Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-11-30

Brief Summary

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A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

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Detailed Description

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1. Assessment of Safety
2. Assessment of Immunogenicity
3. Estimated Enrollment: 100

Conditions

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Prevention of Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

NBP607 0.5ml

Group Type EXPERIMENTAL

NBP607

Intervention Type BIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

Group 2

Agrippal 0.5ml

Group Type ACTIVE_COMPARATOR

Agrippal

Intervention Type BIOLOGICAL

1 dose, 0.5ml, Intramuscular (IM) injection

Interventions

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NBP607

1 dose, 0.5ml, Intramuscular (IM) injection

Intervention Type BIOLOGICAL

Agrippal

1 dose, 0.5ml, Intramuscular (IM) injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. 20 to \<60 years of age
2. able and willing to give written informed consent prior to study entry
3. if female, at least 2 years after post- menopausal and negative result of urine-human chorionic gonadotropin (HCG) test at screening

Exclusion Criteria

1. hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
2. Immunodeficiency disease
3. history of hypersensitivity when vaccination, such as Guillain-Barre syndrome
4. thrombocytopenia or Coagulation disorders
5. experienced fever (\>37.5°C) within the past 24 hours or any acute respiratory infection
6. receipt of Immunosuppressants or Immunomodulators within the past 3 months
7. receipt of blood products or immunoglobulin within the past 3 months
8. received influenza vaccine within the past 6 months
9. received another vaccine within the past 1 month or plans vaccination within 1 months following the study vaccination
10. participation on another clinical trial within 1 month prior to the study vaccination
11. history of blood donation within 1 week prior to the study vaccination for plan of blood donation within 7 days following the study vaccination
12. any chronic diseases that interfere with the clinical trial or Malignant tumors
13. pregnant or breastfeeding
14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.

Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes