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Completed

NCT Number: NCT00952419

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children 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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Swine-origin A/H1N1 Influenza Virus Diseases

Age range

6 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami Beach, Florida, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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