Influence of parenteral administration routes and additional factors on vaccine safety and immunogenicity: A review of recent literature

Expert Review of Vaccines

Volumn 13, Issue 3, 2014, Pages 399-415

  Herzog, Christian ^a  

^a SWISS TROPICAL AND PUBLIC HEALTH INSTITUTE   (Switzerland)

Author keywords

Virosomes

Indexed keywords

ADJUVANTS, IMMUNOLOGIC; ADMINISTRATION, INTRAVENOUS; AGE FACTORS; ANTIBODY FORMATION; BODY MASS INDEX; DRUG ADMINISTRATION ROUTES; FEMALE; HUMANS; INJECTIONS, INTRADERMAL; INJECTIONS, INTRAMUSCULAR; INJECTIONS, SUBCUTANEOUS; MALE; NEEDLES; SEX FACTORS; VACCINATION; VACCINES;

EID: 84894065742     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.2014.883285     Document Type: Review

References (126)

1. Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration? Vaccine 2008;26:3197-208
2. Plotkin SL, Plotkin SA. A short history of vaccination. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th edition Saunders/Elsevier; Philadelphia, PA, USA: 2008
3. Feldmann H. History of injections. Pictures from the history of otorhinolaryngology highlighted by exhibits of the German History of Medicine Museum in Ingolstadt. [Article in German]. Lryngorhinootologie 2000;79:239-46
4. Cook IF. Evidence based route of administration of vaccines. Hum Vaccin 2008;4:67-73
5. Tuft L, Yage E, Rodgers S. Comparative study of the antibody response after various methods of administration of mixed typhoide vaccine. J Infect Dis 1932;5:95; [quoted by Lambert 2008 [1]]
6. Roukens AH, Vossen AC, Bredenbeek PJ, et al. Intradermally administered yellow fever vaccine at reduced dose induces a protective immune response: a randomized controlled non-inferiority trial. PLoS One 2008;3:e1993
7. Nelson KS, Janssen JM, Troy SB, Maldonado Y. Intradermal fractional dose inactivated polio vaccine: a review of the literature. Vaccine 2012;30:121-5
8. Cutts FT, Clements CJ, Bennett JV. Alternative routes of measles immunization: a review. Biologicals 1997;25:323-38
9. Quiambao BP, Dimaano EM, Ambas C, et al. Reducing the cost of post-exposure rabies prophylaxis: efficacy of 0.1 ml PCEC rabies vaccine administered intradermally using the Thai Red Cross post-exposure regimen in patients severely exposed to laboratory-confirmed rabid animals. Vaccine 2005;23:1709-14
10. Pancharoen C, Mekmullica J, Thisyakorn U, et al. Reduced-dose intradermal vaccination against hepatitis A using an aluminium-free vaccine is immunogenic and can lower costs. Clin Infect Dis 2005;41:1537-40
11. Sangaré L, Manhart L, Zehrung D, Wang CC. Intradermal hepatitis B vaccination: a systematic review and meta-analysis. Vaccine 2009;27:1777-86
12. Icardi G, Orsi A, Ceravolo A, Ansaldi F. Current evidence on intradermal influenza vaccines administered by SoluviaTM licensed micro injection system. Hum Vaccin Immunother 2012;8:67-75
13. Teunissen MB, Haniffa M, Collin MP. Insight into the immunobiology of human skin and functional specialization of skin dendritic cell subsets to innovate intradermal vaccination design. Curr Top Microbiol Immunol 2012;351:25-76
14. Kersten G, Hirschberg H. Needle-free vaccine delivery. Expert Opin Drug Deliv 2007;4:459-74
15. Kis EE, Winter G, Myschik J. Devices for intradermal vaccination. Vaccine 2012;30: 523-38
16. Weniger BG, Papania MJ. Alternative vaccine delivery methods. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th Edition Saunders/Elsevier; Philadelphia; PA, USA: 2013. p. 1200-31
17. Zehrung D, Jarrahian C, Wales A. Intradermal delivery for vaccine dose sparing: overview of current issues. Vaccine 2013;31:3392-5
18. Sabin AB. Oral poliovirus vaccine: history of its development and use and current challenge to eliminate poliomyelitis from the world. J Infect Dis 1985;151:420-36
