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

NCT02228980 | Completed Phase 4 Results

• 3 other identifiers: FST01U1111-1143-8684CTR20140452
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Influenza

Keywords

Influenza; Trivalent influenza vaccine; Sanofi Pasteur Shenzhen trivalent influenza vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine

  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

  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

  Day 0 up to Day 7 post any vaccination

Study Arms (4)

Subjects aged 6 to 35 months (Group 1)

EXPERIMENTAL

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

Subjects aged 3 to 17 years (Group 2)

EXPERIMENTAL

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

Subjects aged 18 to 60 years (Group 3)

EXPERIMENTAL

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

Subjects aged 61 years or older (Group 4)

EXPERIMENTAL

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

Interventions

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation BIOLOGICAL

0.25 mL Intramuscular (2 doses given 28 days apart)

Subjects aged 6 to 35 months (Group 1)

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Nanning, Guangxi, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: August 29, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: October 1, 2015
• Last Updated: January 29, 2016
• Results First Posted: January 29, 2016

Record last verified: 2015-12

Locations

CN (1)