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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.
Vaccine. 2012 02 21; 30(9):1721-8.V

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

GSK Biologicals, GlaxoSmithKline, King of Prussia, PA 19406, USA. Wayde.Weston@gsk.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22212127

Citation

Weston, Wayde M., et al. "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." Vaccine, vol. 30, no. 9, 2012, pp. 1721-8.
Weston WM, Friedland LR, Wu X, et al. 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. Vaccine. 2012;30(9):1721-8.
Weston, W. M., Friedland, L. R., Wu, X., & Howe, B. (2012). 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. Vaccine, 30(9), 1721-8. https://doi.org/10.1016/j.vaccine.2011.12.055
Weston WM, et al. 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. Vaccine. 2012 02 21;30(9):1721-8. PubMed PMID: 22212127.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Weston,Wayde M, AU - Friedland,Leonard R, AU - Wu,Xiangfeng, AU - Howe,Barbara, Y1 - 2011/12/31/ PY - 2011/05/27/received PY - 2011/12/08/revised PY - 2011/12/11/accepted PY - 2012/1/4/entrez PY - 2012/1/4/pubmed PY - 2012/6/23/medline SP - 1721 EP - 8 JF - Vaccine JO - Vaccine VL - 30 IS - 9 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22212127/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01990-6 DB - PRIME DP - Unbound Medicine ER -