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CTRI Number  CTRI/2011/04/001675 [Registered on: 15/04/2011] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine
Biological
Preventive 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Post licensure clinical study to compare and evaluate safety, reactogenicity and Lot-to-Lot consistency of three production batches of liquid pentavalent DTwP-rHepB-HIB vaccine manufactured by BE LTD in healthy 6 to 8 week old infants.  
Scientific Title of Study   A multicentric double blind single arm randomised phase-IV study to evaluate the safety, reactogenicity & lot consistency of three production lots of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DTwP-rHepB-HIB-PIV/CTP-01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTSA Kishore 
Designation  Overall Trial Coordinator 
Affiliation  Biological E.Limited 
Address  Biological E.Limited 18/1&3, Azamabad

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214046  
Fax  04027675003  
Email  kishore.tsa@biologicale.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrTSA Kishore 
Designation  Overall Trial Coordinator 
Affiliation  Biological E.Limited 
Address  Biological E.Limited 18/1&3, Azamabad

Hyderabad
ANDHRA PRADESH
500020
India 
Phone  04030214046  
Fax  04027675003  
Email  kishore.tsa@biologicale.co.in  
 
Details of Contact Person
Public Query  
Name  MrShekhar Gupta 
Designation  Chief Opearting Officer 
Affiliation  D2L Pharma 
Address  D2L Pharma Research Solutions 1615, 5th Main, E Block, AECS Layout, Kundalahalli, Bangalore

Bangalore
KARNATAKA
560037
India 
Phone  09741111101  
Fax  918041534831  
Email  shekhar.gupta@d2lpharma.com  
 
Source of Monetary or Material Support  
Biological E.Limited (self) 
 
Primary Sponsor  
Name  Biological E Limited 
Address  Biological E.Limited 18/1&3, Azamabad, Hyderabad 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSarika Prasad  Aadithya Adhikari Hospital  Dept. of Paediatrics, Aadithya Adhikari Hospital, Contour Road, Gokulam, Mysore - 570002, Karnataka, India
Mysore
KARNATAKA 		 09880692465

dr.sarikaprasad@gmail.com 
Dr Sanjay Lalwani  Bharti Hospital & Research Centre  Dept. of Paediatrics, Bharti Hospital & Research Centre, Bharti Vidya Peeth Deemed University Medical College, Katraj-Dhankawadi, Pune - 411043, Maharashtra, India
Pune
MAHARASHTRA 		 09373314322

sanjaylalwani2007@rediffmail.com 
Dr Krishna Murthy B  Cheluvamba Hospital  Dept. of Paediatrics, Cheluvamba Hospital, Irwin Road, Mysore - 570001, Karnataka, India
Mysore
KARNATAKA 		 0944805007

bkm6@rediffmail.com 
DrJampana Venkateswara Rao  Gandhi Hospital  Dept. of Paediatrics, Gandhi Hospital, Musheerabad, Secunderabad - 500003, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 		 09848027709

dr_jvrao@yahoo.co.in 
Dr Patil Vishwanath Dondappa  J.N.Medical College  Dept. of Paediatrics, J.N.Medical College, KLE University, KLES Dr Prabhakar Kore Hospital& Medical Research Centre, Nehru Nagar, Belgaum - 590010, Karnataka, India
Belgaum
KARNATAKA 		 09448190231

drvdpatil@jnmc.edu 
Dr Mallikarjunaiah  K.C General Hospital  Dept. of Paediatrics, K.C General Hospital, 5th Cross,Malleshwaram, Nr Malleswaram Police Station, Bangalore - 560003, Karnataka, India
Bangalore
KARNATAKA 		 09008999330

lakshmipathysr@gmail.com 
Dr Pandit Anand Nilkanth  KEM Hospital Research Centre  Dept. of Paediatrics, KEM Hospital Research Centre, Sardar Moodliar Road,Rastha Peth, Pune - 411011, Maharashtra, India
Pune
MAHARASHTRA 		 09822002327

kemhrc@vsnl.com 
DrPVenugopal   King George Hospital   Dept. of Paediatrics, King George Hospital (KGH), Near Collectorate Maharanipeta, Visakhapatnam - 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 09848027203

venugopal_kgh@yahoo.com 
DrSharad Agarkhedkar  Padmashree Dr. D.Y. Patil Medical College  Dept. of Paediatrics, Padmashree Dr. D.Y. Patil Medical College, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA 		 09822030122

ashalaka@gmail.com 
DrRamachandra Keshav Dhongade  Sant Dnyaneshwar Medical Education Research Centre  Dept. of Paediatrics, Sant Dnyaneshwar Medical Education Research Centre, 695/A, Sadashiv Peth, Opp Vijay Talkies, Laxmi Road, Pune - 411030, Maharashtra, India
Pune
MAHARASHTRA 		 09822037483

