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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00952419

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-Aventis:

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-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoché MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. Epub 2011 Jan 8.

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

Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. Epub 2009 Dec 15.

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-Aventis:

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 23, 2012