InfluenzaPhase 3NCT01857206

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

A Phase 3 study testing Mammalian cell based flu vaccine and Egg based flu vaccine in people with Influenza and Fever, run by Novartis Vaccines at 34 sites in 5 countries.

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

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age. Read more about this study

Who is it for?: Ages 4 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Fever
What is being tested?: Mammalian cell based flu vaccine and Egg based flu vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,055 participants
Where: 34 sitesin 5 countries
Study dates: May 2013to Jun 2014
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 4 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy subjects 4-17 years of age

Who cannot join

Subjects who are not healthy,
Subjects who are pregnant or breast feeding,
Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Trial locations and contacts

34 sites in 5 countries.

Country

City, postcode or hospital

34 sites in 5 countries

United States18 sites

313, Novartis Investigational Site
Augusta, Kansas, 67010
310, Novartis Investigational Site
Bristol, Tennessee, 37620
317, Novartis Investigational Site
Cleveland, Ohio, 44121
311, Novartis Investigational Site
Fremont, Nebraska, 68025
320, Novartis Investigational Site
Mobile, Alabama, 36608
319, Novartis Investigational Site
Mt. Pleasant, South Carolina, 29464
318, Novartis Investigational Site
Nashville, Tennessee, 37203
305, Novartis Investigational Site
Newton, Kansas, 67114
312, Novartis Investigational Site
Ponte Vedra, Florida, 32081
304, Novartis Investigational Site
Salt Lake City, Utah, 84109
306, Novartis Investigational Site
Salt Lake City, Utah, 84121
315, Novartis Investigational Site
Salt Lake City, Utah, 84124
303, Novartis Investigational Site
South Jordan, Utah, 84095
309, Novartis Investigational Site
Tulsa, Oklahoma, 74127
314, Novartis Investigational Site
Warwick, Rhode Island, 02886
302, Novartis Investigational Site
Wichita, Kansas, 67205
301, Novartis Investigational Site
Wichita, Kansas, 67207
308, Novartis Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Australia6 sites

108, Novartis Investigational Site
Auchenflower, Queensland, 4066
103, Novartis Investigational Site
Carlton, Victoria, 3010
104, Novartis Investigational Site
North Adelaide, South Australia, 5006
107, Novartis Investigational Site
Sherwood, Queensland, 4075
105, Novartis Investigational Site
Subiaco, Western Australia, 6008
100, Novartis Investigational Site
Westmead, New South Wales, 2145

Other trials in Australia

Philippines5 sites

250, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781
251, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781
254, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781
253, Novartis Investigational Site
Manila, Ermita, 1001
252, Novartis Investigation Site
Manila, Sampaloc, 1001

Other trials in Philippines

Thailand3 sites

200, Novartis Investigational Site
Bangkok, Rajathevi, 10400
202, Novartis Investigational Site
Bangkoknoi, Siriraj, 10700
201, Novartis Investigational Site
Khon Kaen, Muang, 40002

Other trials in Thailand

New Zealand2 sites

150, Novartis Investigational Site
Beckenham, Christchurch, 8024
151, Novartis Investigational Site
Takapuna, Auckland, 0622

Other trials in New Zealand

About this study

Official title: A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Conditions: Influenza, Fever
Being tested: Mammalian cell based flu vaccine, Egg based flu vaccine
Keywords: Influenza, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs
Medical subject headings: Influenza, Human, Fever

What participants receive

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

Mammalian cell based flu vaccineBiological
Egg based flu vaccineBiological

Study groups in NCT01857206
Study group	Role	What they receive
TIVc	Experimental	Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status. Receives: Biological: Mammalian cell based flu vaccine
TIVf	Active comparator	Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status. Receives: Biological: Egg based flu vaccine

What is being measured

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

Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Measured: Day 1 to Day 7 after any vaccination
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Measured: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
Measured: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Timeline

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

May 2013Jun 2014

First posted20 May 2013 (estimated)
Study startMay 2013
Primary completionJun 2014
Study completionJun 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
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: Single blind
Who is masked: Participant
Enrolment: 2,055 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01857206
Sponsor's protocol ID: V58_31
Other IDs: U1111-1139-9440
Status last verified: Nov 2014
First submitted: 16 May 2013
Last updated: 5 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.
PubMed 26643931

