CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/04/085479 [Registered on: 23/04/2025] Trial Registered Prospectively

Last Modified On:

21/04/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine
Biological
Preventive

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A clinical study to assess the safety of Biological Es Hexavalent vaccine in 6 to 8 weeks old healthy babies.

Scientific Title of Study

A prospective, single blind, randomised, active controlled Phase-III study to assess the immunogenicity and safety of Biological E’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) in 6-8 weeks old healthy infants in a 6-10-14 weeks dosing schedule.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
BECT094/LHV-Phase-III/CTP-01Version :1.0 dated:16.12.24	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Subhash Thuluva
Designation	Sr. Vice President- Clinical Development
Affiliation	Biological E.Limited
Address	Clinical Development Dept, 2nd floor, Room No:04,Road No.35,Jubilee Hills Hyderabad TELANGANA 500033 India
Phone	04071216248
Fax
Email	subhash.thuluva@biologicale.com

Details of Contact Person
Scientific Query

Name	Dr Subhash Thuluva
Designation	Sr. Vice President- Clinical Development
Affiliation	Biological E.Limited
Address	Clinical Development Dept, 2nd floor, Room No:04,Road No.35,Jubilee Hills TELANGANA 500033 India
Phone	04071216248
Fax
Email	subhash.thuluva@biologicale.com

Details of Contact Person
Public Query

Name	Mr Subba Reddy GV
Designation	Associate Vice President- Clinical Development
Affiliation	Biological E.Limited
Address	Clinical Development Dept, 2nd floor, Room No:03,Road No.35,Jubilee Hills Hyderabad TELANGANA 500033 India
Phone	04071216240
Fax
Email	subbareddy.gunneri@biologicale.com

Source of Monetary or Material Support

Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India

Primary Sponsor

Name	Biological E.Limited
Address	18/1&3, Azamabad, Hyderabad - 500020, Telangana, India
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
None	None

Countries of Recruitment

India

Sites of Study

No of Sites = 48
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ravi B Nagarajaiah	Adichunchanagiri Hospital	Department of General Medicine,Clinical Trial Centre , OPD Block, Ground floor, B G Nagara, Nagamangala Taluk-571448 Mandya KARNATAKA	09448323893 ravibn972@yahoo.com
Dr Nagarjuna Chadalavada	Aditya Multispecialty Hospital	Department of Paediatrics, 13-3-52, 3rd Line, 1st floor,Gunturuvari Thota, Kothapet, Beside Peoples Trauma -522001 Guntur ANDHRA PRADESH	8500454689 researchaditya26@gmail.com
Dr Bhagirathi Dwibedi	All India Institute of Medical Sciences	Department of Paediatrics, All India Institute of Medical Sciences, OPD block, Ground floor, Sijua, Patrapada, Bhubaneswar-751019 Baleshwar ORISSA	09337908486 dr.dwibedi@gmail.com
Dr Atul Jindal	All India Institute Of Medical Sciences (AIIMS)	Department of Paediatrics, Paediatric OPD, Consultant room, First floor, B block, Gate No-5, Great Eastern Road, opposite Gurudwara, AIIMS Campus, Tatibandh-492099 Raipur CHHATTISGARH	8224014667 dratuljindal@gmail.com
Dr Hira Lal Bhalla	All India Institute of Medical Sciences (AIIMS)	Department of Pharmacology & Therapeutics, OPD block, 3rd floor, Kunraghat-273008 Gorakhpur UTTAR PRADESH	9761715236 hirabhalla@gmail.com
Dr Shailesh Patil	Belagavi Institute of Medical Sciences	Department of Paediatrics, 3rd floor, OPD block,BIMS Building, Dr. B. R. Ambedkar Road, Sadashiv Nagar-590001 Belgaum KARNATAKA	09480454944 bimsclinicalresearch@gmail.com
Dr Ramesh M	BGS Global Institute of Medical Sciences	Department of Paediatrics, No. 67, OPD block, 2nd floor, BGS Health and Education city, Uttarahalli Road, Kengeri -560060 Bangalore KARNATAKA	09741333320 drrameshm.research@gmail.com
Dr Ramadas Manikrao Dahiphale	Bharati Vidyapeeth (Deemed to be University) Medical College Hospital and Research Centre	Department of Paediatrics, Ground floor, OPD block, Pune-Satara Road, Dhankawadi-411043 Pune MAHARASHTRA	9780579053 dr_ramadas@yahoo.com
Dr Prashanth S	Cheluvamba Hospital	Department of Paediatrics, Pediatric block, Ground floor,Sitharanga OPD, Unit B, Mysore Medical College & Research Institute, Irwin Road-570001 Mysore KARNATAKA	9606352062 drprashanths10@gmail.com
Dr Jaishree Vasudevan	Chettinad Hospital & Research Institute	Department of Paediatrics, Chettinad Academy of Research and Education,Chettinad Health City, Paediatric OPD,1st floor, SH 49A, Kelambakkam Dist.-603103 Chennai TAMIL NADU	9444362134 drjaishree.research@gmail.com
Dr Kishori Sharan Agarwal	Chirayu Hospital	Department of Paediatrics, Ground Floor of OPD, Kalwar Road, Hathoj-302012 Jaipur RAJASTHAN	9116943306 agarwalkishore@yahoo.com
Dr Deepshikha Kamra	Christian Medical College & Hospital	Department of Community Medicine, OPD Block, First floor, Brown Road, CMC Campus, -141008 Ludhiana PUNJAB	9463034958 deepshikhakamra@gmail.com
Dr Kush Damodar Jhunjhunwala	Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre	Department of Paediatrics, Datta Meghe Medical College and Shalinitai Meghe Hospital and Research Centre, OPD Block, Ground floor,Hingna Road, Wanadongari-441110 Nagpur MAHARASHTRA	7122776500 kush_73@yahoo.co.in
Dr Javadekar Bakul Balchandra	Dhiraj Hospital and S. B. K. Shah Medical Institute & Research Centre,	Department of Paediatrics, OPD No:10, Ground Floor, Sumandeep Vidhyapeeth At & Po Piparia, Ta. Waghodia, Vadodara GUJARAT	9925014448 dean.medical@sumandeepvidyapeethdu.edu.in
Dr Satish Chandran Vazhappilly Ramachandran	Elite Mission Hospital	Department of Paediatrics, P.B No. 1414, Koorkenchery-680007, Thrissur KERALA	6282126420 drsatishchandran01@gmail.com
Dr Onkar Singh Bhinder	ESIC Medical College & Hospital	Department of Paediatrics, Room no-8037, 8th floor, Paediatric ward, OPD building, NH-3, NIT, Faridabad-121001 Faridabad HARYANA	7529864316 o.bhinder@gmail.com
Dr Mohd Haseeb Nazeeb Mohd	Galaxy Superspeciality Hospital and Research Institute	Department of Paediatrics, Agnihotra Chowk,OPD Block, First floor, Cabin No:05, Opposite to Punjab National bank Ulkanagari -431001 Aurangabad MAHARASHTRA	9890057325 dr.haseebmohd.ped@gmail.com
Dr Nehal Suryakant Patel	GMERS Medical College and Civil Hospital	Department of Paediatrics, Block A, 1st floor, Near Gujarat High Court, S.G. Highway, Sola, Ahmedabad-380061 Ahmadabad GUJARAT	7567897517 nehal_pedia@yahoo.com
Dr Pareshkumar A Thakkar	Govt. Medical College Baroda & SSG General Hospital	Department of Paediatrics, 1st floor of OPD, Jail Road, Indira Avenu, Anandpura, 390001 Vadodara GUJARAT	9426032150 pareshthakkar@yahoo.com
Dr Sanjeeva GN	Indira Gandhi Institute of Child Health	Department of Paediatrics, OPD Block, Ground floor, South Hospital Complex, Dharmaram College Post-560029 Bangalore KARNATAKA	9945657034 sanju.gn26@gmail.com
Dr Monjori Mitra	Institute of Child Health (ICH)	Department of Paediatrics, 11OPD block, Ground floor, Room no 10, Dr Biresh Guha Street, Kolkata -700017 Kolkata WEST BENGAL	9831075734 monjorimr@gmail.com
Dr Mruthunjay Dash	Institute of Medical Science & SUM Hospital	Department of Paediatrics, Paediatric OPD, 3rd floor, Room no -2,K-8, Kalinga Nagar, Ghatikia,Bhubaneswar-751003 Baleshwar ORISSA	9437163601 m.dash74@gmail.com
Dr Jai Prakash Narayan	JLN Medical College	Department of Paediatrics, OPD Block of Ground Floor, Kala Bagh-305001 Ajmer RAJASTHAN	9314294402 narayan_jaiprakash@yahoo.co.in
Dr M D Ravi	JSS Hospital	Department of Paediatrics, 1st Floor Paediatric OPD, Mahatma Gandhi Road, Fort Mohalla-570004 Mysore KARNATAKA	9880629506 ravimdped@gmail.com
Dr Vasanthi Thiruvengadam	Kanchi Kamakoti Childs Trust Hospital	Department of Paediatrics, Room No-1, First floor, 12-A Nageswara Road, Nungambakkam-600034 Chennai TAMIL NADU	9840089958 dr_vasanthi@hotmail.com
Dr B S Chakravarthy	King George Hospital	Department of Paediatrics, 1st floor, Room no 9, Collectorate Junction, Maharanipeta– 530002 Visakhapatnam ANDHRA PRADESH	9848253535 chakravarthy.kghamc@gmail.com
Dr N S Mahantshetti	KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre	Department of Paediatrics, 2nd floor, Sharawathi ward, opposite psychiatric ward, Nehru Nagar - 590010 Belgaum KARNATAKA	9448157237 niranjanakle@gmail.com
Dr B Vijai Anand Babu	Kurnool Medical College/Government General Hospital	Department of Paediatrics, 1st floor, Professor room, Budhawara Peta, Alluri Sitarama Raju Nagar -518002 Kurnool ANDHRA PRADESH	9000718884 vijaianandbangi@gmail.com
Dr Anju JK Mehrotra	Latha Mangeshkar Hospital	Department of Paediatrics, OPD on Ground Floor, 5YMCA Complex Maharajbagh Road, Sitabuldi - 440012 Nagpur MAHARASHTRA	9325160804 mehrotraanju@gmail.com
Dr Mohit Poddar	Maharaja Agrasen Superspeciality Hospital	Department of Paediatrics, Sec 7, Paediatric OPD, Second floor, Central Spine, Vidyadhar Nagar-302039 Jaipur RAJASTHAN	9829666655 drmohitpoddar@gmail.com
Dr Sridhar PV	Mandya Institute of Medical Science	Department of Pediatrics, OPD Block, Ground floor, MC Road, Nehru Nagar-571401 Mandya KARNATAKA	9845392043 drshridharpv@gmail.com
