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Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pandemic influenza A/H1N1 vaccine

Seasonal trivalent vaccine

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male or female aged between 6 and 35 months
Full-term birth, birth weight 2,500 grams or more
provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

Cases, cured cases and close contact of influenza A (H1N1) virus
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Symptoms of acute infection within a week
Autoimmune disease or immunodeficiency
Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
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 or family history of convulsions, epilepsy, brain disease and psychiatric
Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
Guillain-Barre Syndrome
Administration of 2009-2010 seasonal vaccine
History of any blood products within 3 months
Administration of any other investigational research agents within 30 days
Administration of any live attenuated vaccine within 30 days
Administration of subunit or inactivated vaccines within 14 days
Be receiving anti-TB prophylaxis or therapy currently
Axillary temperature > 37.0 centigrade at the time of dosing
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Sites / Locations

GuangXi Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine

Group 2 : 15 μg pandemic influenza A/H1N1 vaccine

Group 3 : 7.5 μg seasonal trivalent vaccine

Arm Description

120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart

120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart

60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart

Outcomes

Primary Outcome Measures

Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants

Secondary Outcome Measures

Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants

Full Information

NCT ID

NCT01047202

First Posted

January 11, 2010

Last Updated

March 13, 2013

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01047202

Brief Title

Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

Official Title

A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Biotech Co., Ltd

4. Oversight

5. Study Description

Brief Summary

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

6. Conditions and Keywords

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

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine

Arm Type

Experimental

Arm Description

120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart

Arm Title

Group 2 : 15 μg pandemic influenza A/H1N1 vaccine

Arm Type

Experimental

Arm Description

120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart

Arm Title

Group 3 : 7.5 μg seasonal trivalent vaccine

Arm Type

Sham Comparator

Arm Description

60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart

Intervention Type

Biological

Intervention Name(s)

Pandemic influenza A/H1N1 vaccine

Intervention Description

Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

Intervention Type

Biological

Intervention Name(s)

Pandemic influenza A/H1N1 vaccine

Intervention Description

Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

Intervention Type

Biological

Intervention Name(s)

Seasonal trivalent vaccine

Intervention Description

Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

Primary Outcome Measure Information:

Title

Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or female aged between 6 and 35 months Full-term birth, birth weight 2,500 grams or more provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent Exclusion Criteria: Cases, cured cases and close contact of influenza A (H1N1) virus Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Symptoms of acute infection within a week Autoimmune disease or immunodeficiency Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) 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 or family history of convulsions, epilepsy, brain disease and psychiatric Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen Guillain-Barre Syndrome Administration of 2009-2010 seasonal vaccine History of any blood products within 3 months Administration of any other investigational research agents within 30 days Administration of any live attenuated vaccine within 30 days Administration of subunit or inactivated vaccines within 14 days Be receiving anti-TB prophylaxis or therapy currently Axillary temperature > 37.0 centigrade at the time of dosing Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Facility Information:

Facility Name

GuangXi Center for Diseases Control and Prevention

City

Guilin

State/Province

Guangxi

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23134570

Citation

Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.

Results Reference

derived

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Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

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