Safety evaluation following immunization of pentavalent vaccine (multi-dose vial): experiences and comparative study
DOI:
https://doi.org/10.18203/2349-3291.ijcp20210107Keywords:
Multi-dose vial, Liquid pentavalent vaccine, Clinical trial, AEFI, Comparison, SafetyAbstract
Background: Combination vaccines have many benefits but sometimes may result in unexpected side effects which may make the vaccine unfit for administration particularly with multidose vials.
Methods: Healthy infants aged 6-8 weeks who came for routine immunization of liquid pentavalent vaccine were included in the study. All infants were observed for 30 minutes, post vaccination. Telephonic interview was conducted to detect AEFIs at 1 week and 1 month post vaccination.
Results: The common AEFIs were found to be fever and pain at injection site. A comparison of the incidence (per 100 doses) of AEFIs after 1st, 2nd and 3rd dose of pentavalent vaccine showed that AEFIs goes on reducing with dose. Incidence (per 100 doses) of fever and local AEFIs was more (statistically significant) with multi-dose vial pentavalent vaccine.
Conclusions: The multi-dose vial liquid pentavalent vaccine was found to be equally tolerable compared to single-dose vial liquid pentavalent vaccine.
References
Vashishtha VM, Kalra A, Bose A, Thacker N, Yewale VN, Bansal CP et al. Indian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP), Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years, India, 2013 and updates on immunization. Indian Pediatr. 2013;50:1095-108.
Sreedhar S, Antony A, Poulose N. Study on the effectiveness and impact of pentavalent vaccination program in India and other south Asian countries. Hum Vaccin Immunother. 2014;10:2062-65.
UNICEF India. 18 Million Indian Children to Receive Life Saving Five-in-One Vaccine GENEVA. 2009. Available from: http://unicef.in/PressReleases/162/18-Million-Indian-Children-to-Receive-Life-Saving-Five in One-Vaccine-. Last accessed on
Dodoo A, Renner L, van Grootheest A, Labadie J, Agyei KOA, Hayibor S et al. Safety Monitoring of a New Pentavalent Vaccine in the Expanded Program on Immunization in Ghana. Drug Saf. 2007;30:347-56.
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.
Schmid D, 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;30:6241-48.
Sharma H, Yadav S, Lalwani S. 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. Human Vaccines. 2011;7:451-7.
Kanra G, Kara A, Demiralp O. Safety and Immunogenicity of a New Fully Liquid DTPw-HepB-Hib Combination Vaccine in Infants. Human Vaccines. 2006;2:155-60.
Global Advisory Committee on Vaccine Safety review of pentavalent vaccine safety concerns in four Asian countries. Report from the12 June2013 meeting. Last accessed on 15 October 2013.
Deshpande R, Ghongane B. Current status of vaccines against Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib: A Review. Research & Reviews: AHMS. 2014;3:5-13.
Kumar A, Garg S, Yadav S. Pharmacovigilance study of vaccine. IJPPS. 2015;4:1187-1201.
Y.Lee B, A. Norman B, Marie Assi T, Chen SI, Bailey RR, Rajgopal J et al. Single versus multi-dose vaccine vials: An economic computational model. Vaccine. 2010;28:5292-300.
Drain PK, Nelson CM, Lloyd JS. Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries. Bull World Health Organ. 2003; 81:726-31.
Kohl KS, Walop W, Gidudu J. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. Vaccine. 2007;25:5858-74.
Rothstein E, Kohl KS, Ball L. Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis and presentation. Vaccine. 2004;22:575-85.
Marcy SM, Kohl KS, Dagan R. Fever as an adverse event following immunization: case definition and guidelines of data collection, analysis and presentation. Vaccine. 2004;22:551-6.
Karami M, Ameri P, Bathaei J. Adverse events following immunization with pentavalent vaccine: experiences of newly introduced vaccine in Iran. BMC Immunol. 2017;18.
Liquid pentavalent combination vaccine (pq_253_254_DTP_HepB_Hib_liquid_BiolE_PI) [package insert]. Hyderabad (Telangana): Biological E Limited; 2014.
