Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01229176
First received: October 25, 2010
Last updated: April 11, 2014
Last verified: April 2014
Results First Received: March 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Typhoid Fever
Interventions: Biological: Vi-CRM197 vaccine
Biological: Vi Polysaccharide (PS) vaccine
Biological: Pneumococcal conjugate 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
No text entered.

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
Vi-CRM, Adults Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Vi-PS, Adults Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
Vi-CRM, Children Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-PS, Children Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Vi-CRM, Older Infants Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
PNC13, Older Infants Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Vi-CRM, Infants Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
PNC13, Infants Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine

Participant Flow:   Overall Study
    Vi-CRM, Adults     Vi-PS, Adults     Vi-CRM, Children     Vi-PS, Children     Vi-CRM, Older Infants     PNC13, Older Infants     Vi-CRM, Infants     PNC13, Infants  
STARTED     40     40     20     20     20     20     20     20  
COMPLETED     40     37     20     19     18     18     20     17  
NOT COMPLETED     0     3     0     1     2     2     0     3  
Withdrawal by Subject                 0                 0                 0                 1                 1                 1                 0                 1  
Lost to Follow-up                 0                 3                 0                 0                 1                 1                 0                 2  



  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.
All enrolled Set

Reporting Groups
  Description
Vi-CRM, Adults Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
Vi-PS, Adults Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
Vi-CRM, Children Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
Vi-PS, Children Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
Vi-CRM, Older Infants Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
PNC13, Older Infants Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
Vi-CRM, Infants Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
PNC13, Infants Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
Total Total of all reporting groups

Baseline Measures
    Vi-CRM, Adults     Vi-PS, Adults     Vi-CRM, Children     Vi-PS, Children     Vi-CRM, Older Infants     PNC13, Older Infants     Vi-CRM, Infants     PNC13, Infants     Total  
Number of Participants  
[units: participants]
  40     40     20     20     20     20     20     20     200  
Age, Customized  
[units: participants]
                 
6 weeks to 8 weeks (infants)     0     0     0     0     0     0     20     20     40  
9 months to 12 months (older infants)     0     0     0     0     20     20     0     0     40  
24 months 59 months (children)     0     0     20     20     0     0     0     0     40  
18 years to 45 years (adults)     40     40     0     0     0     0     0     0     80  
Gender  
[units: participants]
                 
Female     18     17     11     9     12     12     10     8     97  
Male     22     23     9     11     8     8     10     12     103  
Race (NIH/OMB)  
[units: participants]
                 
American Indian or Alaska Native     0     0     0     0     0     0     0     0     0  
Asian     40     40     20     20     20     20     20     20     200  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0     0     0  
Black or African American     0     0     0     0     0     0     0     0     0  
White     0     0     0     0     0     0     0     0     0  
More than one race     0     0     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
                 
Pakistan     20     20     20     20     20     20     20     20     160  
India     20     20     0     0     0     0     0     0     40  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer   [ Time Frame: At 28 days after last vaccination as compared to baseline ]

2.  Primary:   Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer   [ Time Frame: At 6 months after last vaccination as compared to baseline ]

3.  Primary:   Anti-Vi ELISA Geometric Mean Concentration (GMC)   [ Time Frame: At 28 days after last vaccination ]

4.  Primary:   Anti-Vi ELISA GMC   [ Time Frame: At 6 months after last vaccination ]

5.  Secondary:   Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination   [ Time Frame: During the 7-day follow-up period after 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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Audino Podda
Organization: Novartis Vaccines Institute for Global Health
phone: +39 0577 243496
e-mail: audino.podda@novartis.com


Publications of Results:

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01229176     History of Changes
Other Study ID Numbers: H01_02TP
Study First Received: October 25, 2010
Results First Received: March 5, 2014
Last Updated: April 11, 2014
Health Authority: Pakistan: Ministry of Health
India: Drugs Controller General of India