Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series

Autor: Christine Sadorge, Stéphane Thomas, Stephen M. Hughes, Saul N. Faust, Richard Tomlinson, Rebecca Mann, Shyam Bhakthavalsala, Paul T. Heath, Florence Boisnard, Jennifer Oliver, Ray Borrow, Matthew D. Snape, Peter Rudd, Adam Finn
Jazyk: angličtina
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Meningococcal Vaccines
Serogroup
medicine.disease_cause
immunization
Measles
complex mixtures
Pneumococcal conjugate vaccine
03 medical and health sciences
Rubella vaccine
0302 clinical medicine
antigen
children
030225 pediatrics
Internal medicine
vaccine
medicine
Animals
Humans
Vaccines
Combined
030212 general & internal medicine
Adverse effect
Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
combination
Vaccines
Conjugate
General Veterinary
General Immunology and Microbiology
Tetanus
business.industry
Poliovirus
Diphtheria
Haemophilus influenzae type b
Public Health
Environmental and Occupational Health
Infant
food and beverages
medicine.disease
Antibodies
Bacterial
Poliovirus Vaccine
Inactivated
Infectious Diseases
Hib vaccine
meningococcus
Molecular Medicine
Rabbits
business
medicine.drug
Zdroj: Oliver, J L, Sadorge, C, Boisnard, F, Snape, M D, Tomlinson, R, Mann, R, Rudd, P, Bhakthavalsala, S, Faust, S N, Heath, P T, Hughes, S M, Borrow, R, Thomas, S & Finn, A 2020, ' Randomized clinical trial of DTaP5-HB-IPV-Hib vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during the primary infant series ', Vaccine, vol. 38, no. 35, pp. 5718-5725 . https://doi.org/10.1016/j.vaccine.2020.06.015
ISSN: 1873-2518
DOI: 10.1016/j.vaccine.2020.06.015
Popis: Background: Concomitant administration of vaccines simplifies delivery. DTaP5-HB-IPV-Hib is a fully liquid, combination vaccine against 6 diseases. This study evaluated the compatibility of DTaP5-HB-IPV-Hib with 2 different meningococcus group C conjugate (MCC) vaccines in infants.Methods: In a phase 3, open-label study, 284 healthy infants from 11 UK centres received DTaP5-HB-IPV-Hib at age 2, 3, and 4 months; 13-valent pneumococcal conjugate vaccine (PCV13) at 2 and 4 months; a Haemophilus influenzae type b (Hib)-MCC vaccine and a measles/mumps/rubella vaccine at 12 months. Participants were randomised 1:1 to receive either an MCC-detoxified tetanus toxin vaccine (MCC-TT; n = 141) or an MCC-Corynebacterium diphtheriae CRM197 protein vaccine (MCC-CRM; n = 143) at 3 and 4 months. The primary outcome was seroprotection rate (SPR) to MCC (percent with rabbit complement serum bactericidal antibody titer ≥8).Results: Per protocol analysis, MCC SPRs were 100 and 96.4 one month after the first dose, 100 and 99.1 after the second dose, and 100 and 97.3 after the third (booster) dose of MCC in the MCC-TT and MCC-CRM groups, respectively. One month after all 3 doses of DTaP5-HB-IPV-Hib, immunoglobulin G anti-polyribosylribitol phosphate SPRs (% ≥0.15 µg/mL) were 97.8 in the MCC-TT group and 100 in the MCC-CRM group; anti-hepatitis B antigen SPRs (% ≥10 mIU/mL) were 96.8 and 96.3 in the MCC-TT and MCC-CRM groups, respectively. All participants were seroprotected against diphtheria and tetanus (≥0.01 IU/mL) and poliovirus types 1, 2, and 3 (≥8 dilution), and seroresponse rates to all pertussis antigens were ≥90.4%. Two vaccine-related serious adverse events (transient severe abdominal pain and crying) occurred concomitantly in 1 participant in the MCC-CRM group. Adverse event rates were similar to other studies of DTaP5-HB-IPV-Hib, with pyrexia ≥38 °C in 10.9% of participants following any dose.Conclusions: DTaP5-HB-IPV-Hib can be effectively used in a 2-, 3-, and 4-month infant priming schedule when given with 2 doses of MCC.
Databáze: OpenAIRE
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