ramdhongade@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee KLE University, Belgaum(J.N.Medical College)  Approved 
Ethics Committee MGIMS, Sewagram  Approved 
Ethics Committee of Mysore Medical College, Research Institute and Associated Hospital(Cheluvamba Hospital)  Approved 
Human Ethics Committee, Gandhi Hospital  Approved 
Independent Ethics Committee Consultants(K.C General Hospital)  Approved 
Institute Ethics Committee, Padmashree Dr. D. Y. patil Medical College, Pune  Approved 
Institutional Ethics Committee King George Hopital, Visakhapatnam  Approved 
Institutional Ethics Committee, Bharti Vidyapeeth Deemed University(Bharti Hospital & Research Centre)  Approved 
Mysore Clinical Research Ethics Committee(Aadithya Adhikari Hospital)  Approved 
Sant Dnyaneshwar Medical Education Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Preventive protection against Diphtheria, Tetanus, Petussis, Hepatitis-B and Haemophilus Influenzae type B diseases 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Batch-A: BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five)   0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses in anterolateral aspect of the thigh. 
Intervention  Batch-B: BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five)   0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses in anterolateral aspect of the thigh. 
Intervention  Batch-C: BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine (Combe Five)   0.5mL per dose administered intramuscularly in 3 dose schedule with 28 days interval between doses in anterolateral aspect of the thigh. 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  56.00 Day(s)
Gender  Both 
Details  Intended subjects will be healthy infants between 6-8 weeks of age, of either gender at the time of 1st vaccination.
Written informed consent obtained from the subjects parent(s) or legally acceptable representative / guardian.
Healthy infants with weight equal to or more than 3300 gms at the time of 1st vaccination.
Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature).
Healthy infants born to mothers sero-negative to HIV, HBV and HCV as confirmed by blood tests on the mother or based on maternity discharge summary.
Subjects or their mothers not participating in any other clinical trials.
Infants without contraindications or precautionary circumstances for participating in the trial.
Ability of the subjects parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.

 
 
ExclusionCriteria 
Details  Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of BCG &/or oral/injectable polio vaccine.
Current illness (especially fever) or any acute or congenital illness or disability.
Subjects receiving immunosuppressive therapy.
Known or suspected allergy to any of the vaccine components.
Any sign or symptom or systemic dysfunction, especially of the central nervous system (CNS).
Known family history of SIDS (Sudden Infant Death Syndrome).
Planned or elective surgery during the course of the study.
Infants who have received any blood products, any dose of corticosteroids, cytotoxic agents or radiotherapy.
Subjects and their mothers who have participated in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
Inability or unwillingness to abide by the requirements of the protocol.
Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Solicited local and systemic adverse events (AEs).
2.Solicited local and systemic adverse events (AEs).
3.Solicited and unsolicited adverse events (AEs).
4.Rate of SAEs and medically attended AEs.
5.Vital signs (Pulse, axillary body temperature and Respiratory rate).
 		 1.During first 60 minutes of vaccine administration at each dose.
2.During 7-day (Day 0-6) post vaccination period.
3.During the subsequent follow up period up to 28th day.
4.Until 84 days after the first vaccination.
5.At each visit.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Geometric mean titres(GMTs) estimation.
2.Seroprotection rates (SPR) as defined by percentage of subjects with Anti D,T,wP,rHepB,Hib above their respective cut off values.
3.Seroprotective cut off values as defined by percentage of subjects based on the cutoff values as per kits used.
4.Proportion of subjects achieving 4-fold rise in anti-D,T,wP,rHepB,Hib antibody titres.  		 1.At screening and again at Day 84 in each of the lot groups
2.At day 84
3.At day 84
4.At day 84 
 
Target Sample Size   Total Sample Size="660"
Sample Size from India="660" 
Final Enrollment numbers achieved (Total)= "660"
Final Enrollment numbers achieved (India)="660" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2011 
Date of Study Completion (India) 14/09/2011 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A multicentric double blind single arm randomised phase-IV study to evaluate the safety, reactogenicity & lot consistency of three production lots of BE’s combined liquid pentavalent DTwP-rHepB-HIB vaccine administered at 6-10-14 weeks schedule to 6-8 week old healthy Indian infants at 10 study sites.

All the study sites will be located within India. There will be a total of 660 healthy infants of either sex in the age group of 6-8 weeks. A 3-dose vaccination schedule at 6-10-14 weeks of age as per WHO-EPI guidelines will be followed in all the three lot groups

The primary outcome measure is to evaluate safety and reactogenicity of BE’s combined pentavalent DTwP-rHepB-HIB liquid vaccine up to 28 days after the 3rd dose of the primary immunisation schedule of 6-10-14 weeks .

The secondary outcomes will be to a) evaluate the equivalence between the three production lots in terms of geometric mean titre ratio against Diphtheria, Pertussis, Tetanus, HBsAg and PRP-T antigens at day 84 (28 days after 3rd dose); b) compare the immunogenicity between three production lots in terms of proportion of subjects achieving seroprotection with anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP antibody titres at day 84 (28 days after 3rd dose); c) compare proportion of subjects achieving fold rise in anti-Diphtheria, anti-Pertussis, anti-Tetanus, anti-HBsAg and anti-PRP-T antibody titres, above the sero-protection cut off value, at Day 84 (28 days after 3rd dose).

 
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