Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

March 14, 2016 updated by: Novartis Vaccines

A Pivotal Randomized, Single-Blind, Dose-Finding 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 Pediatric Subjects 3 to < 9 Years of Age

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Tlalpan, Mexico, 14000
        • Instituto Nacional de Ciencias
  • United States
    • California
      • Downey, California, United States, 90241-4982
        • Premier Health Research Center, LLC
      • Madera, California, United States, 93637
        • Madera Family Medical Group
      • Paramount, California, United States, 90723
        • Center for Clinical Trials, LLC
      • Paramount, California, United States, 90723
        • Center for Clincal Trials, LLC
      • West Covina, California, United States, 91790
        • Center for Clinical Trials of San Gabriel
    • Colorado
      • Thornton, Colorado, United States, 80233
        • 1st International Research Centers
    • Georgia
      • Marietta, Georgia, United States, 30062
        • Pediatrics and Adolescent Medicine
      • Woodstock, Georgia, United States, 30189
        • Pediatrics and Adolescent Medicine
    • Illinois
      • Dekalb, Illinois, United States, 60115
        • Northern Illinois Research Associates
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Bluegrass Clinical Research, Inc.
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Heartland Research Associates LLC
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridien Clinical Research
    • Nevada
      • Henderson, Nevada, United States, 89015
        • Clinical Research Center of Nevada
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Capital Pediatrics and Adolescent Ctr.
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • Dr. Senders and Associates, Pediatrics
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Oregon
      • Beaverton, Oregon, United States, 97006
        • The Portland Clinic LLP
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16506
        • Children's Health Care -West
      • Greenville, Pennsylvania, United States, 16125
        • UPMC/Community Medicine (pediatrics)
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Pediatric Physicians Research, Inc.
      • Pittsburgh, Pennsylvania, United States, 15220
        • Pediatric Alliance - Greentree Division (pediatrics)
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Clinical Research
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Service
      • Tomball, Texas, United States, 77375
        • Pediatric Healthcare of NW Houston
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research, Inc./Foothill Family Clinic South
      • Salt Lake City, Utah, United States, 84109
        • J.Lewis Research, Inc./Foothill Family Clinic
    • Virginia
      • Burke, Virginia, United States, 22015
        • Pi-Coor Clinical Research
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University
    • Washington
      • Spokane, Washington, United States, 99202
        • Rockwood Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children 3 to < 9 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3.75_(50)MF59
3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(0) MF59
7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(50) MF59
7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 7.5_(100) MF59
7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(0) MF59
15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(50)MF59
15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 15_(100) MF59
15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Experimental: 30_(0) MF59
30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Biological: MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387

HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.

PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.

PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Day 22, Day 29, Day 43, Day 202 and Day 387

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387

Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.

PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Day 22, Day 29, Day 43, Day 202 and Day 387
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Time Frame: Day 22, Day 29, Day 43
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Day 22, Day 29, Day 43
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time Frame: Day 1, Day 22, Day 29, Day 43

Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines

Subgroups without recent seasonal flu vaccine:

PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.

Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.

PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Day 1, Day 22, Day 29, Day 43
Antibody Response Based on Baseline Seropositivity
Time Frame: Day 22, Day 29 and Day 43

Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.

Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Day 22, Day 29 and Day 43
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Time Frame: Day 1, Day 22, Day 29, Day 43

Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

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).
Day 1, Day 22, Day 29, Day 43
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Time Frame: 7 days after first vaccination
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
7 days after first vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Time Frame: 7 days after second vaccination
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
7 days after second vaccination
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Time Frame: Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V112_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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