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Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Primary Purpose

Influenza

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

split-virion, non-adjuvanted vaccine of 7.5 μg

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

split-virion, non-adjuvanted vaccine of seasonal influenza

About this trial

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

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy infants aged between 6 and 35 months
full-term birth with birth weight above 2,500 grams
Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures

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 Changsha, Hunan, China

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

split-virion, non-adjuvanted vaccine of 7.5 μg

split-virion, non-adjuvanted vaccine of 15 μg

split-virion, non-adjuvanted vaccine of seasonal influenza

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.

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

split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.

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

NCT01494740

First Posted

December 15, 2011

Last Updated

December 16, 2011

Sponsor

Shanghai Institute Of Biological Products

1. Study Identification

Unique Protocol Identification Number

NCT01494740

Brief Title

Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Official Title

Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (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 immunogenicity and safety of the inactivated split-virion vaccine in infants.

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, infants

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

split-virion, non-adjuvanted vaccine of 7.5 μg

Arm Type

Experimental

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.

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 seasonal influenza

Arm Type

Placebo Comparator

Arm Description

split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.

Intervention Type

Biological

Intervention Name(s)

split-virion, non-adjuvanted vaccine of 7.5 μg

Intervention Description

120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

Intervention Type

Biological

Intervention Name(s)

split-virion, non-adjuvanted vaccine of seasonal influenza

Intervention Description

120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

Primary Outcome Measure Information:

Title

Hemagglutination inhibition antibody titer

Time Frame

Days 35

Secondary Outcome Measure Information:

Title

Occurrence of solicited local and systemic adverse events after vaccination

Time Frame

Day0-42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infants aged between 6 and 35 months full-term birth with birth weight above 2,500 grams Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures 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 Changsha, Hunan, China

City

Changsha

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

25110632

Citation

Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014.

Results Reference

derived

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Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

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