://dx.doi.org/10.4161/hv.21095; PMID: 22854660
  • Gentile A, Umido V, Czerniuk P, Nacul J, Seigelchifer M, Hilbert AK, et al. Immunogenicity and reactogenicity of a combined fully liquid DTPw-HepB-Hib pentavalent vaccine in healthy infants: no clinically relevant impact of a birth dose of hepatitis B vaccine. Int J Infect Dis 2011; 15:e24 - 9; http://dx.doi.org/10.1016/j.ijid.2010.09.004; PMID: 21093342
  • Sharma H, Yadav S, Lalwani S, Gupta V, Kapre S, Jadhav S, et al. A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw-HBV-Hib, a liquid pentavalent vaccine in Indian infants. Vaccine 2011; 29:2359 - 64; http://dx.doi.org/10.1016/j.vaccine.2011.01.054; PMID: 21288803
  • Sharma HJ, Yadav S, Lalwani SK, Kapre SV, Jadhav SS, Chakravarty A, et al. Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children. Hum Vaccin 2011; 7:451 - 7; http://dx.doi.org/10.4161/hv.7.4.14208; PMID: 21403463
  • Chatterjee S, Rego SJ, D’Souza F, Bhatia BD, Collard A, Datta SK, et al. The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule. BMC Infect Dis 2010; 10:298; http://dx.doi.org/10.1186/1471-2334-10-298; PMID: 20950457
  • Ali SS, Chandrashekar SR, Singh M, Bansal RK, Sharma DR, Arora D. A multicenter, prospective, open-label, non-comparative study to evaluate the immunogenicity and tolerance of a new, fully liquid pentavalent vaccine (DTwP-HepB-Hib vaccine). Hum Vaccin 2007; 3:116 - 20; http://dx.doi.org/10.4161/hv.3.4.4061; PMID: 17617743
  • Bavdekar SB, Maiya PP, Subba Rao SD, Datta SK, Bock HL. Immunogenicity and safety of combined diphtheria tetanus whole cell pertussis hepatitis B/ Haemophilus influenzae type b vaccine in Indian infants. Indian Pediatr 2007; 44:505 - 10; PMID: 17684303
  • Rao R, Dhingra MS, Bavdekar S, Behera N, Daga SR, Dutta AK, et al. A comparison of immunogenicity and safety of indigenously developed liquid (DTwPHB-Hib) pentavalent combination vaccine (Shan 5) with Easyfive (liq) and TritanrixHB + Hiberix (lyo) in Indian infants administered according to the EPI schedule. Hum Vaccin 2009; 5:425 - 9; PMID: 19333002
  • Cherry JD. Historical review of pertussis and the classical vaccine. J Infect Dis 1996; 174:Suppl 3 S259 - 63; http://dx.doi.org/10.1093/infdis/174.Supplement_3.S259; PMID: 8896526
  • World Health Organization (WHO). Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2010; 85:385 - 400; PMID: 20939150
  • Cherry JD. Why do pertussis vaccines fail?. Pediatrics 2012; 129:968 - 70; http://dx.doi.org/10.1542/peds.2011-2594; PMID: 22529282
  • California Department of Public Health. Immunization Branch. Pertussis report. April 13, 2011. Available at: www.cdph.ca.gov. Accessed Nov 20, 2012.
  • Deinhardt F, Zuckerman AJ. Immunization against hepatitis B: report on a WHO meeting on viral hepatitis in Europe. J Med Virol 1985; 17:209 - 17; http://dx.doi.org/10.1002/jmv.1890170302; PMID: 4067587
  • von Hunolstein C, Aggerbeck H, Andrews N, Berbers G, Fievet-Groyne F, Maple PA, et al. European sero-epidemiology network: standardisation of the results of diphtheria antitoxin assays. Vaccine 2000; 18:3287 - 96; http://dx.doi.org/10.1016/S0264-410X(00)00125-0; PMID: 10869774
  • World Health Organization (WHO). . The immunological basis for immunization series. module 3: Tetanus. 2006.
  • Mariani M, Luzzi E, Proietti D, Mancianti S, Casini D, Costantino P, et al. A competitive enzyme-linked immunosorbent assay for measuring the levels of serum antibody to Haemophilus influenzae type b. Clin Diagn Lab Immunol 1998; 5:667 - 74; PMID: 9729534
  • Mertsola J, Ruuskanen O, Kuronen T, Meurman O, Viljanen MK. Serologic diagnosis of pertussis: evaluation of pertussis toxin and other antigens in enzyme-linked immunosorbent assay. J Infect Dis 1990; 161:966 - 71; http://dx.doi.org/10.1093/infdis/161.5.966; PMID: 2324547

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