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CTRI Number  CTRI/2020/09/027553 [Registered on: 02/09/2020] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to check safety and immuno response of combination vaccine in children. 
Scientific Title of Study   A phase II and III multicentre randomized open label active controlled study to assess the immunogenicity and safety of DTaPIPVHib vaccine manufactured by Serum Institute of India Pvt Ltd in comparison with Pentaxim in Indian toddlers and infants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SII-aPENTA/IN-02 Version 2.0 dated 06.Feb.2020   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Details of Contact Person
Public Query  
Name  Dr Hitt Sharma 
Designation  Additional Medical Director 
Affiliation  Serum Institute Of India Pvt. Ltd. 
Address  Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India Pune

Pune
MAHARASHTRA
411028
India 
Phone  02026602451  
Fax    
Email  drhjs@seruminstitute.com  
 
Source of Monetary or Material Support  
Serum Institute of India Pvt Ltd 
 
Primary Sponsor  
Name  Serum Institute of India Pvt Ltd 
Address  212/2 Hadapsar,Pune-411028 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhaskar Jedhe deshmukh   Baramati Hospital  Behind Kavivarya Moropant Natyamandir, Ring Road, Baramati, 413102, Maharashtra
Pune
MAHARASHTRA 		 9822402772

bhaskar.jedhe@gmail.com 
Dr Jitendra Oswal  Bharti Vidyapeeth Deemed University Medical college and Hospital  Department of pediatrics, Pune-Satara Road, Katraj Dhankawdi, Pune-411043
Pune
MAHARASHTRA 		 9822296180

researchpedpune@gmail.com 
Dr Avinash Gawande  Government Medical College and Hospital   Medical College Square Road, Nagpur-440003
Nagpur
MAHARASHTRA 		 9822224020

dravinashgawande@gmail.com 
Dr Nishikant Tiple  Government Medical College and Hospital   District General Hospital, Jatpura Gate Road, Chandrapur- 442402
Chandrapur
MAHARASHTRA 		 07350689826

nishikant_tiple@yahoo.co.in 
Dr Apurba Ghosh  Institute of Child Health  Institute of Child Health, 11,Dr. Biresh Guha Street, Kolkata,700017
Kolkata
WEST BENGAL 		 9830052887

apurbaghosh@yahoo.com 
Dr M D Ravi  JSS Hospital  Mahatma Gandhi Road,Mysuru- 570004
Mysore
KARNATAKA 		 9850559983

ravimdped@gmail.com 
Dr Anand Kawade  KEM Hospital Research Centre  Vadu Rural Health Program, Village-Vadu(Budruk), Tal-Shirur, Pune-412216
Pune
MAHARASHTRA 		 9552588996

anand.kawade@kemhrcvadu.org 
Dr N S Mahantshetti  KLEs Dr Prabhakar Kore Hospital and Medical research Centre  KLEs Dr Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgavi-590010,
Belgaum
KARNATAKA 		 9448157237

niranjanasn@yahoo.com 
Dr Swapnil Janbandhu  LifePoint Multispeciality Hospital  145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad Pune-411057
Pune
MAHARASHTRA 		 9867791280

janbandhu.swapnil117@gmail.com 
Dr N Ravi Kumar   Niloufer Hospital   Red Hills, Lakdikapool, Hyderabad-500004.
Hyderabad
TELANGANA 		 949019293

ravik1961@yahoo.com 
Dr Deepali Ambike  Postgraduate Institute, Yashwantrao Chavan Memorial Hospital  2nd Floor, Postgraduate institute, Yaswantrao Chavan memorial Hospital, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune-411018
Pune
MAHARASHTRA 		 9373992972

ambikedeepa@gmail.com 
Dr Dinesh Kaul  Sir Ganga Ram Hospital  Old Rajinder Nagar,Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI 		 9811211205

docdineshkaul@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Comittee of Baramati Hospital Pvt. Ltd  Approved 
Institutional Ethics Committee Osmania Medical College Osmania Medical College,Koti, Hyderabad   Approved 
Institutional Ethics Committee, Bharati Vidyapeeth Deemed University, Pune  Approved 
Institutional Ethics Committee, JSS Medical College and Hospital, Mysore  Approved 
Institutional Ethics Committee, King Edward Memorial Hospital Research Centre Pune  Approved 
Institutional Ethics Committee, KLE University, JN Medical college, Nehru Nagar, Belgavi  Approved 
Institutional Ethics Committee, Yashwantrao Chavan Memorial Hospital, Pune  Approved 
Institutional Ethics Committee,, Institute of Child Health, Kolkata  Approved 
Institutional Ethics Committee,GMC Nagpur   Approved 
Lifepoint ResearchEthics Committee  Approved 
lnstitutional Ethics Committee GMC Chandrapur  Submittted/Under Review 
Sir Ganga Ram Hospital Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z23||Encounter for immunization,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DTaPIPVHib vaccine by SIIPL  Dose:0.5ml, Single dose (at 15 to 18 months of age) in Toddlers and 3 dose series (at 6-10-14 weeks of age) in infants. Route:Intramuscular 
Comparator Agent  Pentaxim by Sanofi Pasteur  Dose:0.5ml, Single dose (at 15 to 18 months of age) in Toddlers and 3 dose series (at 6-10-14 weeks of age) in infants. Route:Intramuscular 
 
