Submitted by: John Michael Dominic Go 2017-10-23 00:00:00 Last Updated by: Jeverly Ann S. Principe 2017-10-30 14:28:41 Export to PDF

A Phase 2 study to assess the safety and immunogenicity of a new typhoid vaccine compared to current typhoid vaccine in healthy Filipino Infants and Toddlers

PHRR171030-001715

IVI T002

2017-CT0421

A Phase II, Randomized, Dose-scheduling, Observer-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of Vi-DT Conjugate Vaccine in 6-23-Month old Healthy Filipino Infants and Toddlers

Randomized, Dose-scheduling, Observer-Blinded, Phase 2 Safety and Immunogenicity study

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2018-01-15 30 2020-07-15 0000-00-00

Pending

Site has not yet been initiated

Institution Classification Region LTO #
International Vaccine Institute Private Business South Korea N/A
Institution Classification Region LTO #
INC Research Pte. Ltd. Private Business NCR LTO-3000001893279
Institution Amount Region
International Vaccine Institute N/A South Korea
Name E-Mail Phone Number Postal Address
Sue Kyoung Jo skjo@ivi.int +82-2- 881 1150 SNU Research Park, 1 Gwannak-ro, Gwanak-gu, Seoul, 151-742 Korea
Name E-Mail Phone Number Postal Address
Samuel Teshome steshome@ivi.int +82-2-881 1380 SNU Research Park, 1 Gwannak-ro, Gwanak-gu, Seoul, 151-742 Korea
Name Expertise Affiliation
Maria Rosario Z. Capeding, MD Pediatrics Research Institute for Tropical Medicine
Project Location Institutional Ethics Review Board
Research Institute for Tropical Medicine Research Institute for Tropical Medicine Institutional Review Board

Typhoid

1.Assess and describe the safety and reactogenicity of Vi-DT 
2.Assess and compare anti-Vi seroconversion rate 4 weeks post dose one [of combined one and two-dose regimens] of Vi-DT to comparator group 
 

1.Assess and compare immunogenicity 4 weeks post dose 2 of the two-dose regimen to comparator group
2.Assess and compare immunogenicity between week 4 (post dose 1) in single dose regimen and week 28 (4 weeks post dose 2) in the two-dose regimen 
3.Assess and describe immunogenicity of the two regimens at week 28, corresponding to 4 weeks post dose 2 of the two-dose regimen and 28 weeks post dose 1 of the single dose regimen 
4.Assess and describe immunogenicity between week 4 (post dose 1) and week 28 (4 weeks post dose 2) in the two-dose regimen 
5.Assess and describe immunogenicity between week 24 (dose 2) and week 28 (4 weeks post dose 2) of the two-dose regimen 
6.Assess and describe immunogenicity at week 60 in single dose and two dose regimen 
7.Assess and describe immunogenicity between boost time point (week 96) and 4 weeks post boost (week 100) in the single dose regimen. 
8.Assess and describe immunogenicity between week 96 in the single dose regimen comparatively to the two-dose regimen. 
 

Pending

  • Philippines

Clinical Trial

20170731162712

2017-10-11

None

Inclusion Criteria:
 
1.Healthy infants and children 6-23 months of age at enrollment as determined by medical history, physical examination and clinical jugment of the investigator 
2.Birth weight greater than or equal to 2500 gm 
3.Greater than or equal to 37 weeks of pregnancy or judge to be full-term by the midwife or birth attendant 
4.Parents aged 18 years and above and legal guardians aged 21 years and above as per the legal authorization in the Philippines, who have voluntarily given informed consent 
5.Parents/ legal guardians willing to follow the study procedures of the study and available for the entire duration of the study 
 
Exclusion Criteria:
 
1.Child with a congenital abnormality 
2.Subject with abnormal routine biological values at screening 
3.Subject concomitantly enrolled or scheduled to be enrolled in another trial 
4.Acute illness, in particular infectious disease or fever (axillary temperature greater than or equal to 37.5°C), within three days prior to enrolment and vaccination 
5.Known history of immune function disorders including immunodeficiency diseases, or chronic use of systemic steroids (>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs 
6.Child with a previously ascertained or suspected disease caused by S. typhi 
7.Child who have had household contact with/and or intimate exposure to an individual with laboratory-confirmed S. typhi 
8.Known history or allergy to vaccines or other medications 
9.Know history of allergy to eggs, chicken protein, neomycin and formaldehyde 
10.History of uncontrolled coagulopathy or blood disorders 
11.Mother has known HIV infection or other immune function disorders 
12.Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the subject and interfere with the assessment of the study objectives 
13.Child whose parents or legal guardian planning to move from the study area before the end of study period 

Interventional

Vi-DT Conjugate Vaccine

Administered via injection

Randomized

Single Blind

The randomization list will be generated by a independent statistician who is not part of the study at IVI. Upon enrolment, in order to receive the study vaccine, participants will be sent to the vaccine administrator with their randomization number. The unblinded study nurse located in a different room will administer vaccine(s) to the participant according to the randomization list. The randomization number of the participant receiving the study vaccine will be written on the empty vaccine vial, for record and reconcilliation and on the vaccine accountability log. Trial staff other than the unblinded study staff will remain blinded to vaccine administration. The unblinded study nurse will not be involved in the evaluation of vaccine safety and will not discuss with the investigator and clinical staff about vaccines administered.

Parallel

Purpose of the study is to determine the safety and immunogenicity of Vi-DT in healthy infants and toddlers.

Phase II

285

Unspecified

Unspecified

15 Jan 2018

Utilization Utilization Info
No records found.

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