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Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

NCT00848848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-05-09

No results posted yet for this study

Summary

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Conditions

Interventions

BIOLOGICAL

Trivalent Influenza Vaccine

1 dose of Trivalent Influenza Vaccine

BIOLOGICAL

Trivalent Influenza Vaccine + high A

1 dose of Trivalent Influenza Vaccine with high A content

BIOLOGICAL

Trivalent Influenza Vaccine + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ¼ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + ¼ dose adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus ¼ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine plus ½ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + ½ dose adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus ½ dose adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + adjuvant

1 dose of Trivalent Influenza Vaccine plus adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine + high A + adjuvant

1 dose of Trivalent Influenza Vaccine with high A plus adjuvant

BIOLOGICAL

Trivalent Influenza Vaccine intradermal dose

1 dose of Trivalent Influenza Vaccine intradermal dose

BIOLOGICAL

Trivalent Influenza Vaccine + high A intradermal dose

1 intradermal dose of Trivalent Influenza Vaccine + high A

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT00848848 on ClinicalTrials.gov