| CTRI Number |
CTRI/2018/12/016692 [Registered on: 17/12/2018] Trial Registered Prospectively |
| Last Modified On: |
09/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
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A clinical study to evaluate safety and compare immune responses of two formulations of a combined 5-in-1 DTwP-HepB-Hib vaccine in children |
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Scientific Title of Study
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Phase III Safety and Immunogenicity of an Investigational versus the Licensed Formulation of the Pentavalent Vaccine (DTwP-HepB-Hib) SHAN 5® when administered as Three Dose Primary Series at 6-8, 10-12 and 14-16 Weeks of Age in Healthy Indian Infants and Safety and Immunogenicity of the Investigational SHAN 5® Formulation when administered as a Single Booster Dose at 12-24 Months of Age |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| SH504 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Naveena Aloysia Dcor |
| Designation |
Assistant General Manager, Clinical R&D |
| Affiliation |
Shantha Biotechnics Pvt Ltd |
| Address |
3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheerbagh, Hyderabad. 500004 Telangana, India
Hyderabad
TELANGANA
500004
India |
| Phone |
|
| Fax |
|
| Email |
Naveena.Aloysia@Sanofi.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Naveena Aloysia Dcor |
| Designation |
Assistant General Manager, Clinical R&D |
| Affiliation |
Shantha Biotechnics Pvt Ltd |
| Address |
3rd and 4th Floor, Vasantha Chambers, 5-10-173, Fateh Maidan Road, Basheerbagh, Hyderabad. 500004 Telangana, India
Hyderabad
TELANGANA
500004
India |
| Phone |
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| Fax |
|
| Email |
Naveena.Aloysia@Sanofi.com |
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Source of Monetary or Material Support
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| Shantha Biotechnics Pvt Ltd |
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Primary Sponsor
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| Name |
Shantha Biotechnics Pvt Ltd |
| Address |
3rd and 4th Floor, Vasantha Chambers, Fateh Maidan Road, Basheer Bagh, Hyderabad, Telangana, India-500004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasad Muley |
Dhiraj General Hospital |
Dept. of Pediatrics, Dhiraj General Hospital SBKS Medical College and Research Center, Sumandeep Vidyapeeth, Piparia, Waghodia,Vadodara, Gujarat - 391 760
Vadodara
GUJARAT |
9825282700
djg_48@yahoo.co.in |
| Dr Jayant Vagha |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Pediatrics, Acharya Vinoba Bhave Rural Hospital, Datta Megha Institute of Medical Sciences, Sawangi, Wardha, 442001
Wardha
MAHARASHTRA |
9890625338
jayantvagha@gmail.com |
| Dr Prashanth S |
Cheluvamba Hospital |
Dept. of Pediatrics, Cheluvamba Hospital, Mysore Medical College (MMC), Irwin Road, Mysore, Karnataka-570001.
Mysore
KARNATAKA |
8105028742
drprashanths10@gmail.com |
| Dr Jugesh Chhatwal |
Christian Medical College & Hospital |
Dept. of Pediatrics, Christian Medical College & Hospital, Brown Road, Ludhiana, Punjab – 141008
Ludhiana
PUNJAB |
9316919718
drjchhatwal@gmail.com |
| Dr IV Padmavathi |
Government Victoria Hospital |
Dept. of Pediatrics, Government Victoria Hospital, Chengala Rao Peta, Purna Market,Visakapatnam, Andhra Pradesh-530001
Visakhapatnam
ANDHRA PRADESH |
9666140568
ivpadmavathi.vgh@gmail.com |
| Dr Sonali Kar |
Kalinga Institute of Medical Sciences (KIMS) |
Department of Community Medicine, Campus-5, Kalinga Institute of Medical Sciences, Patia, Khordha, Bhubaneswar, Odisha-751024.
Khordha
ORISSA |
9438423273
sonsam72@yahoo.co.uk |
| Dr Sciddhartha Koonwar |
King Georges Medical University |
Dept. of Pediatrics, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh- 226003
Lucknow
UTTAR PRADESH |
9415102691
dr_sciddhartha@yahoo.com |
| Dr SM Dhaded |
KLES Dr. Prabhakar Kore Hospital & Medical Research Center |
Dept. of Pediatrics, KLES Dr Prabhakar Kore Hospital & Medical Research Centre , Nehrunagar Belagavi, Karnataka -590010.
