Vaccination of adults 65 years of age and older with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Boostrix®): Results of two randomized trials

• Published in: Vaccine Vol. 30; no. 9; pp. 1721 - 1728
• Main Authors: Weston, Wayde M., Friedland, Leonard R., Wu, Xiangfeng, Howe, Barbara
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 21.02.2012; Elsevier Limited
• Subjects: Acellular pertussis vaccine; Age; Aged; Allergy and Immunology; antibodies; Antibodies, Bacterial - blood; Antibodies, Viral - blood; Antigens; children; Confidence intervals; Diphtheria; Diphtheria - prevention & control; Diphtheria toxoid; Diphtheria Toxoid - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - adverse effects; elderly; Elderly vaccination; Humans; immune response; infants; Influenza; Influenza Vaccines - administration & dosage; Influenza Vaccines - adverse effects; Influenza, Human - prevention & control; Licenses; morbidity; Older people; patients; Pertussis vaccination; Postpartum period; Single-Blind Method; Studies; Tdap vaccine; Tetanus; Tetanus - prevention & control; Tetanus toxoid; Tetanus Toxoid - administration & dosage; Vaccination; Vaccines; Vaccines, Acellular - administration & dosage; Whooping cough; Whooping Cough - prevention & control; United States > US; LL; Diphtheria toxoid; D; PT; Tdap vaccine; CI; PRN; GMT; Pertussis vaccination; T; SAE; Tetanus toxoid; Acellular pertussis vaccine; Tdap; HA; GMC; FHA; Elderly vaccination; DTaP; ELISA; geometric mean antibody concentration; diphtheria toxoid; geometric mean antibody titre; paediatric diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine; reduced antigen content tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine; serious adverse event; tetanus toxoid; filamentous haemagglutinin; lower limit; pertactin; viral haemagglutinin; pertussis toxoid; enzyme-linked immunosorbent assay; confidence interval
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2011.12.055

► Pertussis can cause significant morbidity in elderly patients. ► Tdap vaccine (Boostrix®) is immunogenic in subjects ≥65 years. ► The safety profile of Tdap is comparable to that of the US-licensed Td vaccine. Pertussis can cause significant morbidity in elderly patients, who can also transmit this disease to infants and young children. There is little data available on the use of acellular pertussis vaccines in recipients ≥65 years of age. Two studies examined the safety and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine (Boostrix®) in healthy ≥65 year olds. In Study A subjects received single doses of Tdap and seasonal influenza vaccine either co-administered or given one month apart. In Study B subjects received either Tdap or tetanus-diphtheria (Td) vaccine. Antibodies were measured before and one month after vaccination. Reactogenicity and safety were actively assessed using diary cards. A total of 1104 subjects 65 years of age and older received a Tdap vaccination in the two studies. In study A, no differences in immune responses to Tdap or influenza vaccine were observed between co-administered or sequentially administered vaccines. In study B, Tdap was non-inferior to Td with respect to diphtheria and tetanus seroprotection, and anti-pertussis GMCs were non-inferior to those observed in infants following a 3-dose diphtheria, tetanus and acellular pertussis (DTaP) primary vaccination series, in whom efficacy against pertussis was demonstrated. Reports of adverse events were similar between Tdap and Td groups. Tdap was found to be immunogenic in subjects ≥65 years, with a safety profile comparable to US-licensed Td vaccine. Tdap and influenza vaccine may be co-administered without compromise of either the reactogenicity or immunogenicity profiles of the two vaccines.