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Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

NCT01069367 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-12-01

No results posted yet for this study

Summary

This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety \& tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.

Conditions

  • Swine-Origin Influenza A H1N1 Virus

Interventions

BIOLOGICAL

Emulsion, Cell Culture-based, influenza HA vaccine H1N1

Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Japan

Study Locations

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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 NCT01069367 on ClinicalTrials.gov