19. Wahdan MH, Serie C, Germanier R, et al. A controlled field trial of life oral typhoid vaccine Ty21a. Bull World Health Organ 1980;58:469-74
20. Sabin AB, Arechiga AF, Fernandez de Castro J, et al. Successful immunization of infants with and without maternal antibody by aerosolized measles vaccine. I. Different results with undiluted human diploid cell and chick embryo fibroblast vaccines. JAMA 1983;240:2651-2
21. Hiremath GS, Omer SB. A meta-analysis of studies comparing the respiratory route with the subcutaneous route of measles vaccine administration. Hum Vaccin 2005;1:30-6
22. Davenport FM, Hennessy AV, Maassab HF, et al. Pilot studies on recombinant cold-adapted live type A and B influenza virus vaccines. J Infect Dis 1977;136:17-25
23. Gniadecka M, Jemec GBE. Quantitative evaluation of chronological aging and photoaging in vivo: studies on skin echogenicity and thickness. Br J Dermatol 1998;139:815-21
24. Rigal JD, Escoffier C, Querleux B, et al. Assessment of aging of human skin by in-vivo ultrasonic imaging. J Invest Dermatol 1989;93:621-5
25. Poland GA, Brud A, Jacobson RM, et al. Determination of deltoid fat pad thickness, implication for needle length in adult immunization. JAMA 1997;277:1709-11
26. Cook IF, Williamson M, Pond D. Definition of needle length required for intramuscular deltoid injection in elderly adults: an ultrasonographic study. Vaccine 2006;24:937-40
27. Atkinson WL, Kroger AL, Pickering LK. General immunization practices. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th edition Saunders/ Elsevier; Philadelphia, PA, USA: 2008
28. Mayorga Pe'rez O, Herzog C, Zellmeyer M, et al. Efficacy of virosome hepatitis A vaccine in toddlers in Nicaragua: randomised placebo-controlled trial. J Infect Dis 2003;188:671-7
29. Bovier PA. Epaxal: a virosomal vaccine to prevent hepatitis A infection. Expert Rev Vaccines 2008;7:1141-50
30. Centers for Disease Control and Prevention. General recommendations on immunization - Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011;60(RR-2):1-60
31. de Lalla F, Rinaldi E, Santoro D, Pravettoni G. Immune response to hepatitis B vaccine given at different injection sites and by different routes: a controlled randomized study. Eur J Epidemiol 1988;4: 256-8
32. Shaw FE Jr, Guess HA, Roets JM, et al. Effect of anatomic injection site, age and smoking on the immune response to hepatitis B vaccination. Vaccine 1989;7: 425-30
33. Fishbein DB, Sawyer LA, Reid-Sanden FL, Weir EH. Administration of human diploid-cell rabies vaccine in the gluteal area. N Engl J Med 1988;318:124-5
34. Jackson LA, Peterson D, Nelson JC, et al. Vaccination site and risk of local reactions in children 1 through 6 years of age. Pediatrics 2013;131:283-9
35. Nirmal S, Cherian T, Samuel BU, et al. Immune response of infants to fractional doses of intradermally administered inactivated poliovirus vaccine. Vaccine 1998;16:928-31
36. Middleman AB, Anding R, Tung C. Effect of needle length when immunizing obese adolescents with hepatitis B vaccine. Pediatrics 2010;e508-12
37. Marshall HS, Clarke MF, Evans S, et al. Randomized trial using ultrasound to assess intramuscular vaccination at a 60° or 90° needle angle. Vaccine 2013;31:2647-52
38. Ajana F, Sana C, Caulin E. Are there differences in immunogenicity and safety of vaccines according to the injection method? (Review) [article in French]. Med Mal Infect 2008;38:648-57
39. Pittman PR. Aluminum-containing vaccine associated adverse events: role of route of administration and gender. Vaccine 2002; 20(Suppl 3):S48-50
40. Petousis-Harris H. Vaccine injection technique and reactogenicity- evidence for practice. Vaccine 2008;26:6299-304
