Prophylaxis of A/H3N2v InfluenzaPhase 1NCT01855945

Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.

A Phase 1 study testing Swine Influenza in people with Prophylaxis of A/H3N2v Influenza, run by Novartis Vaccines at 11 sites in United States.

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 the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly 65 years and older. Read more about this study

Who is it for?: Ages 3 to 92 yearsHealthy volunteers can take part
Conditions the study is for: Prophylaxis of A/H3N2v Influenza
What is being tested?: Swine Influenza
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 627 participants
Where: 11 sitesUnited States
Study dates: May 2013to Sep 2014
Phase: Phase 1
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 3 to 92 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Males and females 3 years of age and older
Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
Individuals who can comply with study procedures and are available for follow-up

Who cannot join

Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
Individuals with known or suspected impairment of the immune system including, but not limited to:

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autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
autoimmune disorders;
Systemic therapy with corticosteroids or other immunosuppressive therapy.
Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study
Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
If female, "of childbearing potential", sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
"Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy
Acceptable birth control methods are defined as one or more of the following:
Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
Intrauterine device (IUD);
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
Individuals who are allergic to any of the vaccine components.
For children 17 years of age and younger: Individuals who have had ever a malignancy
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3 days of intended study vaccination
Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
Individuals who have received any prior H3N2v vaccine
Individuals who have received any other type of influenza vaccination (e.g., "seasonal") within 14 days prior to enrolment, or who plans to receive influenza vaccine during the treatment phase of this study (seasonal influenza vaccination is allowed after Day 43/Visit 3)
Individuals who received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study or who are planning to receive any (non-influenza) vaccine within 4 weeks from the study vaccines
Individuals who are research staff involved with the clinical study or family/household members of research staff
Individuals with a BMI > 35 kg/m2 (adults), > 29 kg/m2 (adolescents), or > 21 kg/m2 (children)
Individuals with a history of drug or alcohol abuse within the past 2 years

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

42, Research Acros
Dallas, Texas, 75234
46, Johnson County Clinical Trials
Lenexa, Kansas, 66213
43, Central Kentucky Research Associates
Lexington, Kentucky, 40509
41, Benchmark Research
Metairie, Louisiana, 70006
50, PMG Research of Raleigh
Raleight, North Carolina, 27609
51, Northern California Clinical Research Center
Redding, California, 96001
44, Rochester Clinical Research Inc.
Rochester, New York, 14609
47, Benchmark Research
Sacramento, California, 95822
48, "J. Lewis Research, Inc.
Salt Lake City, Utah, 84109
45, Omega Medical Research
Warwick, Rhode Island, 02886
49, Heartland Research Associates, LLC
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: Phase I Multi-center, Observer-Blind, Randomized, Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated Novel Swine Origin A/H3N2v Monovalent Subunit Influenza Virus Vaccine (H3N2c) in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to < 65 Years and Elderly ≥ 65 Years and Older.

Conditions: Prophylaxis of A/H3N2v Influenza
Being tested: Swine Influenza
Keywords: Influenza
Medical subject headings: Influenza, Human

What participants receive

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

Swine InfluenzaBiological
Comparison of different dosages of vaccines

Study groups in NCT01855945
Study group	Role	What they receive
Group A	Experimental	3.75 µg H3N2c HA + 0.125 mL MF59 Receives: Biological: Swine Influenza
Group B	Experimental	7.5 µg H3N2c HÁ + 0.250 mL MF59 Receives: Biological: Swine Influenza
Group C	Experimental	15 µg H3N2c unadjuvanted Receives: Biological: Swine Influenza

What is being measured

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

Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Measured: Day 1 through Day 7 after each vaccination
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Measured: Day 1 through Day 7 after each vaccination
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Measured: Day 1 through Day 7 after each vaccination
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Measured: Day 1 through Day 7 after each vaccination
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.
The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.
Measured: Day 1 through Day 366
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Measured: Day 22, Day 43 post vaccination
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
Measured: Day 1, Day 22, Day 43 post vaccination

Secondary outcomes (6)

Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.
Measured: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.
Measured: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.
Measured: Day 183 and Day 366 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.
Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Measured: Day 22, Day 43 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.
Measured: Day 1, Day 22, Day 43 post vaccination
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.
Measured: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1

Timeline

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

May 2013Sep 2014

First posted17 May 2013 (estimated)
Study startMay 2013
Primary completionSep 2014
Study completionSep 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 Prophylaxis of A/H3N2v 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
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 627 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01855945
Sponsor's protocol ID: V129_01
Status last verified: Jan 2016
First submitted: 2 Apr 2013
Last updated: 17 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Johnson C, Hohenboken M, Poling T, Jaehnig P, Kanesa-Thasan N. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study. J Infect Dis. 2015 Jul 1;212(1):72-80. doi: 10.1093/infdis/jiu826. Epub 2014 Dec 23.
PubMed 25538277

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Multi-center, Observer-Blind, Randomized, Dose-Ranging Study of Adjuvanted and Non-Adjuvanted Cell Culture-Derived, Inactivated Novel Swine Origin A/H3N2v Monovalent Subunit Influenza Virus Vaccine (H3N2c) in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to < 65 Years and Elderly ≥ 65 Years and Older.
ClinicalTrials.gov ID: NCT01855945
Acronym / sponsor ID: V129_01
Conditions: Prophylaxis of A/H3N2v Influenza
Keywords: Influenza
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 627 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 17 May 2013 (estimated)
Results: Posted 17 Feb 2016

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: Swine Influenza3.75 µg H3N2c HA + 0.125 mL MF59
Group B	Experimental	Biological: Swine Influenza7.5 µg H3N2c HÁ + 0.250 mL MF59
Group C	Experimental	Biological: Swine Influenza15 µg H3N2c unadjuvanted

Who may qualify

Ages: 3 to 92 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Males and females 3 years of age and older
Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
Individuals who can comply with study procedures and are available for follow-up

Key exclusion criteria (31 listed)

Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest

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
Swine InfluenzaComparison of different dosages of vaccines	Biological	Group A, Group B, Group C

Primary outcome

Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1 through Day 7 after each vaccination
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1 through Day 7 after each vaccination
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1 through Day 7 after each vaccination
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1 through Day 7 after each vaccination
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1 through Day 366
The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 22, Day 43 post vaccination
The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1, Day 22, Day 43 post vaccination
The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.

6 secondary outcomes

Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
Time frame: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 183 and Day 366 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 22, Day 43 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 1, Day 22, Day 43 post vaccination
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
Time frame: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1

Results and safety

Results posted to the registry on 17 Feb 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
A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	54	38
A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	55	44
A/H3N2C Age Group: 3 TO <9 YEARS	51	39
A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS	53	49
A/H3N2C + MF59 Age Group: 9 TO <18 YEARS	51	50
A/H3N2C Age Group: 9 TO <18 YEARS	53	50
A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS	53	43
A/H3N2C + MF59 Age Group: 18 TO <65 YEARS	55	47
A/H3N2C Age Group: 18 TO <65 YEARS	48	46
A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS	51	49
A/H3N2C + MF59 Age Group: ≥65 YEARS	51	46
A/H3N2C Age Group: ≥65 YEARS	52	49

Primary outcome: Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.

Time frame: Day 1 through Day 7 after each vaccination. Number. Unit: Number of Subjects

Measure	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS n = 49	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS n = 53	A/H3N2C - Age Group: 3 TO <9 YEARS n = 49
ANY- Vac. 1	31	36	18
ANY- Vac. 2 (N= 45,52,48)	24	25	22
INJECTION SITE REACTIONS- Vacc. 1	28	33	16
INJECTION SITE REACTIONS- Vacc. 2	22	24	17
ECCHYMOSIS (mm), < 6y (T.II, 1st Vac.,N=14,20,15)	2	0	0
ECCHYMOSIS (mm), < 6y (T.II, 2nd Vac.,N=11,21,16)	1	2	0
ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=33,29,31)	0	0	0
ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=32,31,32)	0	0	0

Population analysed: Analysis was done on Solicited Safety Set.

