Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
NCT ID: NCT01040078
Last Updated: 2009-12-30
Study Results
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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UNKNOWN
PHASE3
900 participants
INTERVENTIONAL
2009-12-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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7.5ug H1N1 vaccine
360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.
7.5ug H1N1 Influenza vaccine
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
15ug H1N1 vaccine
360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.
15ug H1N1 vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
seasonal influenza vaccine
180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.
seasonal influenza vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Interventions
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7.5ug H1N1 Influenza vaccine
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
15ug H1N1 vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
seasonal influenza vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
35 Months
ALL
Yes
Sponsors
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Centers for Disease Control and Prevention, China
OTHER_GOV
Locations
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Lingchuan County CDC
Guilin, Guangxi, China
Luxi County CDC
Xiangxi Prefecture, Hunan, China
Yandu District CDC
Yancheng, Jiangsu, China
Countries
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Facility Contacts
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Yanping Li, Doctor
Role: primary
Fangjun Li, Doctor
Role: primary
Yuemei Hu, Doctor
Role: primary
Other Identifiers
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20090601
Identifier Type: -
Identifier Source: org_study_id