41. Hickling J, Jones R; PATH, WHO. Intradermal delivery of vaccines: a review of the literature and the potential for development for use in low- and middle-income countries. PATH, Seattle; 2009. Available from: http://www.path.org/ publications/detail.php?i=1746 [Last accessed 08 March 2013]
42. Fro?sner G, Steffen R, Herzog C. Virosomal hepatitis A vaccine: comparing intradermal and subcutaneous with intramuscular administration. J Trav Med 2009;16:413-19
43. Ragni MV, Lusher JM, Koerper MA, et al. Safety and immunogenicity of subcutaneous hepatitis A vaccine in children with haemophilia. Haemophilia 2000;6:98-103
44. Fisch A, Cadilhac P, Vidor E, et al. Immunogenicity and safety of a new inactivated hepatitis A vaccine: a clinical trial with comparison of administration route. Vaccine 1996;14:1132-6
45. Taddio A, Ilersich AL, Ipp M, et al. HELPinKIDS Team. Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations: systematic review of randomized controlled trials and quasi-randomized controlled trials. Clin Ther 2009;31(Suppl 2):S48-76
46. Goswani G, Upadhyay A, Gupta NK, et al. Comparison of analgesic effect of direct breastfeeding, oral 25% dextrose solution and placebo during 1st DPT vaccination in healthy term infants: a randomized, placebo controlled trial. Indian Pediatr 2013;50: 649-53
47. Ipp M, Taddio A, Sam J, et al. Vaccine-related pain: randomised controlled trial of two injection techniques. Arch Dis Child 2007;92:1105-8
48. Petousis-Harris H, Poole T, Stewart J, et al. An investigation of three injections techniques in reducing local injection pain with a human papillomavirus vaccine: a randomized trial. Vaccine 2013;31: 1157-62
49. D'Acremont V, Herzog C, Genton B. Immunogenicity and safety of a virosomal hepatitis A vaccine (Epaxal) in the elderly. J Trav Med 2006;13:78-83
50. Linglo?f T, van Hattum J, Kaplan KM, et al. An open study of subcutaneous administration of inactivated hepatitis A vaccine (VAQTA) in adults: safety, tolerability, and immunogenicity. Vaccine 2001;19:3968-7391
51. Brindle RJ, Morris CA, Berger R, Kurtz JB. Inadequate response to intradermal hepatitis A vaccine. Vaccine 1994;12:483-4
52. Carlsson U, Brudin L, Eliasson I, Hansson BG. Hepatitis A vaccination by intracutaneous low dose administration: a less expensive alternative. Scand J Infect Dis 1996;28:435-8
53. Beyer WE, Palache AM, Osterhaus AD. Comparison of serology and reactogenicity between influenza subunit vaccines and whole virus or split vaccines: a review and meta-analysis of the literature. Clin Drug Investig 1998;15:1-12
54. Gillet Y, Habermehl P, Thomas S, et al. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro) and a varicella vaccine (VARIVAX) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med 2009;7:16
55. Cook IF, Barr I, Hartel G, et al. Reactogenicity and immunogenicity of an inactivated influenza vaccine administered by intramuscular or subcutaneous injection in elderly adults. Vaccine 2006;24:2395-402
56. Hung IF, Levin Y, To KK, et al. Dose sparing intradermal trivalent influenza. (2010/2011) vaccination overcomes reduced immunogenicity of the 2009 H1N1 strain. Vaccine 2012;30:6427-35
57. Patel SM, Atmar RL, El Sahly HM, et al. Direct comparison of an inactivated subvirion influenza A virus subtype H5N1 vaccine administered by the intradermal and intramuscular routes. J Infect Dis 2012;206:1069-77
58. Ledgerwood JE, Hu Z, Gordon IJ, et al. Influenza virus h5 DNA vaccination is immunogenic by intramuscular and intradermal routes in humans. Clin Vaccine Immunol 2012;19:1792-7
59. Martins C, Garly ML, Bale C, et al. Measles antibody levels after vaccination with Edmonston-Zagreb and Schwarz measles vaccine at 9 months or at 9 and 18 months of age: a serological study within a randomised trial of different measles vaccines. Vaccine 2013;31:5766-71
