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Submitted by: Pearly Anne Cheng 2019-09-30 11:01:33 Last Updated by: Principe, Jeverly Ann S 2020-01-14 12:42:41


A phase III, multicenter, observer blind, randomized, controlled study to evaluate immuneequivalence of multi-dose formulation against single-dose formulation of Vi-DT Typhoidconjugate vaccine and safety in healthy Filipino participants aged 6 months to 45 years.

PHRR200114-002204

Unspecified

2019-CT0508

A phase III, multicenter, observer blind, randomized, controlled study to evaluate immune
equivalence of multi-dose formulation against single-dose formulation of Vi-DT Typhoid
conjugate vaccine and safety in healthy Filipino participants aged 6 months to 45 years.

This is a multicentre, randomized, observer-blinded, controlled, immune equivalence study of a Multi-Dose (MD) formulation with 2PE preservative of SK bioscience Vi-DT compared to single-dose (SD) formulation without preservatives of SK bioscience Vi=DT in participants (6months to 45 years) including safety population. The vaccine will be administered to 1,500 healthy participants of 6 months to 45 years of age and followed up to 24 weeks after the injection for safety. Adult participants (N=500) will be followed up for immunogenicity at 4 weeks and all participants till 24 weeks for safety post single dose of either MD & SD formulations. 300 healthy participants will be given control vaccine (locally available licensed Meningococcal conjugate vaccine) to check the background safety events.

This study is an additional Phase III study which has been planned in Philippines will provide safety data of Vi-DT in study population along with Nepal Phase III study and will support its WHO PQ process which require at least 3000 subjects’ safety data in a certain population as prerequisite for a particular product.

Start Date Duration in Months Target Completion Date Actual Completion Date
2020-01-13 18 2021-07-13 0000-00-00

Pending

Waiting for EC approvals and for site to initiation

Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Region
International Vaccine Institute South Korea
Name E-Mail Institution and Institution Address
Jennifer Arellano Jenny.arellano@novotech-cro.com (CRO for RA/EC submission and Clinical Operation) 5F KMC, Rockwell Tower 1, IVI T004 Protocol Version 1.0 28JUN2019 Page 3 of 78 Rockwell Business Center, Ortigas Avenue, Pasig City 1604 The Philippines
Name E-Mail Institution and Institution Address
Dr. Arijit Sil arijit.sil@ivi.int SNU Research Park, 1 Gwanak-ro, Gwanak-gu, Seoul, 151-742 Republic of Korea
Name Expertise Affiliation
Anna Ma. Lena Lopez, MD IM National Institutes of Health - University of the Philippines - Manila, Institute of Child Health and Human Development
Charissa Fay C. Borja-Tabora, MD IM Asian Hospital and Medical Center
Edison Reyes Alberto, MD IM Tropical Disease Foundation, Inc.
Josefina B. Cadorna-Carlos, MD IM University of the East Ramon Magsaysay Memorial Medical Center
Project Location Institutional Ethics Review Board
National Institutes of Health - University of the Philippines - Manila, Institute of Child Health and Human Development N/A
Asian Hospital and Medical Center Asian Hospital and Medical Center Institutional Review Board
Tropical Disease Foundation, Inc. Tropical Disease Foundation Institutional Review Board
University of the East Ramon Magsaysay Memorial Medical Center N/A

Healthy Subjects

The primary objective is to demonstrate the equivalence of immunogenicity as measured by anti-Vi IgG GMT titer at 4 weeks after a single dose of MD/SD formulation in adults.

The secondary objective is to demonstrate theequivalence of immunogenicity in terms of seroconversion rates as measured by anti-Vi IgG
ELISA antibody titers, at 4 weeks after a single dose of MD/SD formulation in adults. A descriptive evaluation of safety at 4 and 24 weeks post single dose of (SD/MD/Meningococcalvaccine), will be performed.

