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.
Indian Pediatr
; 58(12): 1131-1135, 2021 Dec 15.
Article
en En
| MEDLINE
| ID: mdl-34939580
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vacunas contra Haemophilus
/
Haemophilus influenzae tipo b
Tipo de estudio:
Clinical_trials
Límite:
Humans
/
Infant
País/Región como asunto:
Asia
Idioma:
En
Revista:
Indian Pediatr
Año:
2021
Tipo del documento:
Article
País de afiliación:
Irán