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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00996307
First received: October 15, 2009
Last updated: December 7, 2011
Last verified: December 2011
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: MF59-eH1N1_f

  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
Participants were enrolled at 29 sites in USA and Mexico

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects enrolled were included in the trial. The data entered is for the overall study.

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.
15_(0)MF59 15 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   15_(0)MF59
STARTED   164   165   160   165 
COMPLETED   144   148   146   144 
NOT COMPLETED   20   17   14   21 
Adverse Event                0                1                0                0 
Withdrawal by Subject                3                2                5                5 
Lost to Follow-up                13                13                7                15 
Administrative reason                0                1                0                0 
Unable to classify                4                0                2                1 



  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.
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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.
15_(0)MF59 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
Total Total of all reporting groups

Baseline Measures
   3.75_(50)MF59   7.5_(0)MF59   7.5_(50)MF59   15_(0)MF59   Total 
Overall Participants Analyzed 
[Units: Participants]
 164   165   160   165   654 
Age 
[Units: Months]
Mean (Standard Deviation)
         
6 to <36 Months age   21.2  (7.9)   21.6  (8.8)   21.1  (8.4)   21.3  (8.9)   21.3  (8.5) 
Gender 
[Units: Participants]
         
Female   75   79   80   78   312 
Male   89   86   80   87   342 


  Outcome Measures
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1.  Primary:   Antibody Responses After the First and Second Vaccinations   [ Time Frame: 21 days after each vaccination ]

2.  Primary:   Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination   [ Time Frame: Day 1 to 7 ]

3.  Primary:   Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination   [ Time Frame: Day 22 to 28 ]

4.  Secondary:   Immunogenicity Measurement by Geometric Mean Titers (GMT)   [ Time Frame: 21 days after each vaccination ]

5.  Secondary:   Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010   [ Time Frame: Past 12 months ]

6.  Secondary:   Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010   [ Time Frame: Past 12 months ]

7.  Secondary:   Antibody Response Based on Baseline Seropositivity   [ Time Frame: up to Day 43 ]

8.  Secondary:   Geometric Mean Titers (GMTs) Based on Baseline Seropositivity   [ Time Frame: up to Day 43 ]

9.  Secondary:   Antibody Persistence 6 Months and 12 Months After the Second Vaccination   [ Time Frame: 6 months and 12 months after second vaccination ]

10.  Secondary:   Antibody Persistence by Geometric Mean Titers (GMT)   [ Time Frame: 6 months and 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
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  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: RegistryContactVaccinesUS@novartis.com



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00996307     History of Changes
Other Study ID Numbers: V112_06
Study First Received: October 15, 2009
Results First Received: April 28, 2011
Last Updated: December 7, 2011