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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

Primary Purpose

Novel 2009 Influenza H1N1

Status
Completed
Phase
Phase 3
Locations
Costa Rica
Study Type
Interventional
Intervention
MF59-eH1N1_f
eH1N1_f
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

3 Years - 64 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children, adolescents, and adults 3 to 64 years 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

  • Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

2x7.5adj

7.5adj_1_8

7.5adj_1_22

15_1_22

2x15_1_22

Arm Description

Two doses of MF59 adjuvanted (adj) A/H1N1

MF59 adjuvanted (adj) A/H1N1 on days 1 and 8

MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22

A/H1N1 on study days 1 and 22

Two doses of A/H1N1 (one in each arm) on study days 1 and 22

Outcomes

Primary Outcome Measures

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).

Secondary Outcome Measures

Age Distribution at Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).
HI GMR, in Adults 18 to 64 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.

Full Information

First Posted
September 2, 2009
Last Updated
October 29, 2015
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00973700
Brief Title
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
Official Title
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
784 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2x7.5adj
Arm Type
Experimental
Arm Description
Two doses of MF59 adjuvanted (adj) A/H1N1
Arm Title
7.5adj_1_8
Arm Type
Experimental
Arm Description
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
Arm Title
7.5adj_1_22
Arm Type
Experimental
Arm Description
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
Arm Title
15_1_22
Arm Type
Experimental
Arm Description
A/H1N1 on study days 1 and 22
Arm Title
2x15_1_22
Arm Type
Experimental
Arm Description
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1_f
Intervention Description
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Intervention Type
Biological
Intervention Name(s)
eH1N1_f
Intervention Description
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Primary Outcome Measure Information:
Title
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Description
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time Frame
Day 1 to day 387
Title
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Description
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
Time Frame
Day 1 to day 387
Secondary Outcome Measure Information:
Title
Age Distribution at Baseline
Time Frame
Baseline
Title
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Description
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time Frame
Day 1 to day 387
Title
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Description
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).
Time Frame
Day 1 to day 387
Title
HI GMR, in Adults 18 to 64 Years
Description
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).
Time Frame
Day 1 to day 387
Title
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Description
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).
Time Frame
7 days and 21 days after each vaccination
Title
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Description
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
Time Frame
7 days after each vaccination
Title
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Description
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
Time Frame
7 days after each vaccination
Title
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Description
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.
Time Frame
7 days after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children, adolescents, and adults 3 to 64 years 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
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Director
Facility Information:
Facility Name
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
City
San Jose
Country
Costa Rica

12. IPD Sharing Statement

Citations:
PubMed Identifier
21285531
Citation
Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.
Results Reference
result

Learn more about this trial

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

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