Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines

NCT03308825 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: GRC73U1111-1183-5816
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of the study was to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone Quadrivalent vaccine in children 6 months to \< 9 years of age, and in adults 18 to \< 65 years of age, and to describe the safety and immunogenicity of the 2017-2018 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Conditions

Influenza; Flu

Keywords

Influenza; Flu

Outcome Measures

Primary Outcomes (10)

• Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)

  Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling \>= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: \>= 39.5 degrees Celsius \[103.1 degree Fahrenheit {°F}\], vomiting \>= six episodes per 24 hours, abnormal crying : \> 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses \>= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).

  Within 7 days after any vaccination

• Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)

  Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema \& swelling (Group 2: Grade 3: \>= 50 mm, Group 3 and 4: Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 3: \>= 39.0 degrees Celsius \[102.2°F\]), headache, malaise \& myalgia (Grade 3: significant interference with daily activities).

  Within 7 days after any vaccination

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)

  Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.

  Day 0 (pre-vaccination) and Day 28 (post-vaccination)

• GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)

  Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).

  Day 0 (pre-vaccination) and Day 21 (post-vaccination)

• GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)

  GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.

  Day 0 (pre-vaccination) and Day 28 (post-final vaccination)

• GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)

  GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.

  Day 0 (pre-vaccination) and Day 21 (post-vaccination)

• Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)

  Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer \>=40 (1/ dilution) at pre-vaccination or at post-final vaccination.

  Day 0 (pre-vaccination) and Day 28 (post-vaccination)

• Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)

  Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer \>= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.

  Day 0 (pre-vaccination) and Day 21 (post-vaccination)

• Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)

  Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.

  Day 0 (pre-vaccination) and Day 28 (post-final vaccination)

• Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)

  Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-final vaccination titer \>= 1:40 or a pre-vaccination titer \>= 1:10 and at least a 4-fold increase in post-final vaccination titer.

  Day 0 (pre-vaccination) and Day 21 (post-vaccination)

Study Arms (4)

Group 1: 6 to < 36 Months

EXPERIMENTAL

Children aged 6 to \< 36 months received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.

Biological: Fluzone Quadrivalent vaccine

Group 2: 3 to < 9 Years

EXPERIMENTAL

Children aged 3 to \< 9 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered on Day 28.

Biological: Fluzone Quadrivalent vaccine

Group 3: 18 to < 65 Years

EXPERIMENTAL

Adults aged 18 to \< 65 years received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0.

Biological: Fluzone Quadrivalent vaccine

Group 4: >= 65 Years

EXPERIMENTAL

Adults aged \>= 65 years received a 0.5-mL dose of Fluzone High-Dose vaccine, intramuscularly, at Day 0.

Biological: Fluzone High-Dose vaccine

Interventions

Fluzone Quadrivalent vaccine BIOLOGICAL

0.25 mL, Intramuscular

Group 1: 6 to < 36 Months

Fluzone High-Dose vaccine BIOLOGICAL

0.5 mL, Intramuscular

Group 4: >= 65 Years

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:

• Aged 6 months to \< 9 years or ≥ 18 years on the day of first study vaccination (study product administration).
• For participants 6 to \< 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
• Informed consent form has been signed and dated by participants ≥ 18 years of age.
• Assent form was signed and dated by participants 7 to \< 9 years of age, and informed consent form has been signed and dated by parent(s) or guardian(s) for participants 6 months to \< 9 years of age.
• Participant and parent/guardian (of participants 6 months to \< 9 years of age) were able to attend all scheduled visits and to comply with all study procedures.

You may not qualify if:

• Participant was 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 and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post- menopausal for at least 1 year, or surgically sterile.
• Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Note: Participants may be considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the participant would complete safety surveillance for the present study.
• Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
• Previous vaccination against influenza (in the 2017-2018 influenza season) with either study vaccine or another vaccine.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to study vaccine or to a vaccine containing any of the same substances. Note: The list of vaccine components is included in the Prescribing Information for each study vaccine.
• Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
• 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, was 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 planned vaccination or febrile illness (temperature ≥ 100.4 degree Fahrenheit \[°F\] \[38.0 degrees Celsius {°C}\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (participants ≥ 18 years of age) 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 (all participants).
• History of serious adverse reaction to any influenza vaccine.
• Personal history of Guillain-Barré syndrome.
• Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine.
• Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Sanofi Pasteur Investigational Site 003

Council Bluffs, Iowa, 51503, United States

Location

Sanofi Pasteur Investigational Site 002

Bardstown, Kentucky, 40004, United States

Location

Sanofi Pasteur Investigational Site 001

Metairie, Louisiana, 70006, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  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

Model Details: Multicenter, Open-label, Phase IV Study

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 13, 2017
• Study Start: September 11, 2017
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: March 29, 2022
• Results First Posted: December 17, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (3)