Pending

  • Philippines

Clinical Trial

Unspecified

2019-CT0508

2019-09-11

0000-00-00

1800

Unspecified

Unspecified

13 Jan 2020

Inclusion Criteria
In order to be eligible to participate in this study, any individual must meet the following criteria:
1. Healthy participants 6 months to 45 years of age at enrolment
2. Participants/Parents/LAR who have voluntarily given informed consent/assent
3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study

Exclusion: An individual who meets any of the following criteria will be excluded from participation in thisstudy:
1. Child with a congenital abnormality
2. Participant who has already received meningococcal conjugate vaccine.
3. Participants concomitantly enrolled or scheduled to be enrolled in another trial
4. Known history of immune function disorders including immunodeficiency diseases (Known HIV infection or other immune function disorders)
5. Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs
6. Receipt of blood or blood-derived products in the past 3 months
7. Participant with a previously ascertained or suspected disease caused by S. Typhi (confirmed either clinically, serologically or microbiologically)
8. Participant who has had household contact with and/or intimate exposure to an individual with laboratory-confirmed S. Typhi.
9. Individual who has previously received a typhoid vaccine
10. Participant who has received other vaccines from 1 month prior to test vaccination or planned to receive any vaccine within 1 month (except a measles containing vaccine as per government vaccination campaign)
11. Known history or allergy to vaccines or other medications
12. History of uncontrolled coagulopathy or blood disorders
13. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the
study objectives.
14. Any female participant who is lactating, pregnant* or planning for pregnancy during the course of study period.
15. Participants/Parents/LAR planning to move from the study area before the end of study period
16. As per Investigator’s medical judgement individual could be excluded from the study in spite of meeting all inclusion/exclusion criteria mentioned above

Temporary Contraindication
1. Acute illness, in particular infectious disease or fever (axillary temperature ≥37.5°C), within three days prior to enrolment and vaccination.
a. These individual could be rescreened upon resolution of the above said conditions.

Observational

Unspecified

Unspecified

None

Randomized

Double Blind

RANDOMIZATION/MASKING PROCEDURESThe randomization list will be generated by an IVI independent statistician who is not directly involved in the study conduct. Eligible participants will be assigned to receive single dose of Vi- DT test vaccine(either from multidose or singledose formulation) or control vaccine in a (2.5) : (2.5) : 1 ratio i.e. 750, 750 and 300 participants respectively. The randomization list will contain sequential numbers unique to each participant and the block randomization process will be employed to ensure an effective balance between the interventions. Only the independent statistician will have a complete set of randomization lists. The individual site lists will be kept under lock and key by the pharmacy staff at all clinical sites. At the end of the study after unblinding of the participants, the lists will be returned to the statistician. Two types of randomization list, one with randomization number only, and the second with randomization number and vaccine allocation will be prepared. Participants in the study will be randomized into three treatment groups within each age stratum: 6 to less than 24 months, 2 to less than 18 years, and 18 to 45 years. Randomization list “without the vaccine allocation” withnumbers only will be shared with the blinded trial staff, for enrolling the trial participants and assigning them the randomization number. The randomization list “with the vaccine allocation” will be shared with the unblinded vaccine administrator (study nurse/pharmacist). If feasible, a web based randomization system will be provided to each site and in that case paper based randomization list will not be used. 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/pharmacist 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 and on the vaccine accountability log for record and reconciliation. Trial staff other than the unblinded study staff will remain blinded to vaccine administration. The unblinded study nurse/pharmasist will not be involved in the evaluation of vaccine safety and will not discuss with the investigator and clinical staff about vaccines administered.

Single

1) Primary
- Demonstrate the immune equivalence as measured by anti-Vi IgG Geometric Mean Titer (GMT) of multi dose formulation against single dose formulation of Vi-DT (18-45
year age stratum), at 4 weeks after a single dose.
2) Secondary
- Demonstrate the immune equivalence as measured by seroconversion rates of anti-ViIgG antibody titres of multi dose formulation against single dose formulation of Vi-DT
vaccine (18-45 year age stratum) at 4 weeks after a single dose.
- Describe safety profile in all age strata combined (age 6 months - 45 years old) and in each age stratum, at 4 and 24 weeks

Phase II/III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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