InfluenzaPhase 4NCT02228980

Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

A Phase 4 study testing Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site in China.

Completed

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

Official record

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Trial summary

The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV). 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?: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 602 participants
Where: 1 siteChina
Study dates: Sep 2014to Oct 2015
Phase: Phase 4
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 on the day of inclusion
Informed Consent Form has been signed and dated:
by the parent(s) or legally acceptable representative, if applicable, for subjects <18 years of age. Additionally, an assent form has been signed by the subject if aged 10 to 17 years (based on local regulations).
by the subject himself/herself for subjects ≥18 years of age.
Subject and parent(s)/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
For subjects aged 3-8 years only: Subject has previously received at least one dose of influenza vaccine in the past years or has a history of prior exposure to influenza virus through natural infection.

Who cannot join

Subject is pregnant (positive urine pregnancy test), 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 or planned receipt of any vaccine within the period from 2 weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the period from 2 weeks before the first trial vaccination to 2 weeks after the second trial vaccination (subjects aged 6-35 months)
For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2 consecutive doses of influenza vaccine [same seasonal strain composition]) any time prior to study enrollment or history of prior exposure to influenza virus through natural infection
Vaccination against influenza given in the past 6 months with any influenza vaccine or planned receipt of influenza vaccination during the present study
Receipt of immune globulins, blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

Show all 17Show 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)
Reported history of seropositivity for Human Immunodeficiency Virus (HIV), after questioning the subject or the subject's parents or another legally acceptable representative
Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substance
Self-reported thrombocytopenia, as reported by the subject, parent or legally acceptable representative contraindicating intramuscular vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination upon investigator's judgment
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Chronic illness that, in the opinion of the investigator, is 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 ≥37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
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

1 site in 1 country.

China1 site

Study site
Nanning, Guangxi

Other trials in China

About this study

Official title: Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

Primary objective:

To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

Secondary objective:

To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Read the detailed description

Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).

Conditions: Influenza
Being tested: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Keywords: Influenza, Trivalent influenza vaccine, Sanofi Pasteur Shenzhen trivalent influenza vaccine
Medical subject headings: Influenza, Human

What participants receive

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

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationBiological
0.25 mL Intramuscular (2 doses given 28 days apart)
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationBiological
0.5 mL Intramuscular
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationBiological
0.5 mL Intramuscular
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationBiological
0.5 mL Intramuscular

Study groups in NCT02228980
Study group	Role	What they receive
Subjects aged 6 to 35 months (Group 1)	Experimental	Participants aged 6 months to 35 months will receive two 0.25 mL doses of SP Shz TIV given 28 days apart. Receives: Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Subjects aged 3 to 17 years (Group 2)	Experimental	Participants aged 3 years to 17 years will receive a single 0.5 mL dose of SP Shz TIV Receives: Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Subjects aged 18 to 60 years (Group 3)	Experimental	Participants aged 18 years to 60 years will receive a single 0.5 mL dose of SP Shz TIV Receives: Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
Subjects aged 61 years or older (Group 4)	Experimental	Participants aged 61 years or older will receive a single 0.5 mL dose of SP Shz TIV Receives: Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

What is being measured

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

Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination

Timeline

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

Sep 2014Oct 2015

First posted29 Aug 2014 (estimated)
Study startSep 2014
Primary completionDec 2014
Study completionOct 2015

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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 602 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02228980
Sponsor's protocol ID: FST01
Other IDs: U1111-1143-8684, CTR20140452
Status last verified: Dec 2015
First submitted: 26 Aug 2014
Last updated: 29 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China
ClinicalTrials.gov ID: NCT02228980
Acronym / sponsor ID: FST01
Conditions: Influenza
Keywords: Influenza, Trivalent influenza vaccine, Sanofi Pasteur Shenzhen trivalent influenza vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 602 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Dec 2014 (actual)
Study completion: Oct 2015 (actual)
First posted: 29 Aug 2014 (estimated)
Results: Posted 29 Jan 2016

Clinical summary

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

Primary objective:

To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

Secondary objective:

