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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972816
First Posted: September 9, 2009
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Results First Submitted: December 6, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: MF59-eH1N1

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
36 centers in the U.S., of which 34 centers enrolled subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
3.75_(50) MF59 3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
7.5_(0) MF59 7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
7.5_(50)MF59 7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
7.5_(100)MF59 7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
15_(0) MF59 15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
15_(50) MF59 15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
15_(100) MF59 15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
30_(0) MF59 30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Participant Flow:   Overall Study
    3.75_(50) MF59   7.5_(0) MF59   7.5_(50)MF59   7.5_(100)MF59   15_(0) MF59   15_(50) MF59   15_(100) MF59   30_(0) MF59
STARTED   173   169   169   169   169   169   169   170 
COMPLETED   156   158   160   161   157   158   159   161 
NOT COMPLETED   17   11   9   8   12   11   10   9 
Adverse Event                0                0                1                0                0                0                0                0 
Withdrawal by Subject                4                2                1                3                0                1                1                2 
Lost to Follow-up                11                9                7                5                11                10                7                7 
Inappropriate enrolment                0                0                0                0                0                0                2                0 
Unable to classify                2                0                0                0                1                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
3.75_(50)MF59 50% of MF59 with 3.75 µg A/H1N1 antigen
7.5 Without MF59 1 dose of 7.5 µg A/H1N1
7.5_(50)MF59 50% of MF59 with 7.5 µg A/H1N1 antigen
7.5_(100)MF59 100% of MF59 with 7.5 µg A/H1N1 antigen
15 Without MF59 1 dose of 15 µg A/H1N1
15_(50)MF59 50% of MF59 with 15 µg A/H1N1 antigen
15_(100)MF59 100% of MF59 with 15 µg A/H1N1 antigen
30 Without MF59 1 dose of 30 µg A/H1N1
Total Total of all reporting groups

Baseline Measures
   3.75_(50)MF59   7.5 Without MF59   7.5_(50)MF59   7.5_(100)MF59   15 Without MF59   15_(50)MF59   15_(100)MF59   30 Without MF59   Total 
Overall Participants Analyzed 
[Units: Participants]
 173   169   169   169   169   169   169   170   1357 
Age 
[Units: Years]
Mean (Standard Deviation)
 5.6  (1.7)   5.2  (1.7)   5.5  (1.8)   5.9  (1.7)   5.6  (1.7)   5.5  (1.7)   5.5  (1.7)   5.5  (1.7)   5.5  (1.7) 
Gender 
[Units: Participants]
                 
Female   81   88   83   83   79   80   75   83   652 
Male   92   81   86   86   90   89   94   87   705 


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group   [ Time Frame: Day 22, Day 29, Day 43, Day 202 and Day 387 ]

3.  Secondary:   Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.   [ Time Frame: Day 22, Day 29, Day 43 ]

4.  Secondary:   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 ]

5.  Secondary:   Antibody Response Based on Baseline Seropositivity   [ Time Frame: Day 22, Day 29 and Day 43 ]

6.  Secondary:   Geometric Mean Titers (GMTs) Based on Baseline Seropositivity   [ Time Frame: Day 1, Day 22, Day 29, Day 43 ]

7.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination   [ Time Frame: 7 days after first vaccination ]

8.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination   [ Time Frame: 7 days after second vaccination ]

9.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegContactVacUS.nvdit@Novartis.com



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00972816     History of Changes
Other Study ID Numbers: V112_02
First Submitted: September 2, 2009
First Posted: September 9, 2009
Results First Submitted: December 6, 2010
Results First Posted: January 27, 2011
Last Update Posted: April 14, 2016