CTRI/2016/05/006975 [Registered on: 31/05/2016] Trial Registered Prospectively
Last Modified On:
14/11/2018
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical Study to assess the immune response and safety of typhoid conjugate vaccine of Cadila Healthcare Limited and compare it to typhoid conjugate vaccine of Bharat Biotech International Limited in healthy human subjects
Scientific Title of Study
A prospective, randomized, two-arm, parallel, single-blind, active-controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Typhoid Vi
Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s Cadila Healthcare
Limited compared to Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate
Vaccine of M/s Bharat Biotech International Limited in healthy subjects
Trial Acronym
None
Secondary IDs if Any
Secondary ID
Identifier
Project No. 15-03; Version No. 01; Dated 16/01/2016
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Study room, 1st floor,
hospital main building,
Department of
Pediatrics, Gandhi
Hospital, Musheerabad,
Secunderabad - 500003 Hyderabad ANDHRA PRADESH
09247119597
ramesh_ped@yahoo.com
Dr Ambrose Kumar Kandulna
GCS Medical College, Hospital & Research Centre, Ahmedabad
Room No. 13, Medicine OPD, Department of Medicine, GCS Medical College, Hospital & Research Centre, Opp. DRM Office, Near Chamunda Bridge, Naroda Road, Ahmedabad – 380025 Ahmadabad GUJARAT
07698059533
drambrosek@gmail.com
Dr Uma Nayak
GMERS Medical College & General Hospital, Vadodara
Room No. 501, 5th floor, Hospital building, Department of Pediatrics, GMERS Medical College & General Hospital, Gotri, Vadodara 390021 Vadodara GUJARAT
09327214065
umasnayak@gmail.com
Dr Sanjay Kumar Jangid
Hi-Tech Medical College & Hospital, Bhubaneswar
Medicine OPD, Department of Medicine, Hi-Tech Medical College & Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar-751025 Khordha ORISSA
Active immunization for the prevention of typhoid fever caused by Salmonella Typhi bacteria
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s
Cadila Healthcare Limited
Subjects will receive 0.5 ml single dose of Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine administered as intramuscular injection in the deltoid muscle in the upper arm or in the anterolateral aspect of the thigh (for younger children) taking aseptic precautions on day 0. The subjects will be followed up till 42 days post-vaccination
Comparator Agent
Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s Bharat Biotech International Limited
Subjects will receive 0.5 ml single dose of Typhoid Vi Capsular Polysaccharide Tetanus Toxoid Conjugate Vaccine administered as intramuscular injection in the deltoid muscle in the upper arm or in the anterolateral aspect of the thigh (for younger children) taking aseptic precautions on day 0. The subjects will be followed up till 42 days post-vaccination
Inclusion Criteria
Age From
6.00 Month(s)
Age To
45.00 Year(s)
Gender
Both
Details
1. Healthy subjects of either gender between 6 months to 45 years of age
2. Informed consent from adult subjects or from subject’s legally acceptable representative for non-adult subjects. Additionally, assent from non-adult subjects of more than 7 years of age
3. Adult subject or legally acceptable representative of non-adult subject literate enough to fill the diary card
ExclusionCriteria
Details
1. History of hypersensitivity reaction to any component of the study vaccines
2. History of typhoid fever or vaccination against typhoid fever within the last three years
3. Fever of any origin or infections of more than 3 days within the past month
4. Subjects with febrile illness (temperature ≥ 37.5 C) at the time of enrollment
5. History of any vaccination within the past 7 days
6. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
7. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
8. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
10. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
11. Participation in another clinical trial in the past 3 months
12. Subjects with history of alcohol or drug abuse in the past one year
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Sero-conversion rate i.e., Proportion of subjects with ≥ 4 fold rise in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline
42 days post-vaccination
Secondary Outcome
Outcome
TimePoints
Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination
42 days post-vaccination
Sero-conversion rate in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline in both age groups
42 days post-vaccination
Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination in subjects in both age groups
42 days post-vaccination
Target Sample Size
Total Sample Size="238" Sample Size from India="238" Final Enrollment numbers achieved (Total)= "240" Final Enrollment numbers achieved (India)="240"
This is a randomized, parallel group, multicentre, non-inferiority phase II/III clinical trial to evaluate the immunogenicity and safety of Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Cadila Healthcare Ltd. (Test vaccine) as compared to Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Bharat Biotech International Ltd. (Reference vaccine) in healthy subjects of 6 months to 45 years of age. There will be two age cohorts in this study; Adult cohort & Pediatric cohort. The enrollment in this study will be sequential in nature wherein the adult subjects (18 to 45 years) will be enrolled prior to the enrollment of pediatric subjects (6 months to 17 years). A minimum of 238 subjects will be enrolled in this study and will receive either study vaccine as per the central computer generated randomization plan. Two blood samples will be collected; once pre-vaccination (on day 0) & another post-vaccination (on day 42) to determine anti-Vi IgG antibody titre through ELISA method. The primary efficacy/immunogenicity endpoint of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for the proportion of subjects with seroconversion (≥ 4 fold rise) for anti-Vi IgG antibodies post-vaccination. In addition, geometric mean titre of anti-Vi IgG antibodies at the baseline and at the end of study will also be calculated for both the study groups. The safety of the study vaccines will be assessed by recording the adverse events occurring during the entire course of the study.