Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02539108
• Other study ID #: GRC58
• Secondary ID: U1111-1161-2526
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 31, 2015
• Last updated: December 7, 2015
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the safety and immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

Objective:

• To describe the safety of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in children 6 months to < 9 years of age.

Observational objectives:

• To describe the immunogenicity of the 2015-2016 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.

• To submit available sera from each subject to CBER for further analysis by the WHO, the CDC, and the FDA to support formulation recommendations for subsequent influenza vaccines.

Description:

Study participants will be assigned to the appropriate age group (6 months to < 36 months of age or 3 years to < 9 years of age) based on the subject's age at the time of enrollment. Participants aged 6 months to < 36 months will receive a 0.25 mL dose of Fluzone Quadrivalent vaccine and those aged 3 years to < 9 years will receive a 0.5 mL dose of Fluzone Quadrivalent vaccine. Participants, for whom 2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose of Fluzone Quadrivalent vaccine during Visit 2 (28 days after Visit 1).

Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2 or to Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will be collected from Visit 1 to Visit 2 or Visit 3, as appropriate.

Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs) will be calculated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 8 Years

Eligibility

Inclusion Criteria:

• Subject is 6 months to < 9 years of age on the day of first study vaccination (study product administration)

• Subject and parent/guardian are willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study

• Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or guardian for subjects 6 months to < 9 years of age

• For subjects 6 months to < 12 months of age, born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (5.5 lbs).

Exclusion Criteria:

• Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)

• History of serious adverse reaction to any influenza vaccine

• Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine

• Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study

• Prior vaccination with any formulation of 2015-2016 influenza vaccine

• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator

• Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator

• Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine

• Personal history of Guillain-Barré syndrome

• Known or suspected congenital or acquired immunodeficiency; or receipt of 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)

• Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder

• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion

• Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

• Receipt of immune globulins, blood, or blood-derived products in the past 3 months

• Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluzone® Quadrivalent Influenza Vaccine, No Preservative
0.25 mL, Intramuscular (Pediatric Dose, 2015 2016 formulation)
• Fluzone® Quadrivalent Influenza Vaccine, No Preservative
0.5 mL, Intramuscular (2015 2016 formulation)

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting solicited injection site and systemic events and unsolicited adverse events following vaccination with Fluzone Quadrivalent vaccine.	Participants 6 Months to < 36 Months of Age: Solicited injection site reactions: Tenderness, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Participants 3 Years to < 9 Years of Age: Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Unsolicited adverse events, including serious adverse events will also be collected for all participants.	up to Day 28 post vaccination	No
Secondary	Geometric mean titers of antibodies to vaccine antigens following final vaccination with Fluzone Quadrivalent vaccine	Immunogenicity will be evaluated prior to vaccination and at 28 days after final vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) will be calculated	Day 0 and Day 28 after final vaccination	No
Secondary	Seroprotection with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent vaccine	Seroprotection is defined as: a titer = 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.	Day 0 and Day 28 after final vaccination	No
Secondary	Seroconversion with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent vaccine	Seroconversion is defined as either a pre vaccination titer < 10 (1/dil), and a post vaccination titer = 40 (1/dil), or a pre vaccination titer = 10 (1/dil) and a = 4 fold increase in post vaccination titer at Day 28 after the final vaccination.	Day 28 after final vaccination	No

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