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Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00644059
First received: March 20, 2008
Last updated: October 13, 2014
Last verified: October 2014
Results First Received: October 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Influenza, Human
Interventions: Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

  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 as follows:

In season 2007/08: 28 active sites in Germany (Excluding Site 023); In season 2008/09: 83 active sites+ 1 coordinating site in Germany, 15 sites in Finland; In season 2009/10: 15 sites in Finland, 2 sites in Italy


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
TIV-adj Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
Flu-control Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Non-flu Control Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of Tick-borne encephalitis (TBE) vaccine

Participant Flow:   Overall Study
    TIV-adj     Flu-control     Non-flu Control  
STARTED     2019     1849     1034  
COMPLETED     1895     1726     969  
NOT COMPLETED     124     123     65  
Lost to Follow-up                 37                 34                 16  
Withdrawal by Subject                 52                 60                 30  
Adverse Event                 8                 5                 1  
Inappropriate Enrollment                 1                 3                 0  
Protocol Deviation/violation                 20                 19                 15  
Unable to classify                 6                 2                 3  



  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
TIV-adj Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
Flu-control Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Non-flu Control Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
Total Total of all reporting groups

Baseline Measures
    TIV-adj     Flu-control     Non-flu Control     Total  
Number of Participants  
[units: participants]
  2019     1849     1034     4902  
Age  
[units: Months]
Mean ± Standard Deviation
  31.9  ± 19.8     32.6  ± 20.1     32.2  ± 19.8     32.2  ± 19.9  
Gender  
[units: participants]
       
Female     962     903     484     2349  
Male     1057     946     550     2553  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control   [ Time Frame: 7 days post-vaccination ]

2.  Primary:   Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)   [ Time Frame: 3 weeks after 2nd vaccination ]

3.  Secondary:   Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination   [ Time Frame: 7 days post-vaccination ]

4.  Secondary:   Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination   [ Time Frame: Study day 1 to Study day 181 ]

5.  Secondary:   Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)   [ Time Frame: 3 weeks after 2nd vaccination ]

6.  Secondary:   Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).   [ Time Frame: 3 weeks after 2nd vaccination ]

7.  Secondary:   Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09   [ Time Frame: 3 weeks after 2nd vaccination ]

8.  Secondary:   Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09   [ Time Frame: 3 weeks after 2nd vaccination ]

9.  Secondary:   Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.   [ Time Frame: 3 weeks after 2nd vaccination ]

10.  Secondary:   Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.   [ Time Frame: 3 weeks after 2nd vaccination ]

11.  Secondary:   Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50 and 181 ]

12.  Secondary:   Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50 and 181 ]

13.  Secondary:   Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50, 181 ]

14.  Secondary:   Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50, 181 ]

15.  Secondary:   Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50 , 181 ]

16.  Secondary:   Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50, 181 ]

17.  Secondary:   Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains   [ Time Frame: On study days 1, 29, 50, 181 ]

18.  Secondary:   Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)   [ Time Frame: On study days 1, 29, 50, 181 ]

19.  Secondary:   Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons   [ Time Frame: 7 days post-vaccination ]

20.  Secondary:   Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child   [ Time Frame: 3 weeks after 2nd vaccination ]

21.  Secondary:   Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months   [ Time Frame: 3 weeks after 2nd 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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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


Publications of Results:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00644059     History of Changes
Obsolete Identifiers: NCT01015885
Other Study ID Numbers: V70P5, Eudract number 2007-003786-41
Study First Received: March 20, 2008
Results First Received: October 6, 2011
Last Updated: October 13, 2014
Health Authority: Germany: Paul-Ehrlich-Institut