InfluenzaPhase 3NCT02451358

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

A Phase 3 study testing Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative and Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 8 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative and Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 8 sitesIndia
Study dates: 27 Jul 2015to 28 Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

India8 sites

Study site
Bangalore, 560054
Study site
Kolkata, West Bengal, 700017
Study site
Ludhiana, Punjab, 141008
Study site
Mandya, Karnataka, 571401
Study site
Mumbai, Parel, 400012
Study site
Pimpri, Pune, 411018
Study site
Pune, Maharashtra, 411043
Study site
Vadodara, Gujarat, 390001

Other trials in India

About this study

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

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.

Read the 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.

Conditions: Influenza
Being tested: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative, Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative
Keywords: Influenza, Quadrivalent Inactivated Influenza Vaccine (QIV)
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No PreservativeBiological
Also called QIV, No Preservative
0.25 mL, Intramuscular
Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No PreservativeBiological
Also called QIV, No Preservative
0.5 mL, Intramuscular
Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No PreservativeBiological
Also called QIV, No Preservative
0.5 mL, Intramuscular
Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No PreservativeBiological
Also called QIV, No Preservative
0.5 mL, Intramuscular

Study groups in NCT02451358
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
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])
1. 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)
Measured: Within 7 days after any vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 201528 Jan 2017

First posted22 May 2015 (estimated)
Study start27 Jul 2015
Primary completion28 Jan 2017
Study completion28 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02451358
Sponsor's protocol ID: QIV06
Other IDs: U1111-1143-8370, CTRI/2015/05/005770
Status last verified: Mar 2022
First submitted: 14 May 2015
Last updated: 19 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02451358
Acronym / sponsor ID: QIV06
Conditions: Influenza
Keywords: Influenza, Quadrivalent Inactivated Influenza Vaccine (QIV)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 27 Jul 2015
Primary completion: 28 Jan 2017 (actual)
Study completion: 28 Jan 2017 (actual)
First posted: 22 May 2015 (estimated)
Results: Posted 1 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	Experimental	Biological: Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No PreservativeParticipants 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.
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	Experimental	Biological: Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No PreservativeParticipants 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.
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	Experimental	Biological: Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No PreservativeParticipants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
Quadrivalent Influenza Vaccine Group 4: >=18 Years	Experimental	Biological: Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No PreservativeParticipants aged >=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No PreservativeAlso: QIV, No Preservative0.25 mL, Intramuscular	Biological	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No PreservativeAlso: QIV, No Preservative0.5 mL, Intramuscular	Biological	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No PreservativeAlso: QIV, No Preservative0.5 mL, Intramuscular	Biological	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No PreservativeAlso: QIV, No Preservative0.5 mL, Intramuscular	Biological	Quadrivalent Influenza Vaccine Group 4: >=18 Years

Primary outcome

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.

1 secondary outcome

Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Time frame: Within 7 days after any vaccination

Results and safety

Results posted to the registry on 1 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	100	99
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	100	98
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	100	99
Quadrivalent Influenza Vaccine Group 4: >=18 Years	100	100

Primary outcome: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies

Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination). Geometric mean (95% Confidence Interval). Unit: Titers (1/dilutions)

Measure	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months n = 99	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years n = 98	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years n = 99	Quadrivalent Influenza Vaccine Group 4: >=18 Years n = 100
Pre-Vaccination: A/H1N1	14.4 (9.83 to 21.1)	84.1 (53.6 to 132)	107 (83.4 to 138)	44.3 (31.8 to 61.6)
Pre-Vaccination: A/H3N2	44.4 (26.6 to 74.2)	416 (311 to 555)	204 (150 to 277)	20.8 (15.8 to 27.3)
Pre-Vaccination: B Victoria	21.5 (14.0 to 32.8)	37.5 (23.8 to 59.1)	54.1 (41.4 to 70.6)	41.9 (31.9 to 55.0)
Pre-Vaccination: B Yamagata	12.0 (8.82 to 16.3)	81.1 (53.9 to 122)	91.7 (67.2 to 125)	107 (79.5 to 144)
Post-Vaccination: A/H1N1	723 (527 to 993)	1895 (1550 to 2318)	1641 (1398 to 1927)	1232 (969 to 1565)
Post-Vaccination: A/H3N2	1016 (697 to 1482)	3458 (3011 to 3971)	2379 (1994 to 2838)	980 (736 to 1306)
Post-Vaccination: B Victoria	658 (441 to 982)	2222 (1820 to 2713)	2061 (1622 to 2617)	1150 (913 to 1447)
Post-Vaccination: B Yamagata	951 (675 to 1338)	3582 (3054 to 4201)	2273 (1750 to 2951)	1836 (1413 to 2385)

Population analysed: Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.

Primary outcome: Number of Participants With Seroprotection to Influenza Vaccine Antigens

Time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination). Count of participants. Unit: Participants

Measure	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months n = 99	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years n = 98	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years n = 99	Quadrivalent Influenza Vaccine Group 4: >=18 Years n = 100
Pre-Vaccination: A/H1N1	23	62	86	60
Pre-Vaccination: A/H3N2	40	94	85	34
Pre-Vaccination: B Victoria	30	47	63	53
Pre-Vaccination: B Yamagata	18	65	74	83
Post-Vaccination: A/H1N1	93	98	99	99
Post-Vaccination: A/H3N2	96	98	99	96
Post-Vaccination: B Victoria	88	98	98	99
Post-Vaccination: B Yamagata	93	98	98	97

Population analysed: Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.

Primary outcome: Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens

Time frame: 28 days post-final vaccination (post-vaccination). Count of participants. Unit: Participants

Measure	Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months n = 99	Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years n = 98	Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years n = 99	Quadrivalent Influenza Vaccine Group 4: >=18 Years n = 100
A/H1N1	86	87	84	90
A/H3N2	85	77	71	90
B Victoria	84	87	95	92
B Yamagata	91	91	86	86

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months	0 of 100 (0%)	29 of 100 (29%)	0 of 100
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years	0 of 100 (0%)	50 of 100 (50%)	0 of 100
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years	0 of 100 (0%)	44 of 100 (44%)	0 of 100
Quadrivalent Influenza Vaccine Group 4: >=18 Years	0 of 100 (0%)	24 of 100 (24%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

Related trials for Influenza

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur SA

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (time frame: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02451358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.