Trials Sponsors Conditions Drugs Pricing

Conditions

Prophylaxis of A/H3N2v Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (7)

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.
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.
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.
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.

Secondary Outcomes (6)

Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
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.
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.
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.
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.
Day 1, Day 22, Day 43 post vaccination

Study Arms (3)

Group A

EXPERIMENTAL

3.75 µg H3N2c HA + 0.125 mL MF59

Biological: Swine Influenza

Group B

EXPERIMENTAL

7.5 µg H3N2c HÁ + 0.250 mL MF59

Biological: Swine Influenza

Group C

EXPERIMENTAL

15 µg H3N2c unadjuvanted

Biological: Swine Influenza

Interventions

Swine InfluenzaBiological

Comparison of different dosages of vaccines

Group AGroup BGroup C

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age3 Years - 92 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Novartis Vaccines
Industrylead

Study Sites (11)

51, Northern California Clinical Research Center

Redding, California, 96001, United States

47, Benchmark Research

Sacramento, California, 95822, United States

46, Johnson County Clinical Trials

Lenexa, Kansas, 66213, United States

49, Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

43, Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

41, Benchmark Research

Metairie, Louisiana, 70006, United States

44, Rochester Clinical Research Inc.

Related Publications (1)

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.
PMID: 25538277DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title: Posting Director
Organization: Novartis Vaccines and Diagnostics

Study Officials

Novartis Vaccines and Diagnostics
Novartis Vaccines
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

627 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

May 17, 2013

Study Start

May 2013

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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:
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);
+16 more criteria

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.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (6)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (6)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations