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CTRI Number  CTRI/2012/03/002490 [Registered on: 13/03/2012] Trial Registered Retrospectively
Last Modified On: 15/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to assess the efficacy and safety of ‘Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed’ administered to healthy infants at 6, 10 and 14 weeks of age. 
Scientific Title of Study   A multicentric, phase III clinical trial to assess the immunogenicity and reactogenicity of ‘Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed’ administered to healthy infants at 6, 10 and 14 weeks of age. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AP Dubey 
Designation  Professor & Head  
Affiliation  Maulana Azad Medical College & LNJP Hosptial, New Delhi 
Address  Dr. AP Dubey Professor & Head Department of Pediatrics Maulana Azad Medical College & LNJP Hospital Bahadur Shah Zafar Marg Delhi

Central
DELHI
110002
India 
Phone  9868604303  
Fax    
Email  apdubey52@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajeev Kumar Pathak 
Designation  Manager Regulatory affairs 
Affiliation  Prosper Channel Life Science India Pvt. Ltd. 
Address  B 244 Sector 7 Palam Extension Dwarka New Delhi India

West
DELHI
110077
India 
Phone  01125089029  
Fax  01125089028  
Email  rrajivpathak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajeev Kumar Pathak 
Designation  Manager Regulatory affairs 
Affiliation  Prosper Channel Life Science India Pvt. Ltd. 
Address  B 244 Sector 7 Palam Extension Dwarka New Delhi India

West
DELHI
110077
India 
Phone  01125089029  
Fax  01125089028  
Email  rrajivpathak@gmail.com  
 
Source of Monetary or Material Support  
Prosper Channel Life Science India Pvt Ltd. 
 
Primary Sponsor  
Name  Prosper Channel Life Science India Pvt Ltd 
Address  B 244 Sector 7 Palam Extension Dwarka New Delhi 110077 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AP Dubey  Department of Pediatrics Maulana Azad Medical College & LNJP Hospital Delhi  Maulana Azad Medical College & LNJP Hospital Bahadur Shah Zafar Marg New Delhi 110002
Central
DELHI 
9968604303

apdubey52@rediffmail.com 
Dr MMA Faridi   Department of Pediatrics University College of Medical Sciences & GTB Hospital Delhi  University College of Medical Sciences & GTB Hospital Dilshad Garden Shahdara Delhi 110095
North East
DELHI 
9868399740

mmafaridi@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Maulana Azad Medical College, Institutional Ethical Committee-Academic Section   Approved 
UCMS & GTB Hospital Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary immunization of healthy infants at 6, 10 and 14 weeks of age against diphtheria, tetanus and pertussis diseases 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine  0.5 ml per dose by deep intramuscular injection to healthy Infants at 6, 10 and 14 weeks of age 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  Healthy infants of 6(+4) weeks of age whose parents/legal guardians give written informed consent prior to the study entry.
Infants not seroprotected by immunization and/or disease (to any of the agents targeted by the DPT/DTPa vaccine) 
 
ExclusionCriteria 
Details  Evolving or changing neurological disorder
History of seizures
Fever 38°C in past 3 days
Acute illness or infection requiring systemic antibiotic therapywithin past 7 days
Previous disease potentially related to any of the agents targeted by the DPT vaccine
Preterms
Impairment of the immune function, or
receiving or having received immunosuppressive
therapy within 1 month prior to study entry till completion
Received any blood or blood products, cytotoxic agents or radiotherapy
History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component
Chronic disease such as cardiac, autoimmune disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives.
Participated in another trial of an investigational agent within 30 days of enrolment
Infants whose families are planning to leave the area of the study site before the end of the study period.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anti-PT, anti-FHA, anti-diphtheria and anti-tetanus antibody concentrations.
Seroprotection status defined as anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/ml.
Seroprotection defined for pertussis will be anti-PT, anti-FHA concentrations ≥ 5 EL.U/ml.
 
one month after a three-dose primary vaccination course.
 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of solicited local adverse events
 
During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination
 
Occurrence of solicited general adverse events   During the 4-day (Days 0, 1, 2, 3) follow up period after vaccination 
Occurrence of unsolicited local and general adverse events   On follow up 
Occurrence of serious adverse events   During entire study 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/09/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is multricentric phase III clinical trial to assess the immunogenicity and reactogenicity of ’Diphtheria, Tetanus and acellular Pertussis combined vaccine Adsorbed’ administered to healthy infants at 6, 10 and 14 weeks of age that will be conducted at 2 centers in India. Primary outcome measures will be assessment of immunogenicity 1 month after the three dose primary vaccination series. The secondary outcome will be occurrence of solicitated and unsolicitated local and general adverse events during the 4 day follow up period after vaccination, during follow up and during entire study period. 
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