60. Georgitis JW, Fasano MB. Allergenic components of vaccines and avoidance of vaccination-related adverse events. Curr Allergy Rep 2001;1:11-17
61. Barbaud A, Deschildre A, Waton J, et al. Hypersensitivity and vaccines: an update. Eur J Dermatol 2013;23:135-41
62. Moser C, Amacker M, Zurbriggen R. Influenza virosomes as a vaccine adjuvant and carrier system. Expert Rev Vaccines 2011;10:437-46
63. Van Der Wielen M, Vertruyen A, Froesner G, et al. Immunogenicity and saftey of a pediatric dose of a virosome-adjuvanted hepatitis A vaccine: a controlled trial in children aged 1-16 years. Pediatr Infect Dis J 2007;26: 705-10
64. Bovier PA, Farinelli T, Loutan L. Interchangeability and tolerability of a virosomal and an aluminium -adsorbed hepatitis A vaccine. Vaccine 2005;23:2422-7
65. Clarke PD, Adams P, Ibanez R, Herzog C. Rate, intensity, and duration of local reactions to a virosome-adjuvanted vs. an aluminium-adsorbed hepatitis A vaccine in UK travellers. Travel Med Infect Dis 2006;4:313-18
66. Hoke CH Jr, Egan JE, Sjogren MH, et al. Administration of hepatitis A vaccine to a military population by needle and jet injector and with hepatitis B vaccine. J Infect Dis 1995;171(Suppl 1):S53-60
67. Williams J, Fox-Leyva L, Christensen C, et al. Hepatitis A vaccine administration: comparison between jet-injector and needle injection. Vaccine 2000;18:1939-43
68. Esposito S, Fumagalli M, Principi N. Immunogenicity, safety and tolerability of vaccinations in premature infants. Expert Rev Vaccines 2012;11:1199-209
69. Grubeck-Loebenstein B. Fading immune protection in old age: vaccination in the elderly. J Comp Pathol 2010;142(Suppl 1): S116-19
70. Giezeman KM, Nauta J, de Bruijn IA, Palache AM. Trivalent inactivated subunit influenza vaccine Influvac: 25-Year experience of safety and immunogenicity. Vaccine 2009;27:2414-17
71. Hatz C, Beck B, Steffen R, et al. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal- in healthy travellers. Vaccine 2011;29:5000-6
72. Monath TP, Nichols R, Archambault WT, et al. Comparative safety and immunogenicity of two yellow fever 17D vaccines (ARILVAX and YF-VAX) in a phase III multicenter, double-blind clinical trial. Am J Trop Med Hyg 2002;66:533-41
73. Pfister M, Ku?rsteiner O, Hilfiker H, et al. Immunogenicity and safety of Berna-YF as compared to two other 17D yellow fever vaccines in a phase 3 clinical trial. Am J Trop Med Hyg 2005;72:339-46
74. Beyer WE, Palache AM, Kerstens R, Masurel N. Gender differences in local and systemic reactions to inactivated influenza vaccine, established by a meta- analysis of fourteen independent studies. Eur J Clin Microbiol Infect Dis 1996;15:65-70
75. Genton B, D'Acremont V, Furrer HJ, et al. Hepatitis A vaccines and the elderly. Travel Med Infect Dis 2006;4:303-12
76. Abarca K, Iba'nez I, de la Fuente P, et al. Immunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1-16 years. Vaccine 2011;29:8855-62
77. Cook IF. Sexual dimorphism of humoral immunity with human vaccines. Vaccine 2008;26:3551-5
78. Cook IF. Sex differences in injection site reactions with human vaccines. Hum Vaccin 2009;5:441-9
79. Jackson LA, Austin G, Chen RT, et al. Safety and immunogenicity of varying dosages of trivalent inactivated influenza vaccine administered by needle-free jet injectors. Vaccine 2001;19:4703-9
80. Engler RJ, Nelson MR, Klote MM, et al. Half- vs full-dose trivalent inactivated influenza vaccine (2004-2005): age, dose, and sex effects on immune responses. Arch Intern Med 2008;168:2405-14
81. Shohat T, Green MS, Nakar O, et al. Gender differences in the reactogenicity of measles-mumps-rubella vaccine. Isr Med Assoc J 2000;2:192-5
82. Reisinger KS, Block SL, Lazcano-Ponce E, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J 2007;26:201-9
