Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study

References

• O’Brien KL, Wolfson LJ, Watt JP, Henkle E, Deloria-Knoll M, McCall N, et al, Hib and Pneumococcal Global Burden of Disease Study Team. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 2009; 374:893 - 902; http://dx.doi.org/10.1016/S0140-6736(09)61204-6; PMID: 19748398
   PubMed Web of Science ®Google Scholar
• Lin TY, Shah NK, Brooks D, Garcia CS. Summary of invasive pneumococcal disease burden among children in the Asia-Pacific region. Vaccine 2010; 28:7589 - 605; http://dx.doi.org/10.1016/j.vaccine.2010.07.053; PMID: 20674872
   PubMed Web of Science ®Google Scholar
• Shah AS, Nisarga R, Ravi Kumar KL, Hubler R, Herrera G, Kilgore PE. Establishment of population-based surveillance for invasive pneumococcal disease in Bangalore, India. Indian J Med Sci 2009; 63:498 - 507; http://dx.doi.org/10.4103/0019-5359.58879; PMID: 20075551
   PubMedGoogle Scholar
• Klugman K, Tam JS. Pneumococcal conjugate vaccine in Asia and the Pacific: Conference report. Vaccine 2001; 19:4579 - 87; http://dx.doi.org/10.1016/S0264-410X(01)00256-0; PMID: 11729814
   PubMedGoogle Scholar
• Berkley JA, Lowe BS, Mwangi I, Williams T, Bauni E, Mwarumba S, et al. Bacteremia among children admitted to a rural hospital in Kenya. N Engl J Med 2005; 352:39 - 47; http://dx.doi.org/10.1056/NEJMoa040275; PMID: 15635111
   PubMed Web of Science ®Google Scholar
• Brent AJ, Ahmed I, Ndiritu M, Lewa P, Ngetsa C, Lowe B, et al. Incidence of clinically significant bacteraemia in children who present to hospital in Kenya: community-based observational study. Lancet 2006; 367:482 - 8; http://dx.doi.org/10.1016/S0140-6736(06)68180-4; PMID: 16473125
   PubMed Web of Science ®Google Scholar
• Sigaúque B, Roca A, Mandomando I, Morais L, Quintó L, Sacarlal J, et al. Community-acquired bacteremia among children admitted to a rural hospital in Mozambique. Pediatr Infect Dis J 2009; 28:108 - 13; http://dx.doi.org/10.1097/INF.0b013e318187a87d; PMID: 19131902
   PubMed Web of Science ®Google Scholar
• Brooks WA, Breiman RF, Goswami D, Hossain A, Alam K, Saha SK, et al. Invasive pneumococcal disease burden and implications for vaccine policy in urban Bangladesh. Am J Trop Med Hyg 2007; 77:795 - 801; PMID: 17984328
   PubMed Web of Science ®Google Scholar
• Arifeen SE, Saha SK, Rahman S, Rahman KM, Rahman SM, Bari S, et al. Invasive pneumococcal disease among children in rural Bangladesh: results from a population-based surveillance. Clin Infect Dis 2009; 48:Suppl 2 S103 - 13; http://dx.doi.org/10.1086/596543; PMID: 19191605
   PubMed Web of Science ®Google Scholar
• Park IH, Pritchard DG, Cartee R, Brandao A, Brandileone MC, Nahm MH. Discovery of a new capsular serotype (6C) within serogroup 6 of Streptococcus pneumoniae. J Clin Microbiol 2007; 45:1225 - 33; http://dx.doi.org/10.1128/JCM.02199-06; PMID: 17267625
   PubMed Web of Science ®Google Scholar
• GAVI's PneumoADIP. Pneumococcal Regional Serotype Distribution for Pneumococcal AMC TPP. Department of International Health Johns Hopkins Bloomberg School of Public Health. 30-11-2008; 1-36.