Dr Jog Pramod Prabhakar	Medipoint Hospitals Pvt. Ltd	Department of Paediatrics, 1st Floor of OPD, 241/1, New D.P.Road, Aundh-411007 Pune MAHARASHTRA	9422309677 drpramod.medipoint@gmail.com
Dr Prashanth M V	Medstar Speciality Hospital	Department of Pediatrics & Neonatology,Ground Floor of OPD, #641/17/1/3, Kodigehalli Main Road, Sahakar Nagar-560092 Bangalore KARNATAKA	9480390855 medstarclinicalresearch@gmail.com
Dr N Ravi Kumar	Niloufer Hospital for Women and Children	Department of Paediatrics, Redhills, Paediatrics OPD1st floor, Room No:1 Lakdikapool-500004 Hyderabad TELANGANA	9490919293 ravik1961@yahoo.com
Dr Girish Nanoti	NKP Salve Institute of Medical sciences & Research Centre & Lata Mangeshkar Hospital	Department of Paediatrics, 1st floor of OPD Building, Digdoh Hills, Hingna Road - 440019 Nagpur MAHARASHTRA	9422492050 girish.nanoti.gn@gmail.com
Dr Paruchuri Anil Kumar	Old Government General Hospital (Associated By Govt. Siddhartha Medical College)	Department of Paediatrics, Two Town, 1st floor, Hanumanpet,Vijayawada - 520002 Krishna ANDHRA PRADESH	9848527270 paruchuriak70@gmail.com
Dr Ramanath Andy Karayalar	Panimalar Medical College Hospital & Research Institute	Department of Paediatrics, OPD Room No: 240, 1st floor, Varadharajapuram, Poonamallee- 600123 Chennai TAMIL NADU	9884750160 chandra.ramanath82@gmail.com
Dr B Sudhakar	Priya Children Hospital	Department of Paediatrics, OPD Block, Ground floor, D.No. 57, 12-3, Panta Kaluva Road, Maruti Colony, New P & T Colony, Patamata, Vijayawada-520010 Krishna ANDHRA PRADESH	9885066297 drctresearch@gmail.com
Dr Savita Verma	PT. B D Sharma Post Graduate Institute of Medical Sciences	Department of Pharmacology, 2nd floor, University of Health Sciences, Room No:428 -124001 Rohtak HARYANA	9812283746 savita_verma@hotmail.com
Dr Dhongade Ramchandra Keshav	Sant Dnyaneshwar Medical Education Research Centre	Department of Paediatrics, Ground floor of OPD Block, 695-A, Sadashiv Peth, Opp. Vijay Talkies, Laxmi Road-411030 Pune MAHARASHTRA	9822037483 ramdhongade@hotmail.com
Dr Pravakar Mishra	Sardar Vallabhbhai Patel Post Graduate Institute of Paediatrics and SCB Medical College and Hospital	Department of Paediatrics, SCRC Building, Ground floor, Room no-9, Oriya Bazar, Cuttack-753002 Cuttack ORISSA	9437028882 drpravakar@yahoo.co.in
Dr Neeraj Kumar	Sarojini Naidu Medical College & Hospital	Department of Paediatrics, Ground floor, Moti Katra, Mantola -282003 Agra UTTAR PRADESH	9756966669 neerajyadu18@gmail.com
Dr Hetal Vora	Shardaben Chimanlal Lalbhai Municipal General Hospital	Department of Paediatrics, OPD Block, Room no:103,1st floor, Bhagwati Nagar, Saraspur-380018 Ahmadabad GUJARAT	8306050555 research.oberon@gmail.com
Dr Madhukar Pandey	Shubham Sudbhawana Superspeciality Hospital	Department of Paediatrics, OPD 4th floor, B31/80-23B, Bhogabeer, Lanka-221005 Varanasi UTTAR PRADESH	9839439464 pandeymadhukar@gmail.com
Dr Elayaraja Sivaprakasam	Sri Ramachandra Hospital	Department of Paediatrics, Dental College Basement No. 1, G-Block,Ramachandra Nagar, Porur-600116 Chennai TAMIL NADU	9841036110 elayaped@gmail.com
Dr G Balakishor	St.Theresas Hospital	Department of Paediatrics, 1st Floor,Room no 5,Erragadda Main Road, Czech Colony Sanath Nagar-500018 Hyderabad TELANGANA	9949046236 drbalakishor@gmail.com
Dr Kalantri Reena Gopaldas	Suyog Hospital	2nd Floor of OPD, B-wing, Krushi Utapanna Bazar Samiti Sankul, Dindori Road, Panchavati-422003 Nashik MAHARASHTRA	9420590111 drreenarathi@yahoo.in
