Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Nov;7(11):1130-6.
doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.

Safety and tolerability of zoster vaccine in adults ≥60 years old

Alexander V Murray  1 , Keith S Reisinger, Boris Kerzner, Jon E Stek, Timothy A Sausser, Jin Xu, William W Wang, Ivan S F Chan, Paula W Annunziato, Janie Parrino
Affiliations
Randomized Controlled Trial

Safety and tolerability of zoster vaccine in adults ≥60 years old

Alexander V Murray et al. Hum Vaccin. 2011 Nov.

Abstract

Objective: To evaluate the general safety of zoster vaccine (ZV) in adults ≥60 years old.

Patients/methods: Subjects were enrolled in a 1:1 ratio to receive 1 dose of ZV or placebo. Subjects were followed for serious adverse experiences (SAEs) for 42 days (primary follow-up period) and 182 days (secondary follow-up period) postvaccination. Relative-risks (ZV/placebo) for SAEs during both safety periods were calculated.

Study period: 17-Sep‑2007 to 09-Jan-2009.

Results: Overall, 5,983 subjects received ZV and 5,997 received placebo. Within the primary 42-day follow-up period, 84 ZV subjects and 67 placebo subjects reported SAEs. The estimated risk of SAEs within 42 days was 1.41% for ZV versus 1.12% for placebo, with a relative-risk of 1.26 (95% CI 0.91,1.73); indicating no statistically significant difference between groups, meeting the pre-specified success criterion. During the 182-day follow-up period, 340 ZV subjects and 300 placebo subjects reported SAEs. The estimated risk of SAEs within 182 days was 5.68% for ZV versus 5.01% for placebo, with a relative-risk of 1.13 (95% CI 0.98,1.32), indicating no statistically significant difference between groups. Two subjects in the ZV group reported SAEs deemed by the investigator to be vaccine-related (uveitis and sciatica; onset Day 5 and 4, respectively). One subject in the placebo group reported a SAE deemed by the investigator to be vaccine-related (lumbar radiculopathy; onset Day 51). There were 24 fatal SAEs in the ZV group and 17 in the placebo group (relative risk = 1.41; CI: 0.77, 2.60); 6 and 5, respectively, with SAE onset during the primary 42-day follow-up period. No deaths were deemed vaccine-related.

Conclusions: ZV and placebo groups had similar safety profiles in terms of SAEs during the primary (Day 1 to 42) and secondary (Day 1 to 182) follow-up periods.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Subject Accounting
See this image and copyright information in PMC

References

    1. Creed R, Satyaprakash A, Tyring SK. Varicella Zoster Virus. In: Tyring SK, Yen Moore A and Lupi O (eds). Mucocutaneous Manifestations of Viral Diseases, 2ed, London: Informa Healthcare; 2010:98-122.
    1. Johnson RW, Bouhassira D, Kassianos G, Leplège A, Schmader KE, Weinke T. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med. 2010;8:37. doi: 10.1186/1741-7015-8-37. - DOI - PMC - PubMed
    1. Zostavax (zoster vaccine, live) [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2009. Available at: http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_pi2.pdf Accessed 31-May-2011.
    1. Centers for Disease Control and Prevention Prevention of herpes zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Morb Mortal Wkly Rep. 2008;57:1–5. - PubMed
    1. National Health & Medical Research Council. The Australian immunisation handbook. Williams A, ed. Canberra: Australian Government Publishing Service, 2008.

Publication types

Substances