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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00952419
First received: August 3, 2009
Last updated: January 9, 2014
Last verified: January 2014

August 3, 2009
January 9, 2014
August 2009
March 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ] [ Designated as safety issue: No ]
    Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ] [ Designated as safety issue: No ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
  • Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months [ Time Frame: Days 0 to 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
  • Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months [ Time Frame: Days 0 to 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
  • Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years [ Time Frame: Days 0 to 7 post vaccination ] [ Designated as safety issue: No ]
    Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
  • Safety: To provide information concerning the safety after primary administration of influenza A/H1N1 vaccine. [ Time Frame: 0-7 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
  • Immunogenicity: To provide information concerning the immunogenicity of influenza A/H1N1 vaccine after primary vaccination. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952419 on ClinicalTrials.gov Archive Site
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A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Influenza
  • Swine-origin A/H1N1 Influenza
  • Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
  • Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
  • Biological: Normal saline solution (placebo)
    0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
  • Experimental: A/H1N1 Vaccine Group 1
    Participants will receive A/H1N1 vaccine formulation 1
    Intervention: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
  • Experimental: A/H1N1 Vaccine Group 2
    Participants will receive A/H1N1 vaccine formulation 2
    Intervention: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
  • Placebo Comparator: Placebo Group
    Participants will receive a placebo vaccine
    Intervention: Biological: Normal saline solution (placebo)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
474
June 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
6 Months to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952419
FUF15, UTN: U1111-1111-4713
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP