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

• ClinicalTrials.gov Identifier: NCT02451358
• Recruitment Status: Completed
• First Posted: May 22, 2015
• Results First Posted: March 1, 2018
• Last Update Posted: March 1, 2018
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative; Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative	Phase 3

Detailed Description:

All participants were vaccinated with the QIV (split-virion, inactivated) Northern Hemisphere (NH) or Southern Hemisphere (SH) formulations by the intramuscular (IM) route. Immunogenicity of the vaccine was assessed at baseline (Day 0) and 28 days after the last injection. Safety data were collected up to 28 days after each injection. Serious adverse events (SAEs) were collected throughout the trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of a Single Dose or Two Doses Given 28 Days Apart of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 6 Months or Older in India
• Study Start Date: July 27, 2015
• Actual Primary Completion Date: January 28, 2017
• Actual Study Completion Date: January 28, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months; 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; 0.25 mL, Intramuscular; Other Name: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years; 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; 0.5 mL, Intramuscular; Other Name: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years; 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; 0.5 mL, Intramuscular; Other Name: QIV, No Preservative
Experimental: Quadrivalent Influenza Vaccine Group 4: >=18 Years; 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; 0.5 mL, Intramuscular; Other Name: QIV, No Preservative

Outcome Measures

Primary Outcome Measures :

1. Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies [ Time Frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) ]
   Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
2. Number of Participants With Seroprotection to Influenza Vaccine Antigens [ Time Frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination) ]
   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.
3. Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens [ Time Frame: 28 days post-final vaccination (post-vaccination) ]
   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.

Secondary Outcome Measures :

1. Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine [ Time Frame: Within 7 days after any vaccination ]

   1. Solicited injection site reactions:

      • Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm)
      • Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years])

   2. Solicited systemic reactions:

      • Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable)
      • Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Aged 6 months or older on the day of inclusion
• 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

Exclusion Criteria:

• 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
• 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
• 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

Contacts and Locations

Locations

India

Vadodara, Gujarat, India, 390001

Mandya, Karnataka, India, 571401

Pune, Maharashtra, India, 411043

Mumbai, Parel, India, 400012

Pimpri, Pune, India, 411018

Ludhiana, Punjab, India, 141008

Kolkata, West Bengal, India, 700017

Bangalore, India, 560054

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Director; Sanofi Pasteur SA

  Study Documents (Full-Text)

Documents provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Study Protocol  [PDF] September 30, 2015

Statistical Analysis Plan  [PDF] March 4, 2016

More Information

Additional Information:

Related Info 

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT02451358
• Other Study ID Numbers: QIV06; U1111-1143-8370 ( Other Identifier: WHO ); CTRI/2015/05/005770 ( Other Identifier: CTR-India )
• First Posted: May 22, 2015
• Results First Posted: March 1, 2018
• Last Update Posted: March 1, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Influenza; Quadrivalent Inactivated Influenza Vaccine (QIV)

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs