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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952419
• Other study ID #: FUF15
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2009
• Last updated: April 12, 2016
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 9 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Swine-origin A/H1N1 Influenza

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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