Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India
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ClinicalTrials.gov Identifier: NCT02451358 |
Recruitment Status :
Completed
First Posted : May 22, 2015
Results First Posted : March 1, 2018
Last Update Posted : April 19, 2022
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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 |
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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 |
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 |

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.
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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.
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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.
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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 |
- 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.
- 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.
- 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.
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine [ Time Frame: Within 7 days after any vaccination ]
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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])
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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)
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Ages Eligible for Study: | 6 Months and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451358
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 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Documents provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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 Key Record Dates |
Results First Posted: | March 1, 2018 |
Last Update Posted: | April 19, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
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 |
Influenza Quadrivalent Inactivated Influenza Vaccine (QIV) |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |