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Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MF59-eH1N1_f
MF59-eH1N1_f
MF59-eH1N1_f
MF59-eH1N1_f
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Swine Flu, Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months

Exclusion Criteria:

  • History of serious disease.
  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
  • Known or suspected impairment/alteration of immune function.
  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination

For additional entry criteria, please refer to protocol

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

3.75_(50)MF59

7.5_(0)MF59

7.5_(50)MF59

15_(0)MF59

Arm Description

3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

Outcomes

Primary Outcome Measures

Antibody Responses After the First and Second Vaccinations
CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.

Secondary Outcome Measures

Immunogenicity Measurement by Geometric Mean Titers (GMT)
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
Antibody Persistence by Geometric Mean Titers (GMT)
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.

Full Information

First Posted
October 15, 2009
Last Updated
April 19, 2017
Sponsor
Novartis Vaccines
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00996307
Brief Title
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Official Title
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Swine Flu, Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.75_(50)MF59
Arm Type
Experimental
Arm Description
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Arm Title
7.5_(0)MF59
Arm Type
Experimental
Arm Description
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Arm Title
7.5_(50)MF59
Arm Type
Experimental
Arm Description
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Arm Title
15_(0)MF59
Arm Type
Experimental
Arm Description
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
Primary Outcome Measure Information:
Title
Antibody Responses After the First and Second Vaccinations
Description
CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Time Frame
21 days after each vaccination
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Description
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Time Frame
Day 1 to 7
Title
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Description
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Time Frame
Day 22 to 28
Secondary Outcome Measure Information:
Title
Immunogenicity Measurement by Geometric Mean Titers (GMT)
Description
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
Time Frame
21 days after each vaccination
Title
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Description
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Time Frame
Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Title
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Description
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Time Frame
Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Title
Antibody Response Based on Baseline Seropositivity
Description
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
Time Frame
Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Title
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Description
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
Time Frame
Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Title
Antibody Persistence by Geometric Mean Titers (GMT)
Description
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Time Frame
6 months (Day 202) and 12 months (Day 387) after second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months Exclusion Criteria: History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function. Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination For additional entry criteria, please refer to protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
City
Canoga Park
State/Province
California
ZIP/Postal Code
91306
Country
United States
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37087
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
City
Delegacion Tlalpan
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

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