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:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00952419
First received: August 3, 2009
Last updated: July 8, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Influenza Swine-origin A/H1N1 Influenza |
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine Biological: Normal saline solution (placebo) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
| Enrollment: | 474 |
| Study Start Date: | August 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Detailed Description:
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Eligibility| Ages Eligible for Study: | 6 Months to 9 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952419
Locations
| 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, 15241 | |
| Pittsburgh, Pennsylvania, United States, 15237 | |
| 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
Investigators
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00952419 History of Changes |
| Other Study ID Numbers: | FUF15, UTN: U1111-1111-4713 |
| Study First Received: | August 3, 2009 |
| Results First Received: | June 8, 2011 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Children |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013