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CTRI Number  CTRI/2019/04/018677 [Registered on: 22/04/2019] Trial Registered Prospectively
Last Modified On: 17/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study To Evaluate Safety and Immunogenicity Of Pneumococcal Vaccine of Panacea Biotec In Healthy Toddlers. 
Scientific Title of Study   An Open Labeled, Single Arm (Non-Comparative), Prospective Phase I Clinical Study To Evaluate The Safety, Tolerability And Immunogenicity Of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11-Valent Of Panacea Biotec Ltd. In Healthy 12-23 Months Old PCV- naïve Toddlers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PBL/CR/2018/01/CT/NUCO11 version 2 dated 04 Sep 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalitendu Mohanty  
Designation  Sr. GM 
Affiliation  Panacea Biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,

South West
DELHI
110044
India 
Phone  011-41679000   
Fax  011-41578085   
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lalitendu Mohanty  
Designation  Sr. GM 
Affiliation  Panacea Biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,


DELHI
110044
India 
Phone  011-41679000   
Fax  011-41578085   
Email  lalitendumohanty@panaceabiotec.com  
 
Details of Contact Person
Public Query  
Name  Dr Lalitendu Mohanty  
Designation  Sr. GM 
Affiliation  Panacea Biotec Ltd 
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road,


DELHI
110044
India 
Phone  011-41679000   
Fax  011-41578085   
Email  lalitendumohanty@panaceabiotec.com  
 
Source of Monetary or Material Support  
Panacea Biotec Limited B-1 Extn./G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi - 110 044 
 
Primary Sponsor  
Name  Panacea Biotec Limited  
Address  B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N S Mahantashetti  KLES Dr. Prabhakar Kore Hospital & Medical Research   SMO office G 2 near Psychiatry ward KLES Dr Prabhakar Kore Hospital & Medical Research Centre Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA 		 7204345879

nsmahantasheeti@gmail.com 
Dr Virendra Nath Tripathi  Prakhar Hospital Pvt Ltd.  Clinical Research Room, 4th floor, Prakhar Hospital Pvt.Ltd, 8/219, Arya Nagar, Kanpur, Uttar Pradesh-208002
Kanpur Nagar
UTTAR PRADESH 		 9415050777

drvntripatthi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics committee of Prakhar Hospital  Approved 
Institutional Ethics Committee KLES Dr. Prabhakar Kore Hospital & Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Protection against invasive pneumococcal disease  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  NucoVac®-11; Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11 Valent (1, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) of Panacea Biotec Ltd.  2 doses of test vaccine will be administered with a gap of 60 days. 0.5 ml per dose will be administered by deep intramuscular injection in the antero-lateral aspect of thigh. 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  23.00 Month(s)
Gender  Both 
Details  1. Healthy PCV-naïve toddler between 12-23 months of age (Both Inclusive) on the day of enrollment. PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
2. Toddlers whose parents/LAR willing to audio visual consent process and give written informed consent prior to the study entry.
3. Toddlers with an up-to-date minimal vaccination status for their age at the time of enrollment (“minimal”defined as single dose of BCG, 3 doses of Polio vaccine, DPT, Hepatitis B and single dose of Measles at the time of enrollment).
4. Toddlers with good health as determined by:
4.1 Medical history
4.2 Physical examination
4.3 Clinical judgment of the investigator
5. Toddlers judged to be able to attend all scheduled study visits and to comply with trial procedures.
 
 
ExclusionCriteria 
Details  1. History of culture-proven invasive disease caused by S. pneumoniae.
2. Toddler who have received any pneumococcal vaccine prior to enrollment.
3. History of Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C in toddler.
4. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drug within the 6 months prior to administration of the study vaccine. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day or equivalent.
5. Administration of immunoglobulins and/or any blood products
during the period starting three months before the administration of study vaccine or planned administration during the study period.
6. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
7. History of any neurological disorder, meningitis or seizures.
8. Axillary temperature ≥ 38.0°C in past 3 days.
9. Any evidence of acute illness or infection requiring systemic antibiotic therapy within past 30 days before the administration of study vaccine or planned use during the study period.
10. Planned or elective surgery during the course of the study.
11. Toddler with history of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component.
12. Toddler with any serious chronic disease or with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives or compromise the safety of the subject.
13. The parents or LAR are unwilling or unable to give written informed consent to participate in the study
14. Toddlers whose families are planning to leave the area of the study site before the end of the study period.
15. Todllers who have participated in another trial or received an investigational agent within 30 days of enrolment.
Exclusion criteria for the second dose
1. Hypersensitivity to vaccine within 48 hours of administration of previous vaccine dose
2. Seizures
3. Encephalopathy
4. Axillary temperature of > 40oC within 48 hours of previous vaccine dose
5. Inconsolable persisting crying (defined as > 3 hours within 48 hours of previous vaccination),
6. Generalized cyanosis within 48 hours of previous vaccine dose
7. Any serious reaction after previous dose which can compromise the safety of the subject if continued in the trial.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Incidence, intensity and relationship to vaccination of solicited(local and systemic ) adverse reactions during the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination
2. Incidence, intensity and relationship to vaccination of unsolicited adverse reactions during the entire study period.
3. Incidence, intensity and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period.
 		 1. During the 30 minutes of post vaccination observation period and for 7 consecutive days (day 0 to 6) after each vaccination
2. During the entire study period.
3. During the entire study period.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of subjects with anti-pneumococcal polysaccharide conjugate (PnCPS) IgG antibody concentration 0.35 μg/ml (as measured by ELISA) against each of the vaccine serotypes at day 30 post 2nd dose of test vaccine.
2. Anti-PnCPS IgG ELISA geometric mean titre (GMT) against each of the vaccine serotypes with their two sided 95% Cls at day 30 post 2nd dose of test vaccine.
 		 Day 0 before vaccination and on day 90 in follow up visit.
Results of the secondary outcome shall be come after 4 months of completion of the trial 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   24/04/2019 
Date of Study Completion (India) 10/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is an open label phase I study to demonstrate safety, tolerability and immunogenicity of Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 11 valent. After obtaining the informed consent from the subject’ parent or LAR, followed by preliminary screening as per inclusion and exclusion criteria  a total of 30 healthy  PCV-naïve toddlers (in the age group of 12-23 months) will be enrolled into the study. Enrolled subjects will receive intramuscularly 0.5 ml of test vaccine.

There will be a total of 3 visits during the entire study duration. For all subjects, the study period will be divided into 3 visits: Day 0 (Visit 1), Day 60 (Visit 2) and Day 90 (Visit 3). Subject will receive two doses of vaccine with a 60 day (-3/+7) interval between doses. Local and systemic solicited reactions will be observed on each vaccination day (up to 30 minutes post vaccination) and on 7 subsequent days (day 0-6) post vaccination. Local & systemic solicited reactions will be recorded in subject diary card. Adverse events will be monitored during the total study period of 90 days. Blood samples (For immunogenicity assessment) will be obtained from subjects at visit 1(before first vaccination) and at visit 3 (Day 90; Follow up visit). 

The study will be conducted according to schedule Y, declaration of Helsinki and Good Clinical Practices.

 
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