Dr Manish Narang	UCMS & GTB Hospital	Department of Paediatrics, MCH Block, Ground floor,Room no 605, Dilshad Garden -110095 New Delhi DELHI	9811036569 manish_2710@yahoo.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 48
Name of Committee	Approval Status
CARE-IHEC for Faculty Research, Chettinad Academy of Research And Education	Approved
Ethics Committee of Ishwar Institute of HealthCare	Approved
Ethics Committee of KKCTH and CTMRF	Approved
Ethics committee St Theresas Hospital	Approved
Guru Teg Bahadur Hospital Ethics Committee	Approved
IEC Adichunchanagiri Institute of Medical Sciences	Approved
IEC Aditya Multispeciality Hospital	Approved
IEC Chirayu Hospital	Approved
IEC IMS and SUM Hospital	Approved
IEC, King George Hospital	Approved
IEC, Maharaja Agrasen Hospital	Approved
IEC-Indira Gandhi Institute of Child Health	Submittted/Under Review
IEC-MMC and RI and Associated Hospital Mysore Medical College and Research Institute	Approved
IEC-Sant Dnyaneshwar Medical Education, Research Centre	Approved
Independent Ethics Committee-Fusion Clinical research,	Approved
Institute Ethics Committee, AIIMS Raipur	Approved
Institution Ethics Committee, MIMS	Approved
Institutional Ethics Committee for ESIC	Approved
Institutional Ethics Committee for Human Research- SSG	Approved
Institutional Ethics Committee GMERS	Submittted/Under Review
Institutional Ethics Committee ICH Institute of Child Health	Approved
Institutional Ethics Committee, Christian Medical College & Hospital	Approved
Institutional Ethics Committee, BVDU	Approved
Institutional Ethics Committee, Jawahar Lal Nehru Medical College	Approved
Institutional Ethics Committee, SCB Medical college & Hospital	Submittted/Under Review
Institutional Ethics Committee, SV, Sumandeep Vidyapeeth	Approved
Institutional Ethics Committee, BGS Global Institute of Medical Sciences	Approved
Institutional Ethics Committee, Elite Mission Hospital	Submittted/Under Review
Institutional Ethics Committee, JSS Medical College	Approved
Institutional Ethics Committee, KLE University	Approved
Institutional Ethics Committee, Kurnool Medical College	Approved
Institutional Ethics Committee, NHLIEC	Approved
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences	Approved
Institutional Ethics Committee, NKP Salve Institute of Medical Sciences, Lata Mangeshkar	Approved
Institutional Ethics Committee, Osmania Medical College	Submittted/Under Review
Institutional Ethics Committee, PGIMS UHS	Approved
Institutional Ethics Committee, S.N Medical College	Approved
Institutional Ethics Committee, SMC and GGH,	Approved
Institutional Ethics Committee- All India Institute of Medical Sciences, BBSR	Approved
Institutional Ethics Committee- Belagavi Institute of Medical Sciences	Approved
Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur	Submittted/Under Review
Instutional Ethics Committee SRIHER	Approved
Medstar Speciality Hospital Ethics Committee	Approved
Penta-Med Ethics Committee-Medipoint Hospitals Pvt. Ltd	Approved
PMCHRI-IHEC, Panimalar Medical College Hospital & Research Institute	Approved
Shubham Sudbhawana Super Hospital, Ethics Committee	Approved
Signus Hospital Ethics Committee	Approved
SMHRC Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	vaccination against diphtheria, tetanus, pertussis, hepatitis B, H. influenzae type b and polio diseases.
Patients	(1) ICD-10 Condition: Z23\|\|Encounter for immunization,

