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Immunogenicity and Safety of Three Who Prequalified (Dtwp -Hb-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase Iii Study Publisher Pubmed



Tabatabaei SR1 ; Karimi A1 ; Zahraei SM2 ; Esteghamati A3 ; Azimi L1 ; Shirvani F1 ; Mohammadi S2 ; Rajabnejad M1 ; Shamshiri A4 ; Faghihian R5 ; Faghihian E6
Authors
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Authors Affiliations
  1. 1. Pediatric Infections Research Center (PIRC), Research Institute for Children’s Health (RICH), Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. Center for Communicable Diseases Control, Ministry of Health and Medical Education, Tehran, Iran
  3. 3. Research Center of Pediatric Infectious Diseases, Institute of Immunology and Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran
  4. 4. Research Centre for Caries Prevention, Dentistry Research Institute, Department of Community Oral Health, School of Dentistry, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Dental Research Center, Department of Pediatric Dentistry, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Department of Pediatric Infectious Disease, Iran University of Medical Sciences, Tehran, Iran

Source: Indian Pediatrics Published:2021


Abstract

Background: The pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014. Objective: To compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.). Design: Randomized, phase III study. Participants: 900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age. Intervention: Infants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups. Outcomes: The antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary. Results: All vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05). Conclusion: Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile. © 2021, Indian Academy of Pediatrics.
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