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Submitted by: Mrs. Nina Dalisay Bauzon 2020-01-14 05:30:41 Last Updated by: Mrs. Nina Dalisay Bauzon 2021-03-17 08:46:28


A Phase II/III, Multicenter, Observer- Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typar- TCV ® in Healthy 6 Months – 45 Years Aged Participants

PHRR200116-002414

EuVCT-TCV301

2019-CT0512

A Phase II/III, Multicenter, Observer- Blinded, Randomized, Non-inferiority and Safety Study of Typhoid Conjugate Vaccine (EuTCV) Compared to Typar- TCV ® in Healthy 6 Months – 45 Years Aged Participants

This is an observer-blinded, comparative, single dose, multicenter, clinical Phase II/III study to assess the immunogenicity and safety of EuVCT compared to Typhoid conjugate vaccine (Typbar-TCV®, Bharat Biotech) in healthy Filipino participant aged 6 months to 45 years.
A total of 440 healthy participants will be randomly assigned in ratio of 1:1:1:1 into 4 treatment arms. An equal number of participants are planned to be enrolled from 3 age groups: ≥2 and Participants aged ≥2 and ≤45 years will be enrolled and vaccinated first. Participants aged ≥6 months and During the study, participants will be monitored specifically for immunogenicity (GMT and seroconversion rates 4 weeks after vaccination), local adverse reactions (pain, tenderness, erythema, redness, swelling, induration and pruritis associated with injection) and systemic reactions (fever [>38℃], lethargy, irritability, nausea/vomiting, arthralgia, diarrhea, drowsiness, loss of appetite, chills headache, fatigue, myalgia, persistent crying and acute allergic reaction). Participants will be questioned for well-being at the time of clinical examinations and vital signs will be recorded. Laboratory assessments of hematology, biochemistry and urinalysis will be done at Visits 1, 2 and 4. Any abnormality in laboratory results will be evaluated for clinical relevance, and clinically relevant abnormal value will be treated as an AE. Sera sample will be collected pre-vaccination (Day -3 to -1; Visit 1) & post-vaccination (Day 28; Visit 4) to determine anti-Vi IgG antibody response as primary outcome of study and safety assessment as secondary outcome of study. Serious Adverse Events (SAEs) and AE will be assessed by follow-up at Visit 5 (Day 168 [+14 days]) and study will be terminated.

Start Date Duration in Months Target Completion Date Actual Completion Date
2020-03-01 18 2021-09-01 2021-09-01

Ongoing

Institution Classification Region LTO #
Eubiologics Co. Ltd Private Business South Korea N/A
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR 3000002140826
Institution Region
Eubiologics Co. Ltd South Korea
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano Jenny.arellano@novotech-cro.com Unit A & D, 5th Floor, Rockwell Business Tower 1, Rockwell Business Center, Ortigas Avenue, Baranggay Ugong, Pasig Metro Manila 1604 Philippines
Name E-Mail Institution and Institution Address
Youngjin Lee yjlee@eubiologics.com 6F Mabang -ro 8, Seocho-gu Seoul 06778
Name Expertise Affiliation
Grace Devota G. Go, MD Pedia-Infectious Disease Mary Chiles General Hospital
Loreta Baldovino Zoleta-de Jesus, MD Infectious Disease Adult De La Salle Angelo King Medical Research Center
Project Location Institutional Ethics Review Board
Mary Chiles General Hospital Mary Chiles General Hospital Ethics Review Committee
De La Salle Angelo King Medical Research Center N/A

Healthy Individuals

Primary Endpoints
 Primary Immunogenicity assessed as follows:
1. Seroconversion* rate: 4 weeks after vaccination of EuTCV (pooled of 3 batches)/ Typbar-TCV® compared to baseline

*seroconversion is defined as a 4-fold increase of serum anti-Vi IgG antibody titer from baseline


 Safety assessed as follows:
1. Proportion of Solicited local and systemic AEs 7 days after vaccination
2. Proportion of unsolicited AEs within 28 days after vaccination

 

The following safety endpoints are of primary interest:


o Proportion of local and systemic solicited AEs during the first 7 days after the vaccination

o Solicited local reactions at the site of injection: pain, tenderness, erythema/redness, swelling/ induration, pruritus

o Solicited Systemic reactions (adapted to each age group): fever, lethargy, irritability, nausea/vomiting, arthralgia, diarrhea, drowsiness, loss of appetite, chills headache, fatigue, myalgia, persistent crying and acute allergic reaction.

o Proportion of unsolicited AEs during the 4 weeks (28 days) post-vaccination
o Proportion of unsolicited AEs within 168 days post-vaccination
o Proportion of Serious Adverse Events during the entire study period.


