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CTRI Number  CTRI/2015/02/005578 [Registered on: 25/02/2015] Trial Registered Prospectively
Last Modified On: 16/02/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the efficacy and safety of a New Fully Liquid six in one vaccine ( DTwP-HepB-Hib-IPV) with a five in one vaccine (DTwP-HepB-Hib) given along with a polio vaccine 
Scientific Title of Study   An Open Label, Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants. 
Trial Acronym  EasySix study 
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/CR/2013/02/CT/ESIX Version Number: 03 dated 13-10-14  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalitendu Mohanty 
Designation  GM-Clinical Research 
Affiliation  Panacea Biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road South West DELHI India

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 Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road South West DELHI India

South West
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 Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road South West DELHI India

South West
DELHI
110044
India 
Phone  01141679000  
Fax  01141578085  
Email  lalitendumohanty@panaceabiotec.com  
 
Source of Monetary or Material Support  
Panacea Biotec Ltd,B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044 
 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr J Venkateswara Rao  Gandhi Hospital  Department of Pediatrics Gandhi Hospital Musheerabad
Hyderabad
ANDHRA PRADESH 		 9848027709

dr_jvrao@yahoo.co.in 
Dr P Venugopal  King George Hospital  Department of Pediatrics, King George Hospital
Visakhapatnam
ANDHRA PRADESH 		 9848027203

venugopal_kgh@yahoo.com 
Dr Ram Dhongade   Sant Dnyaneshwar Medical Education  Pediatric,Sadashiv Peth Opp Vijay Talkies Laxmi Road
Pune
MAHARASHTRA 		 9822037483

ramdhongade@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gandhi Hospital  Submittted/Under Review 
Institutional Ethics Committee, King George Hospital  Approved 
Sant Dnyaneshwar Medical Education Research Centre Institutional Review Board  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primary immunization against Diphtheria, Pertussis, tetanus, hepatitis B, Haemophilus influenzae and polio 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EasySix (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.)  0.5 ml of the EasySix vaccine will be administered by deep intramuscular injection in the anterolateral aspect of thigh at day 0, day 28 and day56 
Comparator Agent  Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.)  0.5 ml of the Imovax Polio® vaccine will be administered by deep intramuscular injection in the anterolateral aspect of thigh at day 0, day 28 and day56 
Comparator Agent  Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.)  0.5 ml of the Pentavac SD® vaccine will be administered by deep intramuscular injection in the anterolateral aspect of thigh at day 0, day 28 and day 56 
 
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 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  3.3 Kg at the time of enrollment.
2. Infants less than 6 weeks or more than 10 weeks of age.
3. Known HBsAg positivity in mother.
4. Infants having history of immunization with vaccine other than zero polio, BCG and birth dose of HepB
5. Infants with history of infection potentially related to any of the agents targeted by the DPT-HepB-Hib-IPV vaccine
6. 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.
7. History of household contact and/or intimate exposure to an individual with suspected poliomyelitis.
8. Fever >38o C in past 3 days
9. Any evidence of acute illness or infection within past 7 days.
10. Planned or elective surgery during the course of the study.
11. 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
12. Infants who have received any blood products, cytotoxic agents or radiotherapy.
13. Infants with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
14. Have any clinically significant chronic disease (for example, cardiac, pulmonary, renal, gastrointestinal, hepatic, endocrine, cancer, skin or psychiatric disease or disorder or autoimmune disease under treatment) or major congenital defects, such that it would endanger the volunteer’s wellbeing or which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
15. Any evidence of thrombocytopenia or a bleeding disorder.
16. Infants who have participated in another trial or received an investigational agent within 30 days of enrolment.  
 
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, Hepatitis B, Hib; seroresponsiveness against pertussis; seroconversion against Polio virus type 1, type 2 and type 3, 4 weeks after three dose vaccination series of DTwP-HepB-Hib-IPV vaccine in the two treatment groups  Day 0 and Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
•Incidence of solicited local and systemic reactions within 4 days of each vaccine dose (day 0-3).
•Incidence of unsolicited adverse events up to 4 weeks after last vaccination.
•Incidence of SAE during the entire study period. 		 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="284"
Sample Size from India="284" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/03/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An Open Label,  Randomized, Multicenter study to Evaluate and Compare the Immunogenicity and Reactogenicity of EasySixTM (New Fully Liquid Hexavalent DTwP-HepB-Hib-IPV Vaccine, Panacea Biotec Ltd.) with Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine; Sanofi Pasteur India Pvt. Ltd.) in Healthy Infants

The study will enroll Infants 6-10 weeks of age. Subjects will be randomized to receive either 3-dose primary vaccination series of Fully liquid hexavalent DTwP-HepB-Hib-IPV vaccine (EasySixTM) of Panacea Biotec Ltd. as a single intramuscular injection or Pentavac SD® (Pentavalent DTwP-HepB/Hib Vaccine, Serum Institute of India Ltd.) Co Administered with Imovax Polio® (Salk Based Inactivated Polio Vaccine, Sanofi Pasteur India Pvt. Ltd.) as two separate injections intramuscularly.  The vaccinations will be done at 0, 4 and 8 weeks of enrollment. Local and solicited reactions will be observed on each vaccination day (up to 30 minutes) and on 4 subsequent days (day 0-3) after each dose. Adverse events will also be monitored for 28 days after each vaccination. Blood samples will be obtained from subjects at visit 1(before first vaccination and at visit 4 (Follow up visit) for estimation of Anti-diphtheria, Anti-tetanus, Anti-PRP, Anti- HBsAg, Anti-pertussis, Anti pertussis toxin antibodies and neutralizing antibodies against polio. The samples will be sent to Panacea’s central laboratory for analysis 
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