83. Bovier PA, Bock J, Ebengo TF, et al. Predicted 30-year protection after vaccination with an aluminum-free virosomal hepatitis A vaccine. J Med Virol 2010;82:1629-34
84. Hatz C, van der Ploeg R, Beck BR, et al. Successful memory response following a booster dose with a virosome-formulated hepatitis a vaccine delayed up to 11 years. Clin Vaccine Immunol 2011;18:885-7
85. Furman D, Hejblum BP, Simon N. Systems analysis of sex differences reveals an immunosuppressive role for testosterone in the response to influenza vaccination. Proc Natl Acad Sci USA 2014;111:869-74
86. Stock NK, Boschetti N, Herzog C, et al. The phylogeny of yellow fever virus 17D vaccines. Vaccine 2012;30:989-94
87. Monath TP. Review of the risks and benefits of yellow fever vaccination including some new analyses. Expert Rev Vaccines 2012;11:427-48
88. King JW, Taylor EM, Crow SD, et al. Comparison of the immunogenicity of hepatitis B vaccine administered intradermally and intramuscularly. Rev Infect Dis 1990;12:1035-43
89. Coleman PJ, Shaw FE Jr, Serovich J, et al. Intradermal hepatitis B vaccination in a large hospital employee population. Vaccine 1991;9:723-7
90. Christy C, Pichichero ME, Reed GF, et al. Effect of gender, race, and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines. Pediatrics 1995;96:584-7
91. Montefiori DC, Metch B, McElrath MJ, et al. Demographic factors that influence the neutralizing antibody response in recipients of recombinant HIV-1 gp120 vaccines. J Infect Dis 2004;190:1962-9
92. Ritz N, Tebruegge M, Camacho-Badilla K, et al. To TST or not to TST: is tuberculin skin testing necessary before BCG immunisation in children? Vaccine 2012;30: 1434-6
93. Olander RM, Auranen K, Harkanen T, Leino T. High tetanus and diphtheria antitoxin concentrations in Finnish adults- time for new booster recommendations? Vaccine 2009;27:5295-8
94. Beck BR, Hatz C, Loutan L, Steffen R. Immunogenicity of booster vaccination with a virosomal hepatitis a vaccine after primary immunization with an aluminum-adsorbed hepatitis a vaccine. J Travel Med 2004;11: 201-7
95. Brinkhof MW, Mayorga O, Bock J, et al. Kinetics of maternally acquired anti-hepatitis A antibodies: prediction of waning based on maternal or cord blood antibody levels. Vaccine 2013;31:1490-5
96. Zaiss AK, Machado HB, Herschman HR. The influence of innate and pre-existing immunity on adenovirus therapy. J Cell Biochem 2009;108:778-90
97. Thacker EE, Timares L, Matthews QL. Strategies to overcome host immunity to adenovirus vectors in vaccine development. Expert Rev Vaccines 2009;8:761-77
98. Penaloza-Macmaster P, Provine NM, Ra J, et al. Alternative serotype adenovirus vaccine vectors elicit memory T cells with enhanced anamnestic capacity compared to ad5 vectors. J Virol 2013;87:1373-84
99. Croyle MA, Patel A, Tran KN, et al. Nasal delivery of an adenovirus-based vaccine bypasses pre-existing immunity to the vaccine carrier and improves the immune response in mice. PLoS One 2008;3:e3548
100. Richardson JS, Abou MC, Tran KN, et al. Impact of systemic or mucosal immunity to adenovirus on Ad-based Ebola virus vaccine efficacy in guinea pigs. J Infect Dis 2011; 204(Suppl 3):S1032-42
101. Choi JH, Schafer SC, Zhang L, et al. A single sublingual dose of an adenovirusbased vaccine protects against lethal Ebola challenge in mice and guinea pigs. Mol Pharm 2012;9:156-67
102. Song K, Bolton DL, Wei CJ, et al. Genetic immunization in the lung induces potent local and systemic immune responses. Proc Natl Acad Sci USA 2010;107:22213-18
103. Siegrist CA. Mechanisms by which maternal antibodies influence infant vaccine responses: review of hypotheses and definition of main determinants. Vaccine 2003;21:3406-12
