To evaluate the immunogenicity and safety of a fully liquid, hexavalent diphtheria-tetanus-acellular pertussis–inactivated poliovirus–hepatitis B–Haemophilus influenzae type b (DTaP-IPV-HB-PRP~T) vaccine in Indian infants.
Phase III, single-arm study.
Two tertiary-care hospitals.
177 healthy, 6-week-old infants.
All participants received hepatitis B vaccine and Oral polio vaccine (OPV) at birth and DTaP-IPV-HB-PRP~T at 6, 10, 14 weeks of age.
Main outcome measures
Serum was analyzed for immune responses to all antigens 1 month post-3rd dose; safety was assessed for 30 minutes post-vaccination, and for 7 days (solicited reactions) and 30 days (unsolicited events).
Seroprotection rates were 100% for anti-HB (≥10 mIU/mL), anti-PRP (≥0.15 μg/mL), anti-T (≥0.01 IU/mL), anti-polio 1, 2, and 3 (≥8 [1/dil]), and 99.3% for diphtheria (≥0.01 IU/mL). For the pertussis antigens, vaccine response rate was 93.8% for anti-PT and 99.3% for anti-FHA. 37.9% and 54.6% of participants experienced at least one solicited injection site and systemic reaction, respectively, and 20.3% of participants experienced at least one unsolicited event (none of which was related to the vaccination). Four serious adverse events (including one death) were reported, but none was related to the vaccination.
The fully liquid DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in infants in India when administered in a 6, 10, 14 week schedule along with HB and OPV administered at birth, and was well tolerated.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
This is the net price. Taxes to be calculated in checkout.
WHO. Pertussis vaccines: WHO position paper-September 2015. Wkly Epidemiol Rec. 2015;90:433–58.
WHO. Hepatitis B vaccines. Wkly Epidemiol Rec. 2009;84:405–19.
WHO. Haemophilus influenzae type b (Hib) Vaccination Position Paper-July 2013. Wkly Epidemiol Rec. 2013;88:413–26.
WHO. Polio vaccines: WHO position paper, January 2014. Wkly Epidemiol Rec. 2014;89:73–92.
Decker MD, Edwards KM., Bogaerts, HH. Combination vaccines. In: Plotkin SA, Orenstein, W.A, Offit, P.A, editor. Vaccines. 6th ed. PA, USA: Saunders Co.; 2013. p. 981–1007.
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.
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;28:3595–601.
Lyseng-Williamson KM, PL. DTaP-IPV-Hep B-Hib vaccine (Hexyon®/Haxacima®): A guide to its use in the primary and booster vaccination of infants and toddlers in Europe. Drug Ther Perspect. 2013;29:329–35.
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.
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;31:1255–8.
Capeding MR, Cadorna-Carlos J, Book-Montellano M, Ortiz E. Immunogenicity and safety of a DTaP-IPV//PRP approximately T combination vaccine given with hepatitis B vaccine: A randomized open-label trial. Bull World Health Organ. 2008;86:443–51.
Dutta AK, Verghese VP, Pemde HK, Mathew LG, Ortiz E. Immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type B conjugate combination vaccine (Pentaxim) with hepatitis B vaccine. Indian Pediatr. 2009;46:975–82.
Gylca R, Gylca V, Benes O, Melnic A, Chicu V, Weisbecker C, et al. A new DTPa-HBV-IPV vaccine coadministered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth. Vaccine. 2000;19:825–33.
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;101:126–31.
Indian Academy of Pediatrics. IAP recommended immuni-zation schedule 2013 for children aged 0-18 years (with range) 2013. Available from: http://www.iapindia.org/files/IMM%20Schedule.pdf. Accessed December 05, 2016.
del Canho R, Grosheide PM, Voogd M, Huisman WM, Heijtink RA, Schalm SW. Immunogenicity of 20 micrograms of recombinant DNA hepatitis B vaccine in healthy neonates: a comparison of three different vaccination schemes. J Med Virol. 1993;41:30–4.
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:e249–56.
Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011;30:e68–74.
Pichichero ME, Blatter MM, Reisinger KS, Harrison CJ, Johnson CE, Steinhoff MC, et al. Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussishepatitis B-inactivated poliovirus-Haemophilus influenzae type b combination vaccination. Pediatr Infect Dis J. 2002;21:854–9.
Aquino AG, Brito MG, Doniz CE, Herrera JF, Macias M, Zambrano B, et al. A fully liquid DTaP-IPV-Hep B-PRPT hexavalent vaccine for primary and booster vaccination of healthy Mexican children. Vaccine. 2012;30:6492–500.
Ceyhan M and Santos-Lima E. Immunogenicity and safety of an investigational hexavalent fully liquid DTaPIPV-Hep B-PRP-T vaccine given at 2, 3, 4 months of age with a booster at 15-18 months compared to licensed vaccines in Turkish infants. 5th Asian Congress of Pediatric Infectious Diseases; 23-26 September 2010, Tapiei, Taiwan [Abstract].
Madhi SA, Koen A, Cutland C, Groome M, Santos-Lima E. Antibody persistence and booster vaccination of a fully liquid hexavalent vaccine coadministered with measles/mumps/rubella and varicella vaccines at 15-18 months of age in healthy South African infants. Pediatr Infect Dis J. 2013;32:889–97.
Macias M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, et al. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep BPRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012;31:e126–32.
Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated polio-virus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011;30:e88–96.
About this article
Cite this article
Chhatwal, J., Lalwani, S. & Vidor, E. Immunogenicity and safety of a liquid hexavalent vaccine in Indian infants. Indian Pediatr 54, 15–20 (2017). https://doi.org/10.1007/s13312-017-0989-2
- Diphtheria-Pertussis-Tetanus vaccine
- Haemophilus influenzae
- Hepatitis B
- Vaccination program
WHO Universal Trial Number