InfluenzaPhase 1/2NCT02035696

Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

A Phase 1/2 study testing Trivalent influenza vaccine (TIVc) and Trivalent influenza vaccine-licensed in people with Influenza, run by Seqirus at 27 sites in 4 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

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age Read more about this study

Who is it for?: Ages 6 to 48 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Trivalent influenza vaccine (TIVc) and Trivalent influenza vaccine-licensed
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 671 participants
Where: 27 sitesin 4 countries
Study dates: Dec 2013to Dec 2014
Phase: Phase 1/2
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 to 48 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up

Who cannot join

Individuals recently vaccinated against influenza
Subjects with contraindications to receive influenza vaccine

Trial locations and contacts

27 sites in 4 countries.

Country

City, postcode or hospital

27 sites in 4 countries

United States21 sites

Site 102
Charleston, South Carolina
Site 121
Gainesville, Georgia
Site 115
Houston, Texas
Site 109
Little Rock, Arkansas
Site 112
Long Beach, California
Site 111
Miami, Florida
Site 108
Miami Beach, Florida
Site 101
Omaha, Nebraska
Site 104
Omaha, Nebraska
Site 105
Omaha, Nebraska
Site 106
Omaha, Nebraska
Site 113
Ontario, California
Site 116
Phoenix, Arizona
Site 110
Salt Lake City, Utah
Site 117
San Diego, California
Site 120
Spokane, Washington
Site 118
St. George, Utah
Site 107
Thornton, Colorado
Site 119
Tucson, Arizona
Site 114
West Covina, California
Site 103
Youngstown, Ohio

Other trials in United States

Finland2 sites

Site 502
Kuopio
Site 506
Tampere

Other trials in Finland

Philippines2 sites

Site 302
City of Muntinlupa
Site 301
Manila

Other trials in Philippines

Thailand2 sites

Site 201
Bangkok
Site 202
Bangkok

Other trials in Thailand

About this study

Official title: A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age

Conditions: Influenza
Being tested: Trivalent influenza vaccine (TIVc), Trivalent influenza vaccine-licensed
Keywords: influenza, children, safety, tolerability, immunogenicity
Medical subject headings: Influenza, Human

What participants receive

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

Trivalent influenza vaccine (TIVc)Biological
Trivalent influenza vaccine-licensedBiological
Licensed influenza vaccine

Study groups in NCT02035696
Study group	Role	What they receive
TIVc-High Dose	Experimental	Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine Receives: Biological: Trivalent influenza vaccine (TIVc)
TIVc-Full Dose	Experimental	Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine Receives: Biological: Trivalent influenza vaccine (TIVc)
TIVc- Half Dose	Experimental	Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine Receives: Biological: Trivalent influenza vaccine (TIVc)
TIVe	Active comparator	Subjects (6 to <48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to <36 months and IM/ 0.5 mL -for ages 36 to <48 months) Receives: Biological: Trivalent influenza vaccine-licensed

What is being measured

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

Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Measured: Day 50/Day 1
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
Measured: Day 50 post vaccination
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.
Measured: Day 1 to Day 3

Secondary outcomes (9)

Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%
The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%
Measured: Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%
The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%
Measured: Day 1, Day 50 post vaccination
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
The CHMP criterion is mean geometric ratio (GMR) >2.5
Measured: Day 50 post vaccination over day 1
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Measured: Day 50 post vaccination over day 1
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Measured: Day 1 and Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
Measured: Day 1 and Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
Measured: Day 1 and Day 50 post vaccination
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Measured: Day 1 to Day 7
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Measured: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209

Timeline

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

Dec 2013Dec 2014

First posted14 Jan 2014 (estimated)
Study startDec 2013
Primary completionJun 2014
Study completionDec 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.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 671 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02035696
Sponsor's protocol ID: V58P16
Other IDs: 2013-002081-39
Status last verified: Jun 2018
First submitted: 7 Jan 2014
Last updated: 10 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.
ClinicalTrials.gov ID: NCT02035696
Acronym / sponsor ID: V58P16
Conditions: Influenza
Keywords: influenza, children, safety, tolerability, immunogenicity
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 671 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Dec 2013
Primary completion: Jun 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 14 Jan 2014 (estimated)
Results: Posted 27 Jun 2017

Clinical summary

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

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TIVc-High Dose	Experimental	Biological: Trivalent influenza vaccine (TIVc)Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine
TIVc-Full Dose	Experimental	Biological: Trivalent influenza vaccine (TIVc)Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine
TIVc- Half Dose	Experimental	Biological: Trivalent influenza vaccine (TIVc)Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine
TIVe	Active comparator	Biological: Trivalent influenza vaccine-licensedSubjects (6 to <48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to <36 months and IM/ 0.5 mL -for ages 36 to <48 months)

Who may qualify

Ages: 6 to 48 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up

Key exclusion criteria (2 listed)

Individuals recently vaccinated against influenza
Subjects with contraindications to receive influenza vaccine

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
Trivalent influenza vaccine (TIVc)	Biological	TIVc- Half Dose, TIVc-Full Dose, TIVc-High Dose
Trivalent influenza vaccine-licensedLicensed influenza vaccine	Biological	TIVe

Primary outcome

Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 50/Day 1
Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 50 post vaccination
Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine
Time frame: Day 1 to Day 3
Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.