Intervention / Comparator Agent

Type	Name	Details
Intervention	BEs Liquid Hexavalent (DTwP-rHepB-HIB-IPV) Liquid Vaccine	Each 0.5 mL will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus lateralis muscle) in three dose schedule at 6, 10, 14 weeks of age.
Comparator Agent	Marketed Pentavalent(DTwP-rHepB-HIB) and Polio Vaccines	Each 0.5 mL of pentavalent and Polio vaccines will be administered intramuscularly in the anterolateral aspect of mid or upper thigh (vastus lateralis muscle) in three dose schedule at 6, 10, 14 weeks of age.

Inclusion Criteria

Age From	42.00 Day(s)
Age To	56.00 Day(s)
Gender	Both
Details	1. Intended subjects will be healthy infants between 6-8 weeks of age (42-56 days, both inclusive), of either gender at the time of 1st vaccination. 2. Written or thumb printed informed consent obtained from the subject’s parent(s) or legally acceptable representative prior to performing any study specific procedure. 3. Healthy infants with weight 3300gms at the time of 1st vaccination. 4. Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature) as judged by the investigator. 5. Infants with a minimal vaccination status for their age at the time of enrolment (Receipt of single birth dose of BCG, OPV and HBV vaccines (within 14 days of birth)). 6. Infants without contraindications or precautionary circumstances for participating in the trial. 7. Ability of the subject’s parent or legally acceptable representative/guardian to understand and comply with the requirements of the protocol.

ExclusionCriteria

Details

1. Child in care
2. Prior immunization and co-administration of any OPV or IPV, DTP, Hepatitis-B or Hib vaccine with the exception of birth dose BCG, Hepatitis B and OPV.
3. Current illness (especially fever) or any acute or congenital illness or disability.
4. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or H. influenzae type b diseases
5. Subjects receiving immunosuppressive therapy.
6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
7. Known or suspected allergy to any of the vaccine components. History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity likely to be exacerbated by any component of the study vaccines.
8. Any sign or symptom of systemic dysfunction, especially of the central nervous system (CNS).
9. Known family history of SIDS (Sudden Infant Death Syndrome).
10. Planned or elective surgery during the course of the study.
11. Infants who have received any blood products.
12. Subjects and / or their mothers who have participated / are participating in another clinical trial of an investigational agent within last 30 days or likely to participate during the study course.
13. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the administration of study vaccine (Day -29 to Day 0), or planned use during the study period.
14. Inability or unwillingness to abide by the requirements of the protocol.
15. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
16. Infant is a direct descendant (child or grand-child) of any person employed by the Sponsor, the Contract Research Organization (CRO) or the Study Site (including the PI and study site personnel).
17. 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

On-site computer system

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
The proportion of subjects sero-protected for anti-Diphtheria, anti-Tetanus, anti-PRP-T, anti-HBsAg, serotype-specific anti-Polio antibodies, and seroconverted for anti-Pertussis	At Day 84 (28 days post-third dose)

Secondary Outcome

Outcome	TimePoints
Proportion of subjects with solicited local adverse reactions and systemic events	during the first 30 minutes following vaccine administration after each dose
Proportion of subjects with solicited local and systemic adverse events (AEs)	during the 7-day (Day 0-6) post vaccination period
Proportion of subjects with unsolicited adverse events (AEs)	during the 28 day follow up period after each dose of vaccination
Proportion of subjects with occurrence, severity and causality of all the reported adverse events	28 days after each dose.
Rate of serious adverse events (SAEs) and medically attended AEs	for the total study period.
Proportion of subjects with SAEs	during the 6 months follow up period after the third dose of the vaccination
Geometric mean concentrations/titres (GMC/Ts) and GMFR for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations/titres	Both at baseline and again at Day 84
Number and proportion of subjects seroconverted in terms of serum IgG concentrations induced by 14 serotypes of BE-PCV14 and serum IgA concentrations induced by Rotavirus vaccine in both BE’s LHV and licensed comparator vaccinated subjects.	At day 84
Geometric mean concentrations/titres for anti-diphtheria, anti-tetanus, anti-pertussis, anti-hepatitis B, anti-haemophilus influenzae type b and anti-polio serotypes 1, 2 & 3, estimated in all three lots of BE’s LHV	at baseline and again at Day 84

Target Sample Size

Total Sample Size="4012"
Sample Size from India="4012"
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 3

Date of First Enrollment (India)

05/05/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - NO

Brief Summary

This is a prospective, single blind, randomized, active-controlled, phase-III study to evaluate immunogenicity and safety of Biological E’s Liquid Hexavalent Vaccine, administered to 6-8 weeks old healthy infants in 6-10-14 weeks dosing schedule.

The target population for this study would be 6-8 weeks old healthy infants of either gender, at the time of first dose administration. The total sample size to be enrolled would be 4012 healthy eligible subjects.

The study will be conducted in compliance with NDCT Rules, ICH and Indian good clinical practice guidelines in force at the time of study conduct.