Safety, Immunogenicity and Compatibility With DTP of a Typhoid Fever Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00342628
First received: June 19, 2006
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: March 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Typhoid Fever
Interventions: Biological: Vi-rEPA conjugate vaccine for typhoid fever
Biological: Hib-TT
Biological: DTP

  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
Informed consent was obtained from expectant women during prenatal visits in Thanh Thuy District, Phu-Tho Province, Vietnam. Mothers and newborns were enrolled during labor at commune/district health centers from July 26, 2006 to March 8, 2007. Only fullterm newborns with birth weights of >=2500 grams were enrolled.

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-rEPA Plus DTP Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
Hib-TT Plus DTP Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
DTP Vaccines DTP at 2, 4, and 6 months of age

Participant Flow:   Overall Study
    Vi-rEPA Plus DTP     Hib-TT Plus DTP     DTP Vaccines  
STARTED     100     101     100  
COMPLETED     80 [1]   80 [2]   81 [3]
NOT COMPLETED     20     21     19  
Withdrawal by Subject                 19                 19                 18  
Death                 1                 1                 0  
moved residence                 0                 1                 1  
[1] 84 completed 4 injections, 4 were lost-to-followup after the 4th injection
[2] 83 completed 4 injections, 3 were lost-to-followup after 4th injection
[3] 97 completed 3 injections of DTP alone, 16 were lost-to-followup for blood drawing at 12 months.



  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
Vi-rEPA Plus DTP Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
Hib-TT Plus DTP Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
DTP Vaccines DTP at 2, 4, and 6 months of age
Total Total of all reporting groups

Baseline Measures
    Vi-rEPA Plus DTP     Hib-TT Plus DTP     DTP Vaccines     Total  
Number of Participants  
[units: participants]
  100     101     100     301  
Age, Customized [1]
[units: Days]
Mean ( Full Range )
       
Age at 1st injection     77  
  ( 61 to 92 )  
  76  
  ( 61 to 92 )  
  76  
  ( 61 to 92 )  
  77  
  ( 61 to 92 )  
Age at 2nd injection     137  
  ( 121 to 151 )  
  137  
  ( 120 to 154 )  
  137  
  ( 121 to 151 )  
  137  
  ( 120 to 154 )  
Age at 3rd injection     197  
  ( 181 to 212 )  
  198  
  ( 182 to 211 )  
  197  
  ( 181 to 211 )  
  197  
  ( 181 to 212 )  
Age at 4th injection     382  
  ( 365 to 420 )  
  381  
  ( 365 to 406 )  
  NA  
  ( NA to NA ) [2]
  382  
  ( 365 to 420 )  
Gender  
[units: participants]
       
Female     52     53     46     151  
Male     48     48     54     150  
[1] Study participants are infants recruited at birth, injected with experimental and comparison vaccine at 2, 4, 6 and 12 months of age.
[2] No injection given



  Outcome Measures
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1.  Primary:   Number of Infants With Adverse Reactions After Vaccination   [ Time Frame: at 2, 4, 6 and 12 months ]

2.  Secondary:   IgG Anti-Vi Levels   [ Time Frame: cord sera, infants' sera at 7, 12 and 13 months ]

3.  Secondary:   Antibody Responses to Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Toxin   [ Time Frame: Cord sera, and infants' sera at 7, 12 and 13 months of age ]

4.  Secondary:   Antibody Responses to Hib CP   [ Time Frame: Cord sera and infant sera at 7, 12, and 13 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Feng-Ying (Kimi) Lin, MD, MPH
Organization: PDMI, NICHD, NIH
phone: 301-496-0295
e-mail: link@mail.nih.gov


Publications:


Responsible Party: National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier: NCT00342628     History of Changes
Other Study ID Numbers: 999999050, OH99-CH-N050
Study First Received: June 19, 2006
Results First Received: March 30, 2012
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration