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CTRI Number  CTRI/2014/12/005326 [Registered on: 29/12/2014] Trial Registered Prospectively
Last Modified On: 12/08/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   An Open Label, Randomized, Multicenter Study to evaluate and compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine in Healthy Infants. 
Scientific Title of Study   An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine (Easyfour-TT, Panacea Biotec Ltd.) with Quadrovax® (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) in Healthy Infants. 
Trial Acronym  Easyfour-TT 
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/CR/2013/04/CT/EFTT Version Number 02 dated 30-06-14  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalitendu Mohanty  
Designation  GM-Clinical Research  
Affiliation  Panacea Biotec Limited  
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road

South West
DELHI
110044
India 
Phone  01141679000  
Fax  01141578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalitendu Mohanty  
Designation  GM-Clinical Research  
Affiliation  Panacea Biotec Limited  
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road


DELHI
110044
India 
Phone  01141679000  
Fax  01141578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Public Query  
Name  Dr Lalitendu Mohanty  
Designation  GM-Clinical Research  
Affiliation  Panacea Biotec Limited  
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road


DELHI
110044
India 
Phone  01141679000  
Fax  01141578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Source of Monetary or Material Support  
Panacea Biotec Ltd 
 
Primary Sponsor  
Name  Panacea Biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay K Lalwani  Bharti Vidyapeeth Medical College and Hospital  Dept of Pediatrics Bharti Vidyapeeth Medical College and Hospital, Katraj-Dhankawadi, Satara road
Pune
MAHARASHTRA 		 02040555555

sanjaylalwani2007@rediffmail.com 
Dr Tapas Kr Sabui  Calcutta Medical College  Dept. of Pediatrics Calcutta Medical College, 88, College Street
Kolkata
WEST BENGAL 		 9830196110

tsabui@gmail.com 
Dr Venugopal  King George Hospital  Department of Pediatrics, King George Hospital
Visakhapatnam
ANDHRA PRADESH 		 9848027203

venugopal_kgh@yahoo.com 
Dr Ashish Ramchandra Dhongade  Sant Dnyaneshwar Medical Education  Consultant Pediatric,Sadashiv Peth Opp Vijay Talkies Laxmi Road
Pune
MAHARASHTRA 		 9011095436

researchadmin@shaishavclinic.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research, Calcutta Medical College, kolkata  Approved 
Institutional Ethics Committee, Bharti Vidyapeeth Medical College and Hospital  Approved 
Institutional Ethics Committee, King George Medical College, Vizag  Approved 
Sant Dnyaneshwar Medical Education Research Centre Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary immunization against Diphtheria, Pertussis, tetanus and Haemophilus influenzae 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fully liquid Tetravalent (DTwP –Hib) vaccine, Panacea Biotec Ltd  Diphtheria toxoid ≥ 30 IU(20Lf) Tetanus toxoid ≥60 IU (7.5 Lf) Inactivated w-Bordetella pertussis, 12 IOU (≥4 IU) Hib (PRP-TT) 10µg Al 3+ as Aluminium phosphate gel 0.25 mg Thiomersal 0.025 mg Physiological saline q.s to 0.5 ml Dose, Route, and frequency 0.5 ml of the Easyfour-TT vaccine will be administered by deep intramuscular injection in the anterolateral aspect of thigh at day 0, day 28 and day56. 
Comparator Agent  Quadrovax® (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd   Diphtheria Toxoid ≥ 20 Lf to ≤ 30 Lf Tetanus Toxoid ≥ 5 Lf to ≤ 25 Lf B. Pertussis(Whole cell )≥ 4 IU Purified Capsular HIB Polysaccharide (PRP)10 mcg Conjugated to Tetanus Toxoid (carrier protein) 19-33 mcg Dose, Route, and frequency 0.5 ml of the Quadrovax® vaccine will be administered by deep intramuscular injection in the anterolateral aspect of thigh at day 0, day 28 and day56.  
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  1.Infants 6-10 weeks of age, whose parents/LAR are willing to give written informed consent prior to the study entry.
2.Infants with good health as determined by:
•Medical history
•Physical examination
•Clinical judgment of the investigator
3.Judged to be able to attend all scheduled study visits and to comply with trial procedures.
 
 
ExclusionCriteria 
Details  1.Infants weighing more than 3.3 Kg at the time of enrollment.
2.Infants less than 6 weeks or more than 10 weeks of age.
3.Infants having history of immunization with vaccine other than Hep B, IPV or OPV, Pneumococcal, Rotavirus vaccine.
4.Infants with history of infection potentially related to any of the agents targeted by the DPT-Hib vaccine
5.Presence of evolving or changing neurological disorder or Infants with history of seizures before receiving the vaccine. Initiation or continuation of pertussis vaccination should be deferred until an evolving neurological disorder can be excluded.
6.Fever 38o C in past 3 days
7.Any evidence of acute illness or infection within past 7 days.
8.Planned or elective surgery during the course of the study.
9.Infants with a known or suspected impairment of the immune function (congenital or hereditary), or those receiving immunosuppressive therapy, or received immunosuppressive therapy prior to study entry (including systemic or high doses of inhaled corticosteroids) or those who have received a parenteral immunoglobulin preparation.
10.Infants who have received any blood products, cytotoxic agents or radiotherapy.
11.Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
12.Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or autoimmune disease under treatment) or major congenital defects, such that it would endanger the volunteer’s well-being or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13.Any evidence of thrombocytopenia or a bleeding disorder.
14.Infants who have participated in another trial or received any investigational agent within 30 days of enrolment.
15.Infant Parents/LAR Planned participation in another clinical trial during the trial period
16.Infant Parents/LAR is planning to leave the area of study before completion of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects achieving Seroprotection against diphtheria, tetanus, Hib; Seroresponsiveness against pertussis 4 weeks after three dose vaccination series of DTwP-Hib vaccine in the two treatment groups.  Day 0 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
unsolicited adverse events (AEs)
Serious Adverse Events (SAEs)
Solicited symptoms (local and general) 		 28 day (Day 0-28) follow-up period after each dose of study vaccine
during the entire study period
During the 3 day follow-up period after each vaccine dose 
 
Target Sample Size   Total Sample Size="244"
Sample Size from India="244" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   29/12/2014 
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="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Open Label,  Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of DTwP-Hib vaccine (Easyfour-TT, Panacea Biotec Ltd.) with Quadrovax®  (Tetravalent DTwP/Hib Vaccine, Serum Institute of India Ltd.) in Healthy Infants. Primary Objective of this study is to demonstrate non-inferiority of the test vaccine to the reference vaccine, with 90% power and alpha set at 0.025. The study will also evaluate the common local and systemic reactogenicity and safety in the two study arms. 
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