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

NCT00952419 | Completed Phase 2 Results

• 2 other identifiers: FUF15UTN: U1111-1111-4713
• Study Type: interventional
• Target: 474
• Locations: 1 country
• Sites: 20

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.

Conditions

Influenza; Swine-origin A/H1N1 Influenza

Keywords

Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Children

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

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

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

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

  Pre-vaccination (Day 0) and Day 21 post-vaccination

• Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

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

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

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

  Pre-vaccination (Day 0) and 21 days post-vaccination

• Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

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

  Pre-vaccination (Day 0) and Day 21 post-vaccination

• Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

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

  Pre-vaccination (Day 0) and Day 21 post-vaccination

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months

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

  Days 0 to 7 post-vaccination

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months

  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.

  Days 0 to 7 post-vaccination

• Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years

  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.

  Days 0 to 7 post vaccination

Study Arms (3)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 1

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

A/H1N1 Vaccine Group 2

EXPERIMENTAL

Participants will receive A/H1N1 vaccine formulation 2

Biological: Monovalent Subvirion A/H1N1 Influenza vaccine

Placebo Group

PLACEBO COMPARATOR

Participants will receive a placebo vaccine

Biological: Normal saline solution (placebo)

Interventions

Monovalent Subvirion A/H1N1 Influenza vaccine BIOLOGICAL

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)

A/H1N1 Vaccine Group 1

Normal saline solution (placebo) BIOLOGICAL

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 Group

Eligibility Criteria

• Age: 6 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Subjects aged 6 to 35 months:
• Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (20)

Unknown Facility

Miami Beach, Florida, 33141, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Crestview Hills, Kentucky, 41017, United States

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Louisville, Kentucky, 40291, United States

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Maddisonville, Kentucky, 42431, United States

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Metairie, Louisiana, 70006, United States

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Las Vegas, Nevada, 89104, United States

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Rochester, New York, 14609, United States

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Hermitage, Pennsylvania, 16148, United States

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Pittsburgh, Pennsylvania, 15237, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Cranston, Rhode Island, O2920, United States

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Barnwell, South Carolina, 29812, United States

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Austin, Texas, 78705, United States

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Fort Worth, Texas, 76135, United States

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San Angelo, Texas, 76904, United States

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Orem, Utah, 84057, United States

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South Jordan, Utah, 84095, United States

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Springville, Utah, 84663, United States

Location

Related Publications (2)

• Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche 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. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.

  PMID: 21219979 RESULT

• Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche 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. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.

  PMID: 20018365 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 14, 2016
• Results First Posted: July 11, 2011

Record last verified: 2016-04

Locations

US (20)