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The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

split-virion, non-adjuvanted H1N1 vaccine of 45 μg

Placebo control

About this trial

This is an interventional prevention trial for Influenza focused on measuring H1N1, Vaccine, Immunogenicity, Safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
Requests of clinical research program can be obeyed
No other protective product is inoculated in last week
Axillary temperature below 37 degrees Celsius

Exclusion Criteria:

Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
History of progressive or severe neurologic disorder
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
History of thyroidectomy or thyroid disease that required medication within the past 12 months
Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
Guillain-Barre Syndrome
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
Any conditions may influence the evaluation

Sites / Locations

Hunan Provincial Center of Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

split-virion, non-adjuvanted vaccine of 15 μg

split-virion, non-adjuvanted vaccine of 30 μg

split-virion, non-adjuvanted vaccine of 45 μg

Placebo control

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 15 μg.

split-virion, non-adjuvanted H1N1 vaccine of 30 μg.

split-virion, non-adjuvanted H1N1 vaccine of 45 μg.

Placebo control

Outcomes

Primary Outcome Measures

Hemagglutination inhibition antibody titer

Secondary Outcome Measures

occurrence of solicited local and systemic adverse events after vaccination

Full Information

NCT ID

NCT01336166

First Posted

April 7, 2011

Last Updated

September 8, 2018

Sponsor

Shanghai Institute Of Biological Products

1. Study Identification

Unique Protocol Identification Number

NCT01336166

Brief Title

The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Institute Of Biological Products

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

H1N1, Vaccine, Immunogenicity, Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Actual)

8. Arms, Groups, and Interventions

Arm Title

split-virion, non-adjuvanted vaccine of 15 μg

Arm Type

Experimental

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 15 μg.

Arm Title

split-virion, non-adjuvanted vaccine of 30 μg

Arm Type

Experimental

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 30 μg.

Arm Title

split-virion, non-adjuvanted vaccine of 45 μg

Arm Type

Experimental

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 45 μg.

Arm Title

Placebo control

Arm Type

Placebo Comparator

Arm Description

Placebo control

Intervention Type

Biological

Intervention Name(s)

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

Intervention Description

120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

Intervention Type

Biological

Intervention Name(s)

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

Intervention Description

120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.

Intervention Type

Biological

Intervention Name(s)

split-virion, non-adjuvanted H1N1 vaccine of 45 μg

Intervention Description

120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.

Intervention Type

Biological

Intervention Name(s)

Placebo control

Intervention Description

120 adults were assigned to receive 1 dose of placebo.

Primary Outcome Measure Information:

Title

Hemagglutination inhibition antibody titer

Time Frame

Day 180

Secondary Outcome Measure Information:

Title

occurrence of solicited local and systemic adverse events after vaccination

Time Frame

Days 0-42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy Requests of clinical research program can be obeyed No other protective product is inoculated in last week Axillary temperature below 37 degrees Celsius Exclusion Criteria: Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg History of progressive or severe neurologic disorder Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws History of thyroidectomy or thyroid disease that required medication within the past 12 months Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years Guillain-Barre Syndrome Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination Any conditions may influence the evaluation

Facility Information:

Facility Name

Hunan Provincial Center of Disease Prevention and Control

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410005

Country

China

12. IPD Sharing Statement

Learn more about this trial

The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

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