Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India

NCT02451358 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: QIV06U1111-1143-8370CTRI/2015/05/005770
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of the study was to generate immunogenicity and safety data in the whole population to support registration of the Quadrivalent Influenza Vaccine (QIV) in India: Primary objective:

• To describe in each age group the immune response induced by a single injection (participants aged \>9 years) or 2 injections (participants aged 6 months to 8 years) of QIV. Secondary objective:
• To describe in each age group the safety profile of QIV.

Conditions

Influenza

Keywords

Influenza; Quadrivalent Inactivated Influenza Vaccine (QIV)

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies

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

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

• Number of Participants With Seroprotection to Influenza Vaccine Antigens

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

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

• Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens

  Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<10 (1/dil) and post-vaccination titer \>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \>=10 (1/dil) and \>= 4-fold increase of post-vaccination titer.

  28 days post-final vaccination (post-vaccination)

Secondary Outcomes (1)

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine

  Within 7 days after any vaccination

Study Arms (4)

Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months

EXPERIMENTAL

Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.

Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative

Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years

EXPERIMENTAL

Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.

Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative

Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years

EXPERIMENTAL

Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.

Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative

Quadrivalent Influenza Vaccine Group 4: >=18 Years

EXPERIMENTAL

Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.

Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative

Interventions

Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Also known as: QIV, No Preservative

Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years

Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Also known as: QIV, No Preservative

Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years

Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative BIOLOGICAL

0.5 mL, Intramuscular

Also known as: QIV, No Preservative

Quadrivalent Influenza Vaccine Group 4: >=18 Years

Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative BIOLOGICAL

0.25 mL, Intramuscular

Also known as: QIV, No Preservative

Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months

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:

• For participants aged 6 to 35 months only: born at full term of pregnancy (\>=37 weeks) or birth weight \>=2.5 kg or both
• Informed consent form had been signed and dated by the participants / participants' parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations. For participants aged 7 to 17 years of age, assent form has been signed and dated by the participants
• Participants / participants' parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures

You may not qualify if:

• For participants aged 9 years or older only: participant was pregnant, 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 in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination (except Oral Poliomyelitis Vaccine (OPV) received during national immunization days)
• For participants aged 9 years or older only: previous vaccination against influenza (in the previous 9 months) with any influenza vaccine
• For participants aged 6 months to 8 years only: previous priming with any influenza vaccine (i.e., participants who received 2 doses for at least 1 previous influenza season)
• 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 any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• Self-reported thrombocytopenia or as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• For participants aged 9 years or older only: current alcohol abuse or drug addiction
• Chronic illness that, in the opinion of the Investigator, was 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 \>=38.0 degree Celsius). A prospective participants should not be included in the study until the condition had 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, 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (8)

Unknown Facility

Vadodara, Gujarat, 390001, India

Location

Unknown Facility

Mandya, Karnataka, 571401, India

Location

Unknown Facility

Pune, Maharashtra, 411043, India

Location

Unknown Facility

Mumbai, Parel, 400012, India

Location

Unknown Facility

Pimpri, Pune, 411018, India

Location

Unknown Facility

Ludhiana, Punjab, 141008, India

Location

Unknown Facility

Kolkata, West Bengal, 700017, India

Location

Unknown Facility

Bangalore, 560054, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; 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 SA

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 22, 2015
• Study Start: July 27, 2015
• Primary Completion: January 28, 2017
• Study Completion: January 28, 2017
• Last Updated: April 19, 2022
• Results First Posted: March 1, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

IN (8)