Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine

ID: NCT03391193
Status: Active, not recruiting
Phase: Phase 3
Start Date: December 19, 2017
First Submitted: December 21, 2017
Last Updated: February 08, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi Pasteur, a Sanofi Company
Location: Mexico
Conditions: Influenza
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Study Description

Brief Summary

The aim of the study is to to assess the immunogenicity and safety of a quadrivalent influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine in single-dose presentation, in children aged 6 months to 17 years.

Detailed Description

Participants aged 9 to 17 years will receive one dose of either the multi-dose quadrivalent influenza vaccine or the quadrivalent influenza vaccine in a single-dose presentation and participants aged 6 months to 8 years will receive 2 doses of either vaccine, 28 days apart.

All participants will provide a pre-vaccination blood sample on Day 0 and a post-vaccination blood sample either on Day 28 (participants aged 9 to 17 years) or on Day 56 (participants aged 6 months to 8 years) for immunogenicity testing.

All participants will be followed for safety evaluation up to 6 months after the last vaccination.
Condition or disease Intervention/treatment Phase

Influenza

Biological: Multi-dose Quadrivalent Influenza Vaccine
Other Names
Biological: Single-dose Quadrivalent Influenza Vaccine
Other Names
VaxigripTetra
Phase 3

Tracking Information

First Submitted DateDecember 21, 2017
Last Update Posted DateFebruary 08, 2018
Actual Start DateDecember 19, 2017
Anticipated Completion DateSeptember 04, 2018
Actual Primary Completion DateMarch 30, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Seroconversion Rates after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine [Time Frame: Day 28 (post-last vaccination)]

    Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. Seroconversion is defined as either post-vaccination titer ≥ 40 (1/dil), or pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase in post-vaccination titer

  • GMT Ratio after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine [Time Frame: Day 28 (post-last vaccination)]

    Anti-HA antibody titers against the 4 influenza strains are assessed by an HAI assay. GMT ratio is assessed as the individual ratio of post-/pre-vaccination titers

  • Geometric Mean Titers (GMTs) of Antibodies after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine [Time Frame: Day 28 (post-last vaccination)]

    Anti-hemagglutinin (HA) antibody titers against the 4 influenza strains are assessed by a hemagglutination inhibition (HAI) assay

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions after Vaccination with Multi-dose Quadrivalent Influenza Vaccine or Single-dose Quadrivalent Influenza Vaccine [Time Frame: Day 0 (pre-vaccination) to Day 7 (after any vaccination)]

    Solicited injection site reactions are tenderness/pain,erythema, swelling, induration, ecchymosis, and solicited systemic reactions are fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability (for children ≤ 23 months), and fever, headache, malaise, myalgia, and shivering (for children 2 to 17 years)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleImmunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine
Official TitleImmunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 Months to 17 Years
Brief Summary

The aim of the study is to to assess the immunogenicity and safety of a quadrivalent influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine in single-dose presentation, in children aged 6 months to 17 years.

Detailed Description

Participants aged 9 to 17 years will receive one dose of either the multi-dose quadrivalent influenza vaccine or the quadrivalent influenza vaccine in a single-dose presentation and participants aged 6 months to 8 years will receive 2 doses of either vaccine, 28 days apart.

All participants will provide a pre-vaccination blood sample on Day 0 and a post-vaccination blood sample either on Day 28 (participants aged 9 to 17 years) or on Day 56 (participants aged 6 months to 8 years) for immunogenicity testing.

All participants will be followed for safety evaluation up to 6 months after the last vaccination.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
301
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
Influenza
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: Multi-dose Quadrivalent Influenza Vaccine

0.5 mL, intramuscular

Other Names
Biological: Single-dose Quadrivalent Influenza Vaccine

0.5 mL, intramuscular

Other Names
VaxigripTetra
Study Groups/Cohorts
Multi-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart

Single-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart

Study Arms
Experimental Multi-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart
Biological : Multi-dose Quadrivalent Influenza Vaccine
0.5 mL, intramuscular

Active Comparator Single-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart
Biological : Single-dose Quadrivalent Influenza Vaccine
0.5 mL, intramuscular

Arm Intervention/Treatment
Experimental Multi-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal containing) in multi-dose presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart
Biological : Multi-dose Quadrivalent Influenza Vaccine
Active Comparator Single-dose Quadrivalent Influenza Vaccine
Quadrivalent influenza vaccine (split-virion, inactivated, 2017-2018 formulation, thiomersal free) in single-dose syringe presentation. Participants aged 9 to 17 years will receive 1 dose and subjects aged 6 months to 8 years will receive 2 doses 28 days apart
Biological : Single-dose Quadrivalent Influenza Vaccine

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment301
Completion DateSeptember 04, 2018
Eligibility Criteria: Inclusion Criteria:
- Aged 6 months to 17 years on the day of inclusion
- Assent form has been signed and dated by the subject aged 7 to 17 years, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
- Subject and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
- Covered by health insurance, if required by local regulations

Exclusion Criteria:
- Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche .
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, device, or medical procedure
- Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before the first study vaccination to 2 weeks following the last study vaccination
- Previous vaccination against influenza (in the preceding 6 months) with either the study vaccine or another vaccine for subjects aged 9 to 17 years.
- For subjects aged 6 months to 8 years:
- Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another vaccine
- Any previous laboratory confirmed influenza infection
- 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)
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances
- Laboratory-confirmed / self-reported / reported by the parent(s) / legally acceptable representative Thrombocytopenia, contraindicating 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
- Current alcohol abuse or drug addiction
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study 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 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.
GenderAll
Age6 Months to 17 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Not Available
Listed Location Countries
Mexico

Administrative Information

NCT Number:NCT03391193
Other Study ID Numbers
GQM00016
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Collaborators
Not Available
Investigators
Study Director
Medical Director
Sanofi Pasteur, a Sanofi Company