Primary outcome: Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Time frame: Day 1 through Day 7 after each vaccination. Number. Unit: Number of Subjects

Measure	A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS n = 54	A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS n = 51	A/H3N2C - Age Group: 9 TO <18 YEARS n = 53
ANY- Vac. 1	37	40	35
ANY- Vac. 2 (N=52,48,53)	30	24	27
INJECTION SITE REACTIONS- Vacc. 1	35	34	27
INJECTION SITE REACTIONS- Vacc. 2	24	20	23
ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53)	0	1	0
ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52)	0	1	0
ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53)	0	3	1
ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52)	1	2	1

Population analysed: Analysis was done on Solicited Safety Set.

Primary outcome: Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Time frame: Day 1 through Day 7 after each vaccination. Number. Unit: Number of Subjects

Measure	A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS n = 51	A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS n = 54	A/H3N2C - Age Group: 18 TO <65 YEARS n = 48
ANY- Vac. 1	30	40	27
ANY- Vac. 2 (N=47,51,48)	21	28	21
INJECTION SITE REACTIONS- Vacc. 1	23	32	19
INJECTION SITE REACTIONS- Vacc. 2	17	24	15
ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45)	0	1	0
ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48)	0	0	1
ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47)	0	5	0
ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48)	0	1	0

Population analysed: Analysis was done on Solicited Safety Set.

Primary outcome: Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Time frame: Day 1 through Day 7 after each vaccination. Number. Unit: Number of Subjects

Measure	A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS n = 51	A/H3N2C + MF59 - Age Group: ≥65 YEARS n = 49	A/H3N2C - Age Group: ≥65 YEARS n = 50
ANY- Vac. 1	23	29	15
ANY- Vac. 2 (N=51,45,48)	14	17	14
INJECTION SITE REACTIONS- Vac. 1	11	21	6
INJECTION SITE REACTIONS- Vac. 2	9	14	5
ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50)	2	0	0
ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48)	0	0	1
ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49)	1	1	2
ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48)	1	2	1

Population analysed: Analysis was done on Solicited Safety Set.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 through Day 366.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	0 of 50 (0%)	36 of 50 (72%)	Not reported
A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	1 of 54 (1.9%)	46 of 54 (85.2%)	Not reported
A/H3N2C Age Group: 3 TO <9 YEARS	0 of 50 (0%)	30 of 50 (60%)	Not reported
A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS	0 of 54 (0%)	44 of 54 (81.5%)	Not reported
A/H3N2C + MF59 Age Group: 9 TO <18 YEARS	0 of 51 (0%)	42 of 51 (82.4%)	Not reported
A/H3N2C Age Group: 9 TO <18 YEARS	1 of 53 (1.9%)	45 of 53 (84.9%)	Not reported
A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS	3 of 51 (5.9%)	35 of 51 (68.6%)	Not reported
A/H3N2C + MF59 Age Group: 18 TO <65 YEARS	0 of 54 (0%)	43 of 54 (79.6%)	Not reported
A/H3N2C Age Group: 18 TO <65 YEARS	1 of 48 (2.1%)	30 of 48 (62.5%)	Not reported
A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS	2 of 52 (3.8%)	33 of 52 (63.5%)	Not reported
A/H3N2C + MF59 Age Group: >=65 YEARS	5 of 49 (10.2%)	31 of 49 (63.3%)	Not reported
A/H3N2C Age Group: >=65 YEARS	5 of 51 (9.8%)	32 of 51 (62.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25538277Johnson C, Hohenboken M, Poling T, Jaehnig P, Kanesa-Thasan N. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study. J Infect Dis. 2015 Jul 1;212(1):72-80. doi: 10.1093/infdis/jiu826. Epub 2014 Dec 23.

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Swine Influenza in people with Prophylaxis of A/H3N2v Influenza, run by Novartis Vaccines at 11 sites in United States.

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 31 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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 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.

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 17 Feb 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?

Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine. (time frame: Day 1 through Day 7 after each vaccination). The study lists 7 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 NCT01855945, 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 17 Feb 2016.