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

Phase 3

• Conditions: Influenza; Swine-origin A/H1N1 Influenza
• Interventions: Biological: 7.5ug H1N1 Influenza vaccine; Biological: 15ug H1N1 vaccine; Biological: seasonal influenza vaccine

• Registration Number: NCT01040078
• Lead Sponsor: Centers for Disease Control and Prevention, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted: 2009-12-24
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Last Update Submitted: 2009-12-29
• Last Update Posted: 2009-12-30
• Primary Completion: 2010-02
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
7.5ug H1N1 vaccine	7.5ug H1N1 Influenza vaccine	360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.
15ug H1N1 vaccine	15ug H1N1 vaccine	360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.
seasonal influenza vaccine	seasonal influenza vaccine	180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.

Trial Locations

Locations (3)

Lingchuan County CDC; 🇨🇳 Guilin, Guangxi, China

Luxi County CDC; 🇨🇳 Xiangxi Prefecture, Hunan, China

Yandu District CDC; 🇨🇳 Yancheng, Jiangsu, China