To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Detailed description

Study design

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

Arm	Type	Receives
Subjects aged 6 to 35 months (Group 1)	Experimental	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationParticipants aged 6 months to 35 months will receive two 0.25 mL doses of SP Shz TIV given 28 days apart.
Subjects aged 3 to 17 years (Group 2)	Experimental	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationParticipants aged 3 years to 17 years will receive a single 0.5 mL dose of SP Shz TIV
Subjects aged 18 to 60 years (Group 3)	Experimental	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationParticipants aged 18 years to 60 years will receive a single 0.5 mL dose of SP Shz TIV
Subjects aged 61 years or older (Group 4)	Experimental	Biological: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulationParticipants aged 61 years or older will receive a single 0.5 mL dose of SP Shz TIV

Who may qualify

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

Key inclusion criteria (7 listed)

Aged ≥ 6 months on the day of inclusion
Informed Consent Form has been signed and dated:
Subject and parent(s)/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
For subjects aged 3-8 years only: Subject has previously received at least one dose of influenza vaccine in the past years or has a history of prior exposure to influenza virus through natural infection.

Key exclusion criteria (17 listed)

Subject is pregnant (positive urine pregnancy test), 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 or planned receipt of any vaccine within the period from 2 weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the period from 2 weeks before the first trial vaccination to 2 weeks after the second trial vaccination (subjects aged 6-35 months)
For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2 consecutive doses of influenza vaccine [same seasonal strain composition]) any time prior to study enrollment or history of prior exposure to influenza virus through natural infection
Vaccination against influenza given in the past 6 months with any influenza vaccine or planned receipt of influenza vaccination during the present study

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
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation0.25 mL Intramuscular (2 doses given 28 days apart)	Biological	Subjects aged 6 to 35 months (Group 1)
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation0.5 mL Intramuscular	Biological	Subjects aged 3 to 17 years (Group 2)
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation0.5 mL Intramuscular	Biological	Subjects aged 18 to 60 years (Group 3)
Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation0.5 mL Intramuscular	Biological	Subjects aged 61 years or older (Group 4)

Primary outcome

Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
Time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.

Results and safety

Results posted to the registry on 29 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Age 6 to 35 Months Group	150	126
Age 3 to 17 Years Group	150	147
Age 18 to 60 Years Group	151	149
Age ≥61 Years Group	151	148

Primary outcome: Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine

Time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers (1/dilution)

Measure	Age 6 to 35 Months Group n = 150	Age 3 to 17 Years Group n = 150	Age 8 to 60 Years Group n = 151	Age ≥61 Years Group n = 151
A/H1N1 (Pre-dose; N=150,150,151,151)	12.8 (10.5 to 15.6)	24.3 (20.1 to 29.4)	11.2 (9.49 to 13.1)	9 (7.68 to 10.5)
A/H1N1 (Post-dose; N=125,145,149,145)	152.2 (120 to 193)	300.7 (243 to 372)	188.3 (158 to 224)	144 (116 to 180)
A/H3N2 (Pre-dose; n=150,150,151,151)	14.3 (11.3 to 18.1)	62 (51.5 to 74.8)	12.2 (10.4 to 14.4)	21.1 (16.9 to 26.5)
A/H3N2 (Post-dose; N=125,146,149,147)	235.9 (191 to 291)	236.2 (207 to 270)	166.1 (140 to 197)	237.8 (198 to 285)
B (Pre-dose; N=150,150,151,151)	5.9 (5.49 to 6.30)	17.7 (15.0 to 20.9)	16.3 (13.7 to 19.5)	15.3 (12.8 to 18.2)
B (Post-dose; N=123,146,149,148)	108.5 (90.9 to 129)	216.8 (180 to 261)	202.8 (168 to 245)	170 (140 to 207)

Population analysed: Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.

Adverse events

Time frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 56 post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	1 of 150 (0.7%)	38 of 150 (25.3%)	Not reported
Group 2	1 of 150 (0.7%)	52 of 150 (34.7%)	Not reported
Group 3	0 of 151 (0%)	25 of 151 (16.6%)	Not reported
Group 4	1 of 151 (0.7%)	12 of 151 (7.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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

1 site 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 7 inclusion and 17 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 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Jan 2016). 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 of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine (time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination). 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 NCT02228980.

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 29 Jan 2016.