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Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

NCT01161264 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-03-10

No results posted yet for this study

Summary

Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).

Conditions

Interventions

BIOLOGICAL

Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011

Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1.

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Germany

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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 NCT01161264 on ClinicalTrials.gov