9 secondary outcomes

Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 1, Day 50 post vaccination
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 50 post vaccination over day 1
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 50 post vaccination over day 1
Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 1 and Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 1 and Day 50 post vaccination
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 1 and Day 50 post vaccination
Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Time frame: Day 1 to Day 7
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine
Time frame: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209

Results and safety

Results posted to the registry on 27 Jun 2017, 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-High Dose	174	171
TIVc-Full Dose	166	163
TIVc- Half Dose	167	164
TIVe	164	161

Primary outcome: Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine

Time frame: Day 50/Day 1. Number (95% Confidence Interval). Unit: Ratios

Measure	TIVc-High Dose n = 156	TIVc-Full Dose n = 147	TIVc- Half Dose n = 141	TIVe n = 145
A/H1N1	7.82 (4.3 to 14.21)	5.5 (3.01 to 10.04)	5.93 (3.21 to 10.96)	3.69 (2.02 to 6.74)
A/H3N2	10.53 (6.34 to 17.49)	10.84 (6.5 to 18.07)	6.47 (3.84 to 10.9)	11.95 (7.17 to 19.91)
B	5.18 (3.73 to 7.96)	4.27 (2.77 to 6.58)	3.87 (2.49 to 6.02)	6.65 (4.32 to 10.25)

TIVc-High Dose vs TIVe: Vaccine Group Ratios at Day 1: 0.99 (95% CI 0.65 to 1.52)
TIVc-High Dose vs TIVe: Vaccine Group ratios at Day 50: 2.11 (95% CI 1.5 to 2.98)
TIVc-High Dose vs TIVe: Vaccine Group ratios at Day 1: 0.68 (95% CI 0.43 to 1.06)

Population analysed: Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis

Primary outcome: Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine

Time frame: Day 50 post vaccination. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	TIVc-High Dose n = 156	TIVc-Full Dose n = 147	TIVc- Half Dose n = 141	TIVe n = 145
A/H1N1_Day 50	83 (77 to 89)	81 (74 to 87)	79 (72 to 86)	74 (66 to 81)
A/H3N2_Day 50	94 (89 to 97)	90 (84 to 94)	87 (80 to 92)	92 (87 to 96)
B_Day 50	69 (61 to 76)	69 (61 to 77)	62 (54 to 70)	80 (73 to 86)

TIVc-High Dose vs TIVe: Vaccine Group Differences: 10 (95% CI 0 to 18.9)
TIVc-High Dose vs TIVe: Vaccine Group Differences: 2 (95% CI -4 to 8)
TIVc-High Dose vs TIVe: Vaccine Group differences: -11 (95% CI -21.1 to -1.5)

Population analysed: Analysis was done on PP population

Primary outcome: Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine

Time frame: Day 1 to Day 3. Number. Unit: percentage of participants

Measure	TIVc-High Dose-TIVe n = 305	TIVc-Full Dose-TIVe n = 294	TIVc- Half Dose-TIVe n = 291
Severe solicited local AEs	0.000	0.000	0.000
Severe solicited systemic AEs	0.040	0.000	0.000

TIVc-High Dose-TIVe: Desirability Index Score: 0.000
TIVc-Full Dose-TIVe: Desirability Index Score: 0.000
TIVc- Half Dose-TIVe: Desirability Index Score: 0.000

Population analysed: Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period, up to day 209 post vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIVc-High Dose	4 of 174 (2.3%)	142 of 174 (81.6%)	Not reported
TIVc-Full Dose	8 of 166 (4.8%)	133 of 166 (80.1%)	Not reported
TIVc- Half Dose	10 of 167 (6%)	141 of 167 (84.4%)	Not reported
TIVe	6 of 164 (3.7%)	127 of 164 (77.4%)	Not reported
Total	28 of 671 (4.2%)	543 of 671 (80.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

27 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Trivalent influenza vaccine (TIVc) and Trivalent influenza vaccine-licensed in people with Influenza, run by Seqirus at 27 sites in 4 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 2 inclusion and 2 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Finland, Philippines, Thailand. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 27 Jun 2017). 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?

Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine (time frame: Day 50/Day 1). 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 NCT02035696.

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 10 Jul 2018.