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.

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). 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.