Treatment-emergent adverse events (TEAEs), SAE, treatment-related TEAEs and TEAEs leading to study withdrawal will be summarized by MedDRA system organ class (SOC) terms and preferred terms (PTs). Summaries by SOC, PT and severity grading and causality will also be presented. Separate outputs will be produced for events starting with 7 days after the vaccination and for all events overall. Solicited and unsolicited events will be presented separately.


o Other safety data including, physical examination, vital signs and safety laboratory data will be summarized and listed.

Secondary Endpoints
 Secondary Immunogenicity assessed as follows:
1. GMT following 4 weeks after vaccination of EuTCV (pooled of 3 batches)/ Typbar-TCV®
2. Seroconversion rates (4 weeks after vaccination of 3  batches of EuTCV)
3. Seroconversion rates (4 weeks after vaccination by age strata)
4. GMT: 4 weeks after vaccination of EuTCV (3 batches)

Exploratory Endpoints
 Exploratory Immunogenicity assessed as follows:
1. GMT following 4 weeks after vaccination of EuTCV (pooled of 3 batches)/ Typbar-TCV® by age strata
 Safety assessed as follows:
1. Proportion of unsolicited AEs within 168 days post vaccination
2. Serious adverse events (SAEs) at visit 5

Completed

  • Philippines

Clinical Trial

EuVCT-TCV301

2019-CT0512

2019-11-25

0000-00-00

444

444

Unspecified

01 Mar 2020

Inclusion criteria
A participant will be eligible for study participation if all the following criteria are met:
1. Healthy participants ≥6 months and ≤45 years of age at enrolment
2. Participants/Parents/Legally Authorized Representative (LAR) willing to give written informed consent/assent to participate in the trial
3. Participants/Parents/LAR willing to follow the study procedures of the study and available for the entire duration of the study
4. Participants who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests
5. Female participants must have a negative serum (at Screening) and negative urinary (at Day 1) pregnancy test and agree to use 2 methods of contraception (as below) from dosing until 90 days after vaccination.
Adequate contraception allowed in this trial is defined as follows:
A highly effective method of birth control for pre menopausal female participants and pre-menopausal female partners of male participants, including at least one of the following
a. Blockage methods – vaginal diaphragm for contraception, vaginal sponges or cervical cap (where available)
b. Intrauterine devices or the implantation of intrauterine system
c. Sterilization surgery such as tubal ligation in females at least 6 months prior to screening
In addition, sexual abstinence for the entire duration of risk (from the date of vaccination until 90 days after vaccination) is acceptable if this is consistent with the usual and preferred lifestyle of the participant.

Exclusion Criteria

A Participant will be ineligible for study participation if any of the following criteria are met:
1. Participants/Parents/LAR unwilling to give his/her consent/assent to participate in the trial
2. Participants concomitantly enrolled or scheduled to be enrolled in another trial

3. Children and infants with a congenital abnormality
4. Known history of immune function disorders including immunodeficiency disease, or 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
5. Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
6. History of uncontrolled coagulopathy or blood disorders
7. 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 trial objectives
8. Known history of administration of blood or blood derived products in the past 90 days before Screening
9. Participants with a previously ascertained or suspected disease caused by S. Typhi (confirmed either clinically, serologically or microbiologically)
10. Participants who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi
11. Participants who have received the last dose of Typhoid containing vaccines less than 10 years back
12. Participants already immunized with any licensed vaccine within 4 weeks prior to enrolment/vaccination (Day 1) or planned to receive any vaccine within 4 weeks (except a measles containing vaccine as per government vaccination campaign)
13. Participants who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
14. Participants with known hypersensitivity to any component of the study vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances
15. Acute illness, infectious disease or fever (axillary temperature ≥37.5°C), within three days and/or acute illness requiring systemic antibiotic or antiviral therapy within past 7 days prior to Screening and vaccination should be excluded. However, these participants could be rescreened upon resolution of such conditions.
16. Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
17. Participants who have participated in other trials 90 days prior to enrolment
18. History of alcohol or substance abuse

Observational

Unspecified

Unspecified

None

Randomized

Double Blind

Unspecified

Single

The main purpose of this study is to evaluate the safety and tolerability of a single-dose regimen of a Vi-CRM197 conjugate, EuTCV, in comparison to the WHO prequalified TCV (Typbar-TCV®, Bharat Biotech), in healthy volunteers aged 6 months to 45 years.
This study will be conducted across 4 treatment arms where participants will be randomly assigned in a 1:1:1:1 ratio to receive a single dose of 3 batches of test or comparator vaccine. An independent Data and Safety Monitoring Board (DSMB) assessment will determine if the study will move along from participants aged ≥2 - ≤45 years to participants aged ≥6 months to

Phase II/III

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