Inclusion Criteria  
Age From  42.00 Day(s)
Age To  18.00 Month(s)
Gender  Both 
Details  For both Part I and Part II:
1. Subject of either sex with a good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
2. Informed consent form signed by at least one parent or legally acceptable representative.
3. Subject and parent/legally acceptable representative able to attend all scheduled visits and willing to comply with all study procedures during the entire duration of the trial.

Additional inclusion criteria for Part I only:
4a. Subject is between 15-18 months of age at the time of vaccination.
5a. Subject who has completed primary immunization series against Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and poliomyelitis (OPV and/or IPV) and has not received the booster dose scheduled at 15-18 months of age.
6a. The weight-for-length z-score for the subject is greater than or equal to -2 SD.

Additional inclusion criteria for Part II only:
4b. Subject aged 6-8 weeks (42-56 days, both inclusive) at the time of first vaccination.
5b. Subject born at full term pregnancy (greater than or equal to 37 weeks) with a birth weight greater than or equal to 2.5 kg.
6b. Subject who have received the birth dose of OPV and BCG vaccine at least four weeks before the first trial vaccination.
 
 
ExclusionCriteria 
Details  For both Part I and Part II:
1. History of Diphtheria/Tetanus/Pertussis/Haemophilus influenzae type b/Poliomyelitis, Infection(s).
2. Presence of evolving or changing neurological disorder or subject with a history of seizures and/or encephalopathy.
3. Fever greater than or equal to 38°C/100.4°F in the past 7 days and/or any evidence of acute illness or infection within the past 7 days.
4. Planned surgery during the course of the study.
5. History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or constituent of study vaccine.
6. History of any clinically significant chronic disease such that in the opinion of the investigator, it might interfere with the evaluation of the study objectives.
7. History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
8. Known thrombocytopenia or a bleeding disorder.
9. Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
10. Subject whose families are planning to leave the area of the study site before the end of the study period.
11. Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.

Additional exclusion criteria for Part I only:
12a. Receipt of blood or blood-derived products or immunoglobulins in the past 3 months, current or planned administration during the trial.
13a. Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or received immunosuppressive therapy within 6 months prior to study entry
14a. Administration of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the trial vaccination or planned receipt of any non study vaccine during the study period.

Additional exclusion criteria for Part II only:
12b. Receipt of any vaccine (except OPV during immunization campaign) in the 4 weeks preceding the first dose of trial vaccine.
13b. Previous or planned vaccination against diphtheria, tetanus, pertussis, poliomyelitis (except OPV) or Haemophilus influenzae type b infection apart from trial vaccines during the study period.
14b. Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response.
15b. Subject with a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or received immunosuppressive therapy prior to study entry
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
For Part I:
1. Occurrence of local and systemic solicited and unsolicited adverse events.
For Part II :
1. Percentage of infants achieving seroprotection/seroconversion after 3 dose primary vaccination
series. 		 For Part I:
1. Any adverse event (AE) within 30 minutes, Solicited reactions up to 7 days and Unsolicited Events up to 28 days of vaccination and serious adverse event (SAE) during the study period
For Part II :
1. 28 days post completion of a 3 dose primary vaccination series. 
 
Secondary Outcome  
Outcome  TimePoints 
For Part I : Immunogenicity (Seroprotection/seroresponse rates and GMCs/GMTs)
For Part II : 1. Safety after each study vaccination 2. Immunogenicity w.r.t. Geometric Mean Titre/Concentration (GMT/GMC)  		 For Part I : 28 days following vaccination
For Part II : 1. 28 days following each
vaccination. 2. 28 days post completion of 3
dose primary vaccination series 
 
Target Sample Size   Total Sample Size="898"
Sample Size from India="898" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="898" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   07/09/2020 
Date of Study Completion (India) 09/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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)?  

Response - NO
Brief Summary  
This is an open label, randomized, active-controlled, multi-centric study to be conducted in two parts in healthy Indian toddlers and infants to assess the immunogenicity and safety of SIIPL DTaPIPVHib vaccine in comparison with Pentaxim.  
In Part I of the study, 112 toddlers, aged 15-18 months will be randomized to receive a booster dose of SIIPL DTaPIPVHib vaccine or Pentaxim. Toddlers will be followed up for 28 days post-vaccination for safety and immunogenicity. In Part II of the study, 786 infants aged 6-8 weeks will be randomized  to receive a 3-dose primary vaccination series of  DTaPIPVHib vaccine or the comparator viz., Pentaxim.
 
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