104. Kim D, Huey D, Oglesbee M, Niewiesk S. Insights into the regulatory mechanism controlling the inhibition of vaccine-induced seroconversion by maternal antibodies. Blood 2011;117:6143-51
105. Low N, Kraemer S, Schneider M, Restrepo AM. Immunogenicity and safety of aerosolized measles vaccine: systematic review and meta-analysis. Vaccine 2008;26: 383-98
106. Siegrist CA. Neonatal and early life vaccinology. Vaccine 2001;19:3331-46
107. World Health Organisation. Polio vaccines and polio immunization in the preeradication era: WHO position paper. Wkly Epidemiol Rec 2010;85:213-28
108. Mohammed AJ, AlAwaidy S, Bawikar S, et al. Fractional doses of inactivated poliovirus vaccine in Oman. N Engl J Med 2010;362:2351-9
109. Resik S, Tejeda A, Lago PM, et al. Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba. J Infect Dis 2010;201:1344-52
110. Cadorna-Carlos J, Vidor E, Bonnet MC. Randomized controlled study of fractional doses of inactivated poliovirus vaccine administered intradermally with a needle in the Philippines. Int J Infect Dis 2012;16: e110-16
111. Aubert A, Naveau S, Poynard T, et al. Evaluation of hepatitis B vaccination in a Paris hospital personnel. 386 subjects [Article in French]. Presse Med 1987;16: 1313-16
112. Descoeudres C. Hepatitis B vaccination [Article in German]. Schweiz Med Wochenschr 1984;114:498-505
113. Kelly K, Loskutov A, Zehrung D, et al. Preventing contamination between injections with multiple-use nozzle needle-free injectors: a safety trial. Vaccine 2008;26: 1344-52
114. Chen X, Wang J, Shah D, Wu MX. An update on the use of laser technology in skin vaccination. Expert Rev Vaccines 2013;12:1313-23
115. Gorres JP, Lager KM, Kong WP, et al. DNA vaccination elicits protective immune responses against pandemic and classic swine influenza viruses in pigs. Clin Vaccine Immunol 2011;18:1987-95
116. Van Damme P, Arnou R, Kafeja F, et al. Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study. BMC Infect Dis 2010;10:134
117. Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, et al. Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults. Vaccine 2009;27:454-9
118. Nelson EA, Lam HS, Choi KC, et al. A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18-26 years. Vaccine 2013;31:3452-60
119. Jarrahian C, Zehrung D, Saxon E, et al. Clinical performance and safety of the ID adapter, a prototype intradermal delivery technology for vaccines, drugs, and diagnostic tests. Procedia Vaccinol 2012;6: 125-33
120. Griffiths UK, Santos AC, Nundy N, et al. Incremental costs of introducing jet injection technology for delivery of routine childhood vaccinations: comparative analysis from Brazil, India, and South Africa. Vaccine 2011;29:969-75
121. Improving the affordability of inactivated poliovirus vaccines (IPV) for use in lowand middle-income countries: an economic analysis of strategies to reduce the cost of routine IPV immunization. Program for Appropriate Technology in Health (PATH), Seattle; 2010. Available from: www.path. org/publications/ details.php?i=1809 [Last accessed 08 March 2013]
122. Poirier MK, Poland GA, Jacobson RM. Parameters potentially affecting interpretation of immunogenicity and efficacy data in vaccine trials: are they adequately reported? Vaccine 1996;14:25-7
123. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332
124. Scott P, Ott F, Egger M, Low N. Completeness of reporting in randomized controlled trials of 3 vaccines: a review of adherence to the CONSORT checklist. Pediatr Infect Dis J 2012;31:1286-94
125. CDC. Prevention of hepatitis A through active or passive immunization - recommendations of the advisory committee on immunization practices (ACIP). MMWR 2006;55(RR-7):1-23
126. WHO. WHO position paper on hepatitis A vaccines -June 2012. Wkly Epidemiol Rec 2012;87:261-76