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

Influenza Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01040078
• Other study ID #: 20090601
• Status: Recruiting
• Phase: Phase 3
• First received: December 24, 2009
• Last updated: December 29, 2009
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: December 2009
• Source: Centers for Disease Control and Prevention, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Swine-origin A/H1N1 Influenza

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Lingchuan County CDC	Guilin	Guangxi
China	Luxi County CDC	Xiangxi Prefecture	Hunan
China	Yandu District CDC	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China,