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Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

Primary Purpose

Influenza, Swine-origin A/H1N1 Influenza

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

7.5ug H1N1 Influenza vaccine

15ug H1N1 vaccine

seasonal influenza 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:

Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Planned receipt of any vaccine prior to the Day 42 blood sample
Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
Family members of the employees or the Investigator
Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
Confirmed infection with the novel influenza A/H1N1 strain
Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment

Sites / Locations

Lingchuan County CDCRecruiting
Luxi County CDCRecruiting
Yandu District CDCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

7.5ug H1N1 vaccine

15ug H1N1 vaccine

seasonal influenza vaccine

Arm Description

360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.

360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.

180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01040078

First Posted

December 24, 2009

Last Updated

December 29, 2009

Sponsor

Centers for Disease Control and Prevention, China

1. Study Identification

Unique Protocol Identification Number

NCT01040078

Brief Title

Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Centers for Disease Control and Prevention, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

6. Conditions and Keywords

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

Influenza, Swine-origin A/H1N1 Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

7.5ug H1N1 vaccine

Arm Type

Experimental

Arm Description

360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.

Arm Title

15ug H1N1 vaccine

Arm Type

Experimental

Arm Description

360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.

Arm Title

seasonal influenza vaccine

Arm Type

Placebo Comparator

Arm Description

180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.

Intervention Type

Biological

Intervention Name(s)

7.5ug H1N1 Influenza vaccine

Intervention Description

0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

Intervention Type

Biological

Intervention Name(s)

15ug H1N1 vaccine

Intervention Description

0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

Intervention Type

Biological

Intervention Name(s)

seasonal influenza vaccine

Intervention Description

0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

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: Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Receipt of any vaccine in the 4 weeks preceding the first trial vaccination Planned receipt of any vaccine prior to the Day 42 blood sample Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion Family members of the employees or the Investigator Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain Confirmed infection with the novel influenza A/H1N1 strain Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment

Facility Information:

Facility Name

Lingchuan County CDC

City

Guilin

State/Province

Guangxi

ZIP/Postal Code

541000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yanping Li, Doctor

Phone

0773 6812175

lyp898@163.com

Facility Name

Luxi County CDC

City

Xiangxi Prefecture

State/Province

Hunan

ZIP/Postal Code

416100

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fangjun Li, Doctor

Phone

0743 4265397

fangjunliself678@sina.com

Facility Name

Yandu District CDC

City

Yancheng

State/Province

Jiangsu

ZIP/Postal Code

224001

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuemei Hu, Doctor

Phone

0515 8324084

993832717@qq.com

12. IPD Sharing Statement

Learn more about this trial

Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

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