Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV).

Primary objective:

• To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

Secondary objective:

• To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

Detailed Description

Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).

• Study Type: Interventional
• Enrollment (Actual): 602
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged ≥ 6 months on the day of inclusion

• Informed Consent Form has been signed and dated:

  • by the parent(s) or legally acceptable representative, if applicable, for subjects <18 years of age. Additionally, an assent form has been signed by the subject if aged 10 to 17 years (based on local regulations).
  • by the subject himself/herself for subjects ≥18 years of age.
• Subject and parent(s)/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
• For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
• For subjects aged 3-8 years only: Subject has previously received at least one dose of influenza vaccine in the past years or has a history of prior exposure to influenza virus through natural infection.

Exclusion Criteria:

• Subject is pregnant (positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or 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 first 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 or planned receipt of any vaccine within the period from 2 weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the period from 2 weeks before the first trial vaccination to 2 weeks after the second trial vaccination (subjects aged 6-35 months)
• For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2 consecutive doses of influenza vaccine [same seasonal strain composition]) any time prior to study enrollment or history of prior exposure to influenza virus through natural infection
• Vaccination against influenza given in the past 6 months with any influenza vaccine or planned receipt of influenza vaccination during the present study
• Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• 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)
• Reported history of seropositivity for Human Immunodeficiency Virus (HIV), after questioning the subject or the subject's parents or another legally acceptable representative
• 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 substance
• Self-reported thrombocytopenia, as reported by the subject, parent or legally acceptable representative contraindicating intramuscular vaccination
• 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 that might interfere with the ability to comply with trial procedures
• 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 (axillary temperature ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects aged 6 to 35 months (Group 1); Participants aged 6 months to 35 months will receive two 0.25 mL doses of SP Shz TIV given 28 days apart.	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.25 mL Intramuscular (2 doses given 28 days apart); Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.5 mL Intramuscular
Experimental: Subjects aged 3 to 17 years (Group 2); Participants aged 3 years to 17 years will receive a single 0.5 mL dose of SP Shz TIV	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.25 mL Intramuscular (2 doses given 28 days apart); Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.5 mL Intramuscular
Experimental: Subjects aged 18 to 60 years (Group 3); Participants aged 18 years to 60 years will receive a single 0.5 mL dose of SP Shz TIV	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.25 mL Intramuscular (2 doses given 28 days apart); Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.5 mL Intramuscular
Experimental: Subjects aged 61 years or older (Group 4); Participants aged 61 years or older will receive a single 0.5 mL dose of SP Shz TIV	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.25 mL Intramuscular (2 doses given 28 days apart); Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation; 0.5 mL Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine	Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.	Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine	Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.	Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine	Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.	Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine	Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years). Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)	Day 0 up to Day 7 post any vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 26, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Influenza; Trivalent influenza vaccine; Sanofi Pasteur Shenzhen trivalent influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: FST01; U1111-1143-8684 (Other Identifier: WHO); CTR20140452 (Registry Identifier: Chinese Clinical Trial Registry)