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

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ClinicalTrials.gov Identifier: NCT00952419
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : July 11, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Influenza Swine-origin A/H1N1 Influenza Biological: Monovalent Subvirion A/H1N1 Influenza vaccine Biological: Normal saline solution (placebo) Phase 2

Detailed Description:
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
 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)
Experimental: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
 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)
Placebo Comparator: Placebo Group
Participants will receive a placebo vaccine
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  2. 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 ]
    Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  3. 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 ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  4. 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 ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  5. 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 ]
    Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.

  6. 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 ]
    Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.

  7. 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 ]
    Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.

  8. 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 ]
    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.

  9. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952419


Locations
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United States, Florida
Miami Beach, Florida, United States, 33141
United States, Georgia
Marietta, Georgia, United States, 30062
Woodstock, Georgia, United States, 30189
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
Louisville, Kentucky, United States, 40291
Maddisonville, Kentucky, United States, 42431
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Nevada
Las Vegas, Nevada, United States, 89104
United States, New York
Rochester, New York, United States, 14609
United States, Pennsylvania
Hermitage, Pennsylvania, United States, 16148
Pittsburgh, Pennsylvania, United States, 15237
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
Cranston, Rhode Island, United States, O2920
United States, South Carolina
Barnwell, South Carolina, United States, 29812
United States, Texas
Austin, Texas, United States, 78705
Fort Worth, Texas, United States, 76135
San Angelo, Texas, United States, 76904
United States, Utah
Orem, Utah, United States, 84057
South Jordan, Utah, United States, 84095
Springville, Utah, United States, 84663
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Monitor Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00952419    
Other Study ID Numbers: FUF15
UTN: U1111-1111-4713
First Posted: August 6, 2009    Key Record Dates
Results First Posted: July 11, 2011
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Pandemic Flu
Swine-origin A/H1N1 Influenza
Children
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs