| CTRI Number |
CTRI/2024/02/063223 [Registered on: 27/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| 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 and immunogenicity of liquid DTwP-rHepB-HIB-IPV vaccine when administered in healthy infants of 6-8 weeks. |
|
Scientific Title of Study
|
A prospective randomised active controlled Phase-II safety and immunogenicity study with 3-doses of Biological E’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) in 6-8 weeks old infants. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT084/LHV-P-II/CTP-01 Version :1.0 dated:15.09.23 |
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 |
General Manager- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Room No:01,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 |
Ms Biological E Limited |
| Address |
Plot No I, Phase II, Kolthur Village, Shameerpet, Medchal- Malkajgiri District, Telangana-500078 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Kumar Pandey |
ESIC Medical College & Hospital |
Department of Physiology,
ESIC Medical College & Hospital, Room No. 4007, 4th
Floor, NH-3 behind BK Hospital New Industrial
Town-121001,India
Faridabad
HARYANA |
07042918222
drpandeyak@yahoo.co.in |
| Dr Jai Prakash Narayan |
JLN Medical College |
Department of Paediatrics,
JLN Medical College ,2nd Floor, Kala Bagh,305001- India
Ajmer
RAJASTHAN |
09414136888
narayan_jaiprakash@yahoo.co.in |
| Dr BS Chakravarthy |
King George Hospital |
Dept of Paediatrics,
King George Hospital, Collectorate junction, 1st floor, Maharanipeta- 530002, India
Visakhapatnam
ANDHRA PRADESH |
09848253535
chakravarthy.kghamc@gmail.com |
| Dr N S Mahantshetti |
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Paediatrics,
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, 2nd Floor,Department of Medicine, Nehru Nagar-590010, India
Belgaum
KARNATAKA |
09448157237
niranjanakle@gmail.com |
| Dr Madhukar Pandey |
Shubham Sudbhawana Superspeciality Hospital |
Department of Paediatrics,
2nd Floor, B 31 by 80, 23B - Bhogabeer, Lanka,- 221005-India
Varanasi
UTTAR PRADESH |
09839439464
pandeymadhukar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| IEC King George hospital, |
Approved |
| Institutional Ethics Committee - Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee ESIC |
Approved |
| Institutional Ethics Committee Shubham Sudbhawana Super Speciality Hospital |
Approved |
| Institutional Ethics Committee, KLE University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
BE’s Liquid Hexavalent (DTwP-rHepB-HIB-IPV) Liquid Vaccine (Test Vaccine) full dose strength of IPV. |
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. |
| Intervention |
BE’s Liquid Hexavalent (DTwP-rHepB-HIB-IPV) Liquid Vaccine (Test Vaccine) half dose strength of IPV. |
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 |
Licensed Hexavalent(DTwP-HepB-Hib-IPV) 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. |
|
|
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, 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).
5. Subjects and or their mothers not participating in any other clinical trials.
6. Infants without contraindications or precautionary circumstances for participating in the trial.
7. Ability of the subject’s parent or legally acceptable representative or guardian to understand and comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
|
|
| ExclusionCriteria |
| Details |
1. Child in care
2. Prior immunization with DTP, Hepatitis-B or HIB vaccine with the exception of birth dose BCG, Hepatitis B & oral polio vaccine.
3. Co-administration of any oral or injectable polio vaccine during the course of the study.
4. Current illness (especially fever) or any acute or congenital illness or disability.
5. Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and or H. influenzae type b diseases
6. Subjects receiving immunosuppressive therapy.
7. Known or suspected allergy to any of the vaccine components.
8. Any sign or symptom or 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, any dose of corticosteroids, cytotoxic agents or radiotherapy.
12. Subjects and or 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.
13. Inability or unwillingness to abide by the requirements of the protocol.
14. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
15. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Solicited local adverse reactions and systemic events
2.Solicited local and systemic adverse events (AEs)
3.Unsolicited adverse events (AEs)
4.Rate of SAEs, medically attended AEs and AEs of special interest (AESI) |
1. during first 60 minutes of vaccine administration after each dose
2.during 7-day (Day 0-6) post vaccination period
3.during the subsequent follow up period i.e., 28 days after each dose
4.for the total study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects seroconverted and or seroprotected with anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP-T and serotype specific anti-Polio antibodies |
At Day 84 (28 days’ post 3rd dose). |
| Geometric mean concentrations titres (GMC Ts) for anti-Diphtheria, anti-Tetanus, anti-Pertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres |
At baseline and again at Day 84 (28 days’ post 3rd dose) from baseline (day 0). |
| Proportion of subjects achieving ≥2-fold and ≥4-fold rise in anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres |
At Day 84 (28 days’ post 3rd dose) from baseline (day 0) |
| Geometric mean fold rise (GMFR) for anti-Diphtheria, anti-Tetanus, anti-wPertussis, anti-HBsAg, anti-PRP and serotype specific anti-Polio antibody concentrations or titres |
At Day 84 (28 days’ post 3rd dose) from baseline (day 0). |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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)
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 phase II, prospective, open label randomized study assessing safety and
immunogenicity of BE’s Liquid Hexavalent Vaccine (DTwP-rHepB-Hib-IPV) compared
with a licensed comparator.
A
total of 180 healthy 6-8 weeks old infants will be enrolled into the study
based on recruitment criteria set.
The study will be conducted in compliance with GSR 227(E),
ICH and Indian good clinical practice guidelines in force at the time of study
conduct.
|