   Google Scholar
• Leibovitz E, Jacobs MR, Dagan R. Haemophilus influenzae: a significant pathogen in acute otitis media. Pediatr Infect Dis J 2004; 23:1142 - 52; PMID: 15626953
   PubMed Web of Science ®Google Scholar
• Bluestone CD. Clinical course, complications and sequelae of acute otitis media. Pediatr Infect Dis J 2000; 19:Suppl S37 - 46; http://dx.doi.org/10.1097/00006454-200005001-00007; PMID: 10821471
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Yothers G, Dagan R, Kilpi T, Pelton SI, Cohen R, et al. Multinational study of pneumococcal serotypes causing acute otitis media in children. Pediatr Infect Dis J 2002; 21:1008 - 16; http://dx.doi.org/10.1097/00006454-200211000-00007; PMID: 12442021
   PubMed Web of Science ®Google Scholar
• Cherian T, Bhattacharji S, Brahmadathan KN, Lalitha MK, Raghupathy P, Steinhoff MC. Persistent rhinorrhoea in rural Indian children: prevalence and consequences. J Trop Pediatr 2000; 46:365 - 7; http://dx.doi.org/10.1093/tropej/46.6.365; PMID: 11191150
   PubMed Web of Science ®Google Scholar
• Adam D. Global antibiotic resistance in Streptococcus pneumoniae. J Antimicrob Chemother 2002; 50:Suppl 1 - 5; http://dx.doi.org/10.1093/jac/dkf801; PMID: 12077153
   PubMedGoogle Scholar
• World Health Organisation. Pneumococcal conjugate vaccine for childhood immunization--WHO position paper. Wkly Epidemiol Rec 2007; 82:93 - 104; PMID: 17380597
   PubMedGoogle Scholar
• Jain A, Kumar P, Awasthi S. High nasopharyngeal carriage of drug resistant Streptococcus pneumoniae and Haemophilus influenzae in North Indian schoolchildren. Trop Med Int Health 2005; 10:234 - 9; http://dx.doi.org/10.1111/j.1365-3156.2004.01379.x; PMID: 15730507
   PubMed Web of Science ®Google Scholar
• Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 2006; 367:740 - 8; http://dx.doi.org/10.1016/S0140-6736(06)68304-9; PMID: 16517274
   PubMed Web of Science ®Google Scholar
• Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, et al. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J 2009; 28:Suppl S109 - 18; http://dx.doi.org/10.1097/INF.0b013e318199f62d; PMID: 19325447
   PubMed Web of Science ®Google Scholar
• Bermal N, Szenborn L, Chrobot A, Alberto E, Lommel P, Gatchalian S, et al. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J 2009; 28:Suppl S89 - 96; http://dx.doi.org/10.1097/INF.0b013e318199f901; PMID: 19325451
   PubMed Web of Science ®Google Scholar
• Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsène J-P, et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J 2009; 28:Suppl S66 - 76; http://dx.doi.org/10.1097/INF.0b013e318199f8ef; PMID: 19325449
   PubMed Web of Science ®Google Scholar
• Wysocki J, Tejedor JC, Grunert D, Konior R, Garcia-Sicilia J, Knuf M, et al. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J 2009; 28:Suppl S77 - 88; http://dx.doi.org/10.1097/INF.0b013e318199f609; PMID: 19325450
   PubMed Web of Science ®Google Scholar
• Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J 2009; 28:Suppl S97 - 108; http://dx.doi.org/10.1097/INF.0b013e318199f61b; PMID: 19325452
   PubMed Web of Science ®Google Scholar
• WHO. Pertussis vaccines--WHO position paper. Wkly Epidemiol Rec 2005; 80:31 - 9; PMID: 15717398
   PubMedGoogle Scholar
• Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, et al. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health 2011; 11:882; http://dx.doi.org/10.1186/1471-2458-11-882; PMID: 22112189
   PubMed Web of Science ®Google Scholar
• Puumalainen T, Dagan R, Wuorimaa T, Zeta-Capeding R, Lucero M, Ollgren J, et al. Greater antibody responses to an eleven valent mixed carrier diphtheria- or tetanus-conjugated pneumococcal vaccine in Filipino than in Finnish or Israeli infants. Pediatr Infect Dis J 2003; 22:141 - 9; http://dx.doi.org/10.1097/01.inf.0000050459.74134.d5; PMID: 12586978
   PubMed Web of Science ®Google Scholar
• Dagan R, Givon-Lavi N, Greenberg D, Fritzell B, Siegrist CA. Nasopharyngeal carriage of Streptococcus pneumoniae shortly before vaccination with a pneumococcal conjugate vaccine causes serotype-specific hyporesponsiveness in early infancy. J Infect Dis 2010; 201:1570 - 9; http://dx.doi.org/10.1086/652006; PMID: 20384496
