CTRI/2015/05/005768 [Registered on: 13/05/2015] 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 compare immune response and safety of DPT vaccine of Cadila Healthcare Ltd. with DPT vaccine of Serum Institute of India Ltd. in healthy children
Scientific Title of Study
A prospective, randomized, two-arm, single-blind, parallel, active-controlled, multicentre,
non-inferiority, phase II/III clinical study to evaluate the immunogenicity and safety of
Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Limited compared to Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) of M/s Serum Institute of India Limited in healthy infants
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
14-06; Version No. 00; Dated 11/07/2014
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Andhra Medical College & King George Hospital, Visakhapatnam
Pediatric ward, Unit-III, 1st floor, Department of Pediatrics, Andhra Medical College & King George Hospital, Maharanipeta Visakhapatnam ANDHRA PRADESH
09848337511
domathotirg@gmail.com
Dr T Ramesh Babu
Gandhi Hospital, Secunderabad
Study room, 1st floor, main building, Department of Pediatrics, Gandhi Hospital, Musheerabad, Secunderabad Hyderabad ANDHRA PRADESH
09247119597
ramesh_ped@yahoo.com
Dr Himanshu Arvind Joshi
GMERS Medical College & Civil Hospital, Ahmedabad
Room No. 34, Transit OPD, 1st floor, Department of Pediatrics,
Civil Hospital, Sola, S.G. Highway, Near New Gujarat High Court Ahmadabad GUJARAT
09825014937
drhimanshujoshi60@gmail.com
Dr Rajib Kumar Ray
Hi-Tech Medical College and Hospital, Bhubaneswar
Department of Pediatrics, Hi-Tech Medical College and Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar Khordha ORISSA
09338089618
drrajib2007@gmail.com
Dr Jaydeep Choudhury
Institute of Child Health, Kolkata
Room No. 113, Ground floor, Institute of Child Health, 11, Dr. Biresh Guha Street Kolkata WEST BENGAL
09831191020
drjaydeep_choudhury@yahoo.co.in
Dr Sonali Kar
Kalinga Institute of Medical Sciences, Bhubaneswar
Department of Community Medicine, Kalinga Institute of Medical Sciences, KIIT campus - 5, Patia, Bhubaneswar Khordha ORISSA
9438423273
sonsam72@yahoo.co.uk
Dr Sciddhartha Koonwar
King George’s Medical University, Lucknow
Room No. 401, 3rd floor, Department of Pediatrics, King George’s Medical University Lucknow UTTAR PRADESH
09415102691
dr_sciddhartha@yahoo.com
Dr Mamta Vijay Manglani
Lokmanya Tilak Municipal Medical College & General Hospital, Mumbai
OPD No. 7 (Pediatrics OPD),1st floor, Department of Pediatrics, Lokmanya Tilak Municipal Medical College & General Hospital, Sion Mumbai MAHARASHTRA
Ethics Committee - Institute of Child Health, 11, Dr. Biresh Guha Street, Kolkata – 700017
Approved
Ethics Committee, GMERS Medical College Sola, S.G. Highway, Near New Gujarat High Court, Ahmedabad-380061, Gujarat
Approved
Institutional Ethics Committee – Gandhi Medical College / Hospital, Musheerabad, Secunderabad – 500003
Approved
Institutional Ethics Committee, Hi-Tech Medical College & Hospital, Health Park, Pandara, Rasulgarh, Bhubaneswar
Approved
Institutional Ethics Committee, Kalinga Institute of Medical Sciences, KIIT Campus – 5, Bhubaneswar, Orissa
Approved
Institutional Ethics Committee, King George Hospital, Visakhapatnam - 530002, Andhra Pradesh
Approved
Institutional Ethics Committee, King George’s Medical College, Office of Research Cell, Administrative Block, King George’s Medical University, Lucknow, Uttar Pradesh
Approved
Institutional Ethics Committee, Lokmanya Tilak Municipal Medical College (IEC-HR-LTMMC), Staff and Research Society, L.T.M. Medical College Building, Sion, Mumbai - 400 022
Primary immunization against Diphtheria, Tetanus & Pertussis
Patients
(1) ICD-10 Condition: Z23||Encounter for immunization,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) of M/s Cadila Healthcare Ltd.
