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).
Conclusions: Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.