   PubMed Web of Science ®Google Scholar
• Rodenburg GD, van Gils EJ, Veenhoven RH, Bogaert D, van den Dobbelsteen GP, Berbers GA, et al. Lower immunoglobulin G antibody responses to pneumococcal conjugate vaccination at the age of 2 years after previous nasopharyngeal carriage of Streptococcus pneumoniae. J Pediatr 2011; 159:965 - 70, e1; http://dx.doi.org/10.1016/j.jpeds.2011.06.011; PMID: 21813135
   PubMed Web of Science ®Google Scholar
• Madhi SA, Violari A, Klugman KP, Lin G, McIntyre JA, von Gottberg A, et al, CIPRA 4 team. Inferior quantitative and qualitative immune responses to pneumococcal conjugate vaccine in infants with nasopharyngeal colonization by Streptococcus pneumoniae during the primary series of immunization. Vaccine 2011; 29:6994 - 7001; http://dx.doi.org/10.1016/j.vaccine.2011.07.035; PMID: 21787822
   PubMed Web of Science ®Google Scholar
• Väkeväinen M, Soininen A, Lucero M, Nohynek H, Auranen K, Mäkelä PH, et al, ARIVAC Consortium. Serotype-specific hyporesponsiveness to pneumococcal conjugate vaccine in infants carrying pneumococcus at the time of vaccination. J Pediatr 2010; 157:778 - 83, e1; http://dx.doi.org/10.1016/j.jpeds.2010.04.071; PMID: 20547399
   PubMed Web of Science ®Google Scholar
• Obaro SK, Steinhoff MC, Shahid N, Siber G. Serum, breast milk, and infant antibody after maternal immunisation with pneumococcal vaccine. Lancet 1996; 347:192 - 3; http://dx.doi.org/10.1016/S0140-6736(96)90376-1; PMID: 8544562
   PubMed Web of Science ®Google Scholar
• Levine OS, Cherian T. Pneumococcal vaccination for Indian children. Indian Pediatr 2007; 44:491 - 6; PMID: 17684301
   PubMed Web of Science ®Google Scholar
• Kilpi T, Ahman H, Jokinen J, Lankinen KS, Palmu A, Savolainen H, et al, Finnish Otitis Media Study Group. Protective efficacy of a second pneumococcal conjugate vaccine against pneumococcal acute otitis media in infants and children: randomized, controlled trial of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine in 1666 children. Clin Infect Dis 2003; 37:1155 - 64; http://dx.doi.org/10.1086/378744; PMID: 14557958
   PubMed Web of Science ®Google Scholar
• Eskola J, Kilpi T, Palmu A, Jokinen J, Haapakoski J, Herva E, et al, Finnish Otitis Media Study Group. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med 2001; 344:403 - 9; http://dx.doi.org/10.1056/NEJM200102083440602; PMID: 11172176
   PubMed Web of Science ®Google Scholar
• Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, et al, Northern California Kaiser Permanente Vaccine Study Center Group. Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J 2000; 19:187 - 95; http://dx.doi.org/10.1097/00006454-200003000-00003; PMID: 10749457
   PubMed Web of Science ®Google Scholar
• Kyaw MH, Lynfield R, Schaffner W, Craig AS, Hadler J, Reingold A, et al, Active Bacterial Core Surveillance of the Emerging Infections Program Network. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant Streptococcus pneumoniae. N Engl J Med 2006; 354:1455 - 63; http://dx.doi.org/10.1056/NEJMoa051642; PMID: 16598044
   PubMed Web of Science ®Google Scholar
• Knuf M, Habermehl P, Cimino C, Petersen G, Schmitt HJ. Immunogenicity, reactogenicity and safety of a 7-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a DTPa-HBV-IPV/Hib combination vaccine in healthy infants. Vaccine 2006; 24:4727 - 36; http://dx.doi.org/10.1016/j.vaccine.2006.03.032; PMID: 16616973
   PubMed Web of Science ®Google Scholar
• Olivier C, Belohradsky BH, Stojanov S, Bonnet E, Petersen G, Liese JG. Immunogenicity, reactogenicity, and safety of a seven-valent pneumococcal conjugate vaccine (PCV7) concurrently administered with a fully liquid DTPa-IPV-HBV-Hib combination vaccine in healthy infants. Vaccine 2008; 26:3142 - 52; http://dx.doi.org/10.1016/j.vaccine.2007.11.096; PMID: 18502545
   PubMed Web of Science ®Google Scholar
