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
|
|
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
|
|
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. |