Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

• Registration Number: NCT01967784
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan

Primary Objective:

* To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation

Secondary Objective:

* To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation

Detailed Description

Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Primary Completion: 2014-04
• Study Completion: 2014-07
• Status Verified: 2015-12
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Results First Posted: 2016-01-20
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged 9 to 17 years on the day of inclusion
• Assent form (AF) and/or informed consent form (ICF) have been signed and dated by the subject according to each site requirements, and ICF has been signed and dated by the parent(s) or another legally acceptable representative(s) and by an independent witness if applicable
• Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria

• Subject is pregnant (or positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
• Participation at the time of study enrollment or in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
• Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or in the previous 6 months if administered in the context of a flu vaccination campaign
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• 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)
• Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning
• Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
• Known or suspected thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination upon investigator's judgment
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Identified as a family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Quadrivalent Influenza Vaccine (split virion, inactivated)	Participants age 9 to 17 years will receive a dose of Quadrivalent Influenza Vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine	Day 0 (pre-vaccination) and Day 21 post-vaccination	Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine	Day 0 (pre-vaccination) and Day 21 post-vaccination	Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine	Day 0 (pre-vaccination) and Day 21 post-vaccination	Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine	Day 21 post-vaccination	Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer \<10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine	Day 0 up to Day 7 post-vaccination	Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, \> 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.