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 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.
ClinicalTrials.gov ID: NCT01857206
Acronym / sponsor ID: V58_31
Conditions: Influenza, Fever
Keywords: Influenza, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,055 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 20 May 2013 (estimated)
Results: Posted 3 Nov 2014

Clinical summary

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

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TIVc	Experimental	Biological: Mammalian cell based flu vaccineSubjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
TIVf	Active comparator	Biological: Egg based flu vaccineSubjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Who may qualify

Ages: 4 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy subjects 4-17 years of age

Key exclusion criteria (3 listed)

Subjects who are not healthy,
Subjects who are pregnant or breast feeding,
Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

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
Mammalian cell based flu vaccine	Biological	TIVc
Egg based flu vaccine	Biological	TIVf

Primary outcome

Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Time frame: Day 1 to Day 7 after any vaccination
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time frame: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Time frame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.

Results and safety

Results posted to the registry on 3 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIVc	1,372	1,359
TIVf	683	673

Primary outcome: Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.

Time frame: Day 1 to Day 7 after any vaccination. Number. Unit: Subjects

Measure	TIVc (≥4 to ≤8 Years) n = 688	TIVf (≥4 to ≤8 Years) n = 341	TIVc (≥9 to ≤17 Years) n = 682	TIVf (≥9 to ≤17 Years) n = 341
Any Local	422	202	370	160
Injection site Induration (AE)	109	43	46	33
Injection site Swelling (AE)	87	37	36	26
Injection site Erythema (AE)	148	57	72	37
Injection site Ecchymosis (AE)	68	30	27	11
Injection site Pain (AE)	384	186	356	142
Any Systemic	252	110	267	113
Chills (AE)	47	17	39	7

Population analysed: Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.

Primary outcome: Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

Time frame: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.. Number. Unit: Subjects

Measure	TIVc (≥4 to ≤8 Years) n = 688	TIVf (≥4 to ≤8 Years) n = 340	TIVc (≥9 to ≤17 Years) n = 681	TIVf (≥9 to ≤17 Years) n = 341
Any AE	277	139	158	88
At least possibly related AE	50	26	32	22

Population analysed: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Primary outcome: Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.

Time frame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects. Number. Unit: Subjects

Measure	TIVc (≥4 to ≤8 Years) n = 688	TIVf (≥4 to ≤8 Years) n = 340	TIVc (≥9 to ≤17 Years) n = 681	TIVf (≥9 to ≤17 Years) n = 341
SAE	17	7	7	9
At least possibly related SAE	0	0	0	0
AE leading to withdrawal	0	0	0	0
Medically attended AE	284	139	172	105
NOCD	5	4	3	1
Death	0	0	0	0

Population analysed: Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Adverse events

Time frame: 6 months for subjects aged ≥4 to ≤8 years previously vaccinated and all subjects aged ≥9 to ≤17 Years 7 months for subjects aged ≥4 to ≤8 years not previously vaccinated.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIVc(4-8Years )	17 of 688 (2.5%)	545 of 688 (79.2%)	Not reported
TIVf(4-8Years )	7 of 341 (2.1%)	267 of 341 (78.3%)	Not reported
TIVc(9-17Years )	7 of 682 (1%)	489 of 682 (71.7%)	Not reported
TIVf(9-17Years )	9 of 341 (2.6%)	220 of 341 (64.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26643931Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.

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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.

Novartis Vaccines and Diagnostics study chair

Novartis Vaccines

34 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mammalian cell based flu vaccine and Egg based flu vaccine in people with Influenza and Fever, run by Novartis Vaccines at 34 sites in 5 countries.

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 1 inclusion and 3 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Australia, Philippines, Thailand, New Zealand. 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 3 Nov 2014). 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?

Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. (time frame: Day 1 to Day 7 after any 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 NCT01857206, which also lists 1 linked publication.

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 5 Dec 2014.