Belgaum
KARNATAKA |
9844232586
drdhadedsm@gmail.com |
| Dr VN Tripathi |
Prakhar Hospital Pvt Ltd |
Dept. of Pediatrics, Prakhar Hospital PvtLtd, Arya Nagar, Kanpur, Uttar Pradesh – 208002
Kanpur Nagar
UTTAR PRADESH |
9415050777
drvntripathi@gmail.com |
| Dr Satyajit Mohapatra |
SRM Medical College Hospital & Research Center (SRMCH) |
Dept. of Pharmacology, SRM Medical College Hospital & Research Center, Potheri, Kattankulathur, Chennai, Tamilnadu-603203.
Chennai
TAMIL NADU |
9791161626
satyajit_mp@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF THE PRAKHAR HOSPITAL |
Approved |
| Institutional Ethics Commitee, KLE Academy of Higher Education and Research, Belagavi |
Approved |
| Institutional Ethics Committee, Christian Medical College and Hospital, Ludhiana |
Approved |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
| Institutional Ethics Committee, Mysore Medical College |
Approved |
| Institutional Ethics Committee, SRM Medical College Hospital & Research Center |
Approved |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
Vaccination for the prevention of tetanus, diphtheria, pertussis (whooping cough), hepatitis B (Hep B) and invasive Haemophilus influenzae type b (Hib) diseases. |
|
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Pentavalent DTwP-HepB-Hib vaccine (Shan5) |
Dose: 0.5ml, 3 dose series (at 6-8, 10-12 and 14-16 weeks of age) in infants and Single dose (at 12 to 24 months of age) in Toddlers. Route: Intramuscular |
| Comparator Agent |
Pentavalent DTwP-HepB-Hib vaccine (Shan5) |
Dose: 0.5ml, 3 dose series (at 6-8, 10-12 and 14-16 weeks of age) in infants. Route: Intramuscular |
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Inclusion Criteria
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| Age From |
42.00 Day(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
For Infants (Stage 1):
1. Infants between 6-8 weeks of age on the day of enrollment.
2. Healthy infants, born at full term of pregnancy (not less than 37 weeks) with a birth weight not less than 2.5 kg
3. Informed consent form signed by the parent or by the legally acceptable representative (LAR).
4. Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
For Toddlers (Stage 2):
1. Toddlers aged between 12-24 months of age on the day of enrollment and had received either the investigational or the licensed SHAN 5® vaccine formulation at 6-8, 10-12 and 14-16 weeks of age during stage 1 of the trial.
2. Informed consent form signed by the parent or by the LAR.
3. Subjects and Parent/LAR are able to attend all scheduled visits and to comply with all study procedures
|
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| ExclusionCriteria |
| Details |
1. Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period
2. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except BCG, birth dose OPV and birth dose of Hep B vaccine).
3. Planned receipt of any other vaccine within the period from 8 days before to 8 days after each trial vaccination except OPV.
4. For Stage 1 only: Previous vaccination against the diphtheria, tetanus, pertussis, hepatitis B (except the birth dose of Hep B vaccine) or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
5. For Stage 2 only: Previous booster dose vaccination against diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
6. Past or current receipt of immunoglobulins, blood or blood-derived products or planned administration during the trial.
7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, or long-term systemic corticosteroid therapy.
8. History of diphtheria, tetanus, pertussis, hepatitis B, or Haemophilus influenza type b infections.
9. Known personal or maternal history of HIV or hepatitis B seropositivity.
10. Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances.
11. Known thrombocytopenia.
12. Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contradicting intramuscular vaccination.
13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness on the day of inclusion.
15. Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
16. Subject with definite seizure disorder and getting anticonvulsant therapy. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity in terms of Hep B seroprotection rate and pertussis immune responses |
Baseline; 28 days after Dose-3 in infants |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Safety after each and after any study vaccine dose, as applicable. |
Immediate adverse events within 30 min, Solicited reactions within 7 days and Unsolicited Events within 28 days of vaccination. |
| Immunogenicity in terms of Seroprotection/seroresponse rates/GMCs for D,T,wP,HepB and Hib antigens |
Baseline; 28 days post Dose-3 in infants and 28 days after single dose in toddlers |
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Target Sample Size
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Total Sample Size="460"
Sample Size from India="460"
Final Enrollment numbers achieved (Total)= "460"
Final Enrollment numbers achieved (India)="460" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
28/12/2018 |
| Date of Study Completion (India) |
13/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/02/2021 |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This will be a multi-center, randomized, active controlled, two arm, observer blind study in 460 infants followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed vaccine formulation of SHAN 5® at 6-8, 10-12 and 14-16 weeks of age. Followed by single arm, open label study in the subjects upon attaining 12-24 months of age followed up for safety and immunogenicity for 28 days after administration of single booster dose of the investigational vaccine formulation of SHAN 5®. |