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

NCT01040078 | Unknown Phase 3 DMC

• 1 other identifier: 20090601
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

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.

Conditions

Influenza; Swine-origin A/H1N1 Influenza

Study Arms (3)

7.5ug H1N1 vaccine

EXPERIMENTAL

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

Biological: 7.5ug H1N1 Influenza vaccine

15ug H1N1 vaccine

EXPERIMENTAL

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

Biological: 15ug H1N1 vaccine

seasonal influenza vaccine

PLACEBO COMPARATOR

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

Biological: seasonal influenza vaccine

Interventions

7.5ug H1N1 Influenza vaccine BIOLOGICAL

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

7.5ug H1N1 vaccine

15ug H1N1 vaccine BIOLOGICAL

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

15ug H1N1 vaccine

seasonal influenza vaccine BIOLOGICAL

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

seasonal influenza vaccine

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention, China: lead

Study Sites (3)

Lingchuan County CDC

Guilin, Guangxi, 541000, China

RECRUITING

Luxi County CDC

Xiangxi Prefecture, Hunan, 416100, China

RECRUITING

Yandu District CDC

Yancheng, Jiangsu, 224001, China

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 24, 2009
• First Posted: December 25, 2009
• Study Start: December 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 30, 2009

Record last verified: 2009-12

Locations

CN (3)