ong-term survival and causes of death after influenza vaccination in the elderly.

Completed

Conditions: overall mortalityinfluenza-related mortality (influenza, pneumonia, respiratory and circulatory causes of death)

Registration Number: NL-OMON22975

Lead Sponsor: one

Brief Summary: Govaert TM, Thijs CT, Masurel N, Sprenger MJ, Dinant GJ, Knottnerus JA. The efficacy of influenza vaccination in elderly individuals. A randomized double-blind placebo-controlled trial. JAMA. 1994 Dec 7;272(21):1661-5. Cruijff M, Thijs C, Govaert T, Aretz K, Dinant GJ, Knottnerus A. The effect of smoking on influenza, influenza vaccination efficacy and on the antibody response to influenza vaccination. Vaccine. 1999 Feb 5;17(5):426-32 Govaert TM, Sprenger MJ, Dinant GJ, Aretz K, Masurel N, Knottnerus JA. Immune response to influenza vaccination of elderly people. A randomized double-blind placebo-controlled trial. Vaccine. 1994 Oct;12(13):1185-9. Govaert TM, Dinant GJ, Aretz K, Masurel N, Sprenger MJ, Knottnerus JA. Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial. BMJ. 1993 Oct 16;307(6910):988-90.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1838

Inclusion Criteria

A randomized clinical trial on the efficacy of influenza vaccination in the elderly, involving 31 general practitioners in 15 practices in the southern region of the Netherlands, was conducted in the winter of 1991-1992. All persons aged 60 years or older were invited to enter the trial if they did not belong to those high-risk groups in which vaccination was recommended. At that time, age was no criterion for recommendation. In total 1838 patients (869 male, 989 female) agreed to participate. Of those who enrolled, 490 patients with heart conditions, lung conditions or diabetes mellitus were not considered to belong to the high-risk group by their general practitioner. In order to perform the new study, we complement the data of the previous trial with present information on mortality of the former participants. In specific, date and causes of death are added.

Exclusion Criteria

All former trial participants (n=1838) were included. In case of loss to follow-up, the data was censored. No participants were excluded from the analysis.