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

The Comparison of the Adverse Events of Pentavalent Vaccine and DPT Vaccine in 2–6 Months Infants in Iran: A National Study

“…The results of these studies show that the most common reported adverse event of the Pentavalent vaccine was localized mild events. A study by the Indian Institute of Serology shows that local reactions to the Pentavalent vaccine included pain, redness and edema in the injection site, and its general systematic reactions were reported to be fever, unusual crying and irritability [25]. Hatami et al in Tehran reported fever as the most common adverse event of the Pentavalent vaccine (71.2%) [13].…”

A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

“…Safety data from these studies showed pain, swelling and erythema as the most commonly reported solicited local reactions, and most frequently reported solicited systemic reactions were fever and irritability comparable with our observations. [12][13][14][15][16][17] For several decades, inactivated whole-cell pertussis vaccines (wP) have been part of national childhood vaccination programs, dramatically reducing the considerable public health impact of pertussis. 18 In most emerging and developing countries, DTP vaccination in infants.…”

“…Although direct comparisons are not possible due to differences in data collection and analysis methods, seroprotection/seroconversion rates and reactogenicity profile were found to be similar to other pentavalent vaccines studied in Indian infants. [12][13][14][15][16][17] This study was designed to assess immunogenicity in terms of accepted seroprotection or seroconversion criteria against all five vaccine antigens one month after the third vaccination, and safety and tolerability after each vaccine dose. The study was conducted according to Good Clinical Practice and in accordance with the Ethical Guidelines for Biomedical Research on Human Subjects and Declaration of Helsinki.…”

Variantes de escape del virus de la hepatitis B

“…Inicialmente la vacuna contra el VHB se administró en forma monovalente; posteriormente con el advenimiento de las vacunas combinadas y con las grandes ventajas que éstas presentan como ampliación en la cobertura de vacunación, se desarrolló una vacuna pentavalente. Se trata de una vacuna que además confiere protección contra las toxinas de Corynebacterium diphtheriae y Clostridium tetani, antígenos de Bordetella pertussis, y polisacárido de Haemophilus influenzae tipo b [18][19] . En 1992, niños entre 0 y 5 años de edad recibieron vacuna recombinante monovalente con un esquema a los 0, 1 y 2 meses.…”