A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Sanofi

Status and phase: Completed; Phase 2

Conditions: Influenza; Swine-origin A/H1N1 Influenza

Treatments: Biological: Normal saline solution (placebo); Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00952419

UTN: U1111-1111-4713

FUF15

Details and patient eligibility

About

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

• To describe the immunogenicity of the candidate vaccines after each injection.
• To describe the safety of the candidate vaccines after each injection.

Full description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Enrollment: 474 patients

Sex: All

Ages: 6 months to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

All subjects:

• Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
• Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures

Subjects aged 3 to 9 years:

• Healthy children aged 3 to 9 years on the day of inclusion

Subjects aged 6 to 35 months:

• Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

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 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)
• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
• 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
• Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
• Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
• Personal or family history of Guillain-Barré syndrome
• Active neoplastic disease or a history of any hematologic malignancy
• Known seizure/epilepsy history and/or taking anti-seizure medication
• Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
• Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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474 participants in 3 patient groups, including a placebo group

A/H1N1 Vaccine Group 1

Experimental group

Description:

Participants will receive A/H1N1 vaccine formulation 1

Treatment:

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

A/H1N1 Vaccine Group 2

Experimental group

Description:

Participants will receive A/H1N1 vaccine formulation 2

Treatment:

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

Placebo Group

Placebo Comparator group

Description:

Participants will receive a placebo vaccine

Treatment:

Biological: Normal saline solution (placebo)