Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India

• DOI: 10.1016/j.conctc.2019.100321
• Publication Date: 2019-01-09T13:21:35Z
• Authors: Ashish Bavdekar; Nandini Malshe; Latha Ravichandran; Amita Sapru; Anand Kawade; Sanjay Lalwani; Sonali Palkar; Neeta Hanumante; Bhagwat Gunale; Dhananjay Kapse; Amol Chaudhari; Tara Miller; Laura Saganic; Courtney Jarrahian; Sarah McGray; Darin Zehrung; Prasad S. Kulkarni
• Keywords: 0301 basic medicine; Medicine (General); 03 medical and health sciences; R5-920; Article; 3. Good health

We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination infants in India. Goals were to determine whether the seropositivity rate after via disposable-syringe jet injector (DSJI) was non-inferior that needle syringe (N-S), compare safety by two methods.Healthy children received three-dose series vaccine intramuscularly DSJI or N-S beginning at 6-8 weeks age. Immunoglobulin G antibody levels measured ELISA 4-6 third dose. The main secondary endpoint safety, as injection site systemic reactions.The stopped early out caution beyond specified protocol stopping criteria, Data Safety Committee noted higher frequency reactions, especially moderate severe, group. As result, 128 subjects-DSJI group 61; 67-completed study, rather than 340 planned, not sufficiently powered immunogenicity endpoints for groups. Descriptive statistics indicate induced with similar all five antigens. Pentavalent includes whole-cell pertussis an aluminum adjuvant, which may have contributed number local reactions DSJI. caused no serious long-term sequelae, be more acceptable other populations circumstances.US National Institutes Health trials identifier: NCT02409095.