• Schmitt HJ, Faber J, Lorenz I, Schmöle-Thoma B, Ahlers N. The safety, reactogenicity and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) concurrently administered with a combination DTaP-IPV-Hib vaccine. Vaccine 2003; 21:3653 - 62; http://dx.doi.org/10.1016/S0264-410X(03)00389-X; PMID: 12922095
   PubMed Web of Science ®Google Scholar
• Tichmann-Schumann I, Soemantri P, Behre U, Disselhoff J, Mahler H, Maechler G, et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate Vaccine. Pediatr Infect Dis J 2005; 24:70 - 7; http://dx.doi.org/10.1097/01.inf.0000148923.46453.48; PMID: 15665713
   PubMed Web of Science ®Google Scholar
• Lagos R, Hoffenbach A, Scemama M, Dupuy M, Schodel F, Hessel L, et al. Lot-to-lot consistency of a combined hexavalent diptheria-tetanus-acellular-pertussis, hepatitis B, Inactivated polio and haemophilus B conjugate vaccine, administered to healthy chilean infants at two, four and six months of age. Hum Vaccin 2005; 1:112 - 7; http://dx.doi.org/10.4161/hv.1.3.1848; PMID: 17012870
   PubMed Web of Science ®Google Scholar
• Prymula R, Plisek S. Clinical experience with DTPw-HBV and DTPw-HBV/Hib combination vaccines. Expert Opin Biol Ther 2008; 8:503 - 13; http://dx.doi.org/10.1517/14712598.8.4.503; PMID: 18352853
   PubMed Web of Science ®Google Scholar
• Concepcion NF, Frasch CE. Pneumococcal type 22f polysaccharide absorption improves the specificity of a pneumococcal-polysaccharide enzyme-linked immunosorbent assay. Clin Vaccine Immunol 2001; 8:266 - 72; http://dx.doi.org/10.1128/CDLI.8.2.266-272.2001
   Web of Science ®Google Scholar
• Poolman JT, Frasch CE, Käyhty H, Lestrate P, Madhi SA, Henckaerts I. Evaluation of pneumococcal polysaccharide immunoassays using a 22F adsorption step with serum samples from infants vaccinated with conjugate vaccines. Clin Vaccine Immunol 2010; 17:134 - 42; http://dx.doi.org/10.1128/CVI.00289-09; PMID: 19889940
   PubMed Web of Science ®Google Scholar
• Henckaerts I, Durant N, De Grave D, Schuerman L, Poolman J. Validation of a routine opsonophagocytosis assay to predict invasive pneumococcal disease efficacy of conjugate vaccine in children. Vaccine 2007; 25:2518 - 27; http://dx.doi.org/10.1016/j.vaccine.2006.09.029; PMID: 17034907
   PubMed Web of Science ®Google Scholar
• Romero-Steiner S, Frasch CE, Carlone G, Fleck RA, Goldblatt D, Nahm MH. Use of opsonophagocytosis for serological evaluation of pneumococcal vaccines. Clin Vaccine Immunol 2006; 13:165 - 9; http://dx.doi.org/10.1128/CVI.13.2.165-169.2006; PMID: 16467321
   PubMed Web of Science ®Google Scholar
• Rose CE, Romero-Steiner S, Burton RL, Carlone GM, Goldblatt D, Nahm MH, et al. Multilaboratory comparison of Streptococcus pneumoniae opsonophagocytic killing assays and their level of agreement for the determination of functional antibody activity in human reference sera. Clin Vaccine Immunol 2011; 18:135 - 42; http://dx.doi.org/10.1128/CVI.00370-10; PMID: 21084458
   PubMed Web of Science ®Google Scholar
• Camargo ME, Silveira L, Furuta JA, Oliveira EP, Germek OA. Immunoenzymatic assay of anti-diphtheric toxin antibodies in human serum. J Clin Microbiol 1984; 20:772 - 4; PMID: 6386879
   PubMed Web of Science ®Google Scholar
• Melville-Smith ME, Seagroatt VA, Watkins JT. A comparison of enzyme-linked immunosorbent assay (ELISA) with the toxin neutralization test in mice as a method for the estimation of tetanus antitoxin in human sera. J Biol Stand 1983; 11:137 - 44; http://dx.doi.org/10.1016/S0092-1157(83)80038-9; PMID: 6345548
   PubMedGoogle Scholar
• Eskola J, Ward J, Dagan R, Goldblatt D, Zepp F, Siegrist CA. Combined vaccination of Haemophilus influenzae type b conjugate and diphtheria-tetanus-pertussis containing acellular pertussis. Lancet 1999; 354:2063 - 8; http://dx.doi.org/10.1016/S0140-6736(99)04377-9; PMID: 10636384
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR United States 1991; 40:1 - 25
   Google Scholar
• World Health Organization (WHO). Progress in the control of viral hepatitis: memorandum from a WHO meeting. Bull World Health Organ 1988; 66:443 - 55; PMID: 2971466
   PubMed Web of Science ®Google Scholar