Influenza, Swine-origin A/H1N1 Influenza
Conditions
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.
Interventions
BIOLOGICAL7.5ug H1N1 Influenza vaccine
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
BIOLOGICAL15ug H1N1 vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
BIOLOGICALseasonal influenza vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Sponsors
Centers for Disease Control and Prevention, China
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
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
Countries
China
Outcome results
None listed