Clinical trial NCT01776554: Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Official title: A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Pediatric Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pandemic H5N1 Influenza
Keywords: Influenza, Pandemic, H5N1, Children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2013-01-28
Enrollment: 662
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.


Eligibility criteria: Inclusion Criteria:

1. Healthy pediatric subjects 6 months to 17 years of age,
2. Individuals' parent(s) or legal guardian(s) willing to provide written informed consent,
3. Individuals in good health,
4. Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
5. Individuals willing to provide informed assent (where applicable).

Exclusion Criteria:

1. Individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures,
2. History of any significant illness,
3. History of any chronic medical condition or progressive disease,
4. Presence of medically significant cancer,
5. Known or suspected impairment/alteration of immune function,
6. Presence of any progressive or severe neurologic disorder,
7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
8. History of allergy to vaccine components,
9. Receipt of any other investigational product within 30 days prior to entry into the study,
10. History of previous H5N1 vaccination,
11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
12. Receipt of any other vaccine within 2 weeks prior to entry into the study,
13. Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Pregnant or breast feeding,
15. Females of childbearing potential refusing to use acceptable method of birth control,
16. Body mass index (BMI) ≥ 35 kg/m2,
17. History of drug or alcohol abuse,
18. Any planned surgery during study period,
19. Individuals conducting the study and their immediate family members,
20. Individuals with behavioral or cognitive impairment or psychiatric diseases,
21. Individuals diagnosed with any growth disorders.

Primary outcomes:
measure: The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Three weeks after 2nd vaccination (day 43)
measure: Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination
timeFrame: From day 1 through day 7 after each vaccination.
measure: Number of Subjects (≥6 Years - 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination
timeFrame: From day 1 through day 7 after any vaccination.
measure: Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination
timeFrame: Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387
Secondary outcomes:
measure: Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.
timeFrame: Day 1, day 22, day 43 and day 387
measure: Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.
timeFrame: Day 1, day 22, day 43 and day 387
measure: Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.
timeFrame: Day 1, day 22, day 43 and day 387
measure: Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain
timeFrame: Day 1, day 22, day 43 and day 387.
measure: Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain
timeFrame: Day 1, day 22, day 43 and day 387.
measure: Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain
timeFrame: Day 1, day 22, day 43 and day 387.
measure: The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Day 22, day 43 and day 387
measure: The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Day 22, day 43 and day 387
measure: The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain
timeFrame: Day 22, day 43 and day 387
Other outcomes:
Locations:
city: Miami
country: United States
facility: 3 Meridian Clinical Research
state: Florida
city: Newton
country: United States
facility: 7 Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: 5 Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: 9 Heartland Research Associates
state: Kansas
city: Saint Louis
country: United States
facility: 1 Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: 6 Meridian Clinical Research
state: Nebraska
city: Georgetown
country: United States
facility: 10 Tekton Research
state: Texas
city: Salt Lake City
country: United States
facility: 8 Foothill Family Clinic
state: Utah
city: South Cottonwood Heights
country: United States
facility: 4 Foothill Family Clinic
state: Utah
city: Spokane
country: United States
facility: 2 Rockwood Clinic P S
state: Washington
city: Bangkok
country: Thailand
facility: 75 Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: 76 Faculty of Tropical Medicine Mahidol University
Study officials:
affiliation: Novartis Vaccines
name: Novartis vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: Chanthavanich P, Versage E, Van Twuijver E, Hohenboken M. Antibody responses against heterologous A/H5N1 strains for an MF59-adjuvanted cell culture-derived A/H5N1 (aH5N1c) influenza vaccine in healthy pediatric subjects. Vaccine. 2021 Nov 16;39(47):6930-6935. doi: 10.1016/j.vaccine.2021.10.010. Epub 2021 Oct 25.
citation: Chanthavanich P, Anderson E, Kerdpanich P, Bulitta M, Kanesa-Thasan N, Hohenboken M. Safety, Tolerability and Immunogenicity of an MF59-adjuvanted, Cell Culture-derived, A/H5N1, Subunit Influenza Virus Vaccine: Results From a Dose-finding Clinical Trial in Healthy Pediatric Subjects. Pediatr Infect Dis J. 2019 Jul;38(7):757-764. doi: 10.1097/INF.0000000000002345.