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Prospective Cohort Study to Evaluate Safety/Immunogenicity of Butantan Influenza Vaccine in Healthy Adults/Elderly

NCT02313740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2015-07-21

No results posted yet for this study

Summary

Prospective cohort study to evaluate safety and immunogenicity of the fragmented, inactivated trivalent Influenza vaccine produced at Butantan Institute in healthy adults and elderly. The study will include a total of 120 participants: 60 participants aged 18 to 59 years in the healthy adults group, and 60 participants aged older than 60 years in the elderly group.This study will evaluate the safety of one dose of the fragmented, inactivated trivalent Influenza vaccine in the first 3 days after vaccination, as well as its immunogenicity 21 days after vaccination.

Conditions

Interventions

BIOLOGICAL

Butantan Fragmented Inactivated Trivalent Influenza Vaccine

Subjects participating in the study are exposed to Butantan´s Fragmented Inactivated Trivalent Influenza Vaccine during vaccination campaign, and will have immunogenicity and safety related to the vaccine evaluated (observational study).

Sponsors & Collaborators

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Alex R Precioso, MD, PhD · Butantan Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-30
Completion
2015-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313740 on ClinicalTrials.gov