Subject will receive three doses (0.5 ml each) of Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed) administered as intramuscular injection in the anterolateral aspect of the upper thigh with 28 days interval between successive doses. The subject will receive a total of 3 doses of test vaccine & will be followed up till 28 days after the last dose of vaccine
Comparator Agent
Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) of M/s Serum Institute of India Ltd.
Subject will receive three doses (0.5 ml each) of Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) administered as intramuscular injection in the anterolateral aspect of the upper thigh with 28 days interval between successive doses. The subject will receive a total of 3 doses of reference vaccine & will be followed up till 28 days after the last dose of vaccine
Inclusion Criteria
Age From
42.00 Day(s)
Age To
56.00 Day(s)
Gender
Both
Details
1. Healthy infant of either gender between 6-8 weeks of age (i.e. 42 to 56 days of age, both days inclusive) at the time of enrollment
2. Subject born after a normal gestational period of 37-42 weeks with birth weight ≥ 2.5 Kg
3. Body weight ≥ 3.3 Kg at the time of enrollment
4. Subject in a good clinical condition as judged by the investigator based on medical history and physical examination
5. Written informed consent obtained from the subject’s parents or legally acceptable representative
6. Subject’s parents or legally acceptable representative literate enough to fill the diary card
ExclusionCriteria
Details
1. Any vaccination before enrollment except vaccination with BCG vaccine, Hepatitis-B vaccine and oral polio vaccine
2. Past history of diphtheria, pertussis or tetanus
3. History of known or suspected allergy to any of the vaccine components
4. History of thrombocytopenia or any coagulation disorder, or subject on anticoagulation therapy
5. Subject with any clinically significant congenital disorder, immunodeficiency disorder and subject on any immunosuppressive or immunostimulant therapy
6. Subject with history of clinically significant systemic disorder especially neurological disorder
7. Known personal or maternal history of HIV, Hepatitis-B (HBsAg) or Hepatitis-C seropositivity
8. History of any acute illness within the past 1 week
9. Subject with febrile illness (axillary temperature ≥ 37.5 0C) at the time of enrollment
10. Planned or elective surgery during the course of the study
11. History of administration of blood, any blood containing product or immunoglobulins since birth
12. Participation of subject in any clinical trial since birth or participation of subject’s mother in any clinical trial within the past 30 days
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
Proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at day 84
28 days following last vaccination (day 84
Secondary Outcome
Outcome
TimePoints
Geometric mean titre of anti-diphtheria, anti-tetanus and anti-pertussis antibodies at baseline and at day 84
28 days following last vaccination (day 84)
Target Sample Size
Total Sample Size="282" Sample Size from India="282" Final Enrollment numbers achieved (Total)= "288" Final Enrollment numbers achieved (India)="288"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomized, single blind, parallel, active controlled, non-inferiority, multicentre clinical trial to evaluate and compare the immunogenicity and safety of DPT vaccine of M/s Cadila Healthcare Ltd. with DPT vaccine of M/s Serum Institute of India Ltd. in healthy infants. Blood samples will be collected pre-vaccination (day 0) & at 28 days after last vaccination (day 84) to determine anti-diphtheria, anti-tetanus and anti-pertussis antibody titres. The primary objective of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for proportion of subjects with sero-protective levels of anti-diphtheria, anti-tetanus and anti-pertussis antibodies post-vaccination. The sero-protective cut-off titre for serum anti-diphtheria & anti-tetanus antibodies is 0.1 IU/ml. The sero-protective cut-off titre considered for serum anti-pertussis antibodies is 22 U/ml. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study.