| CTRI Number |
CTRI/2024/11/076260 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| 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 trial to assess the safety and overall immune response of pneumococcal polysaccharide conjugate vaccine in 6-8 weeks old infants. |
|
Scientific Title of Study
|
An open label randomised Phase-II study to evaluate safety, reactogenicity and immunogenicity of Biological E’s 24-valent pneumococcal polysaccharide conjugate vaccine when administered to 6-8 weeks old healthy Indian infants in 6-10-14 weeks dosing schedule. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT085/PCV-Phase-II/CTP-02Version :2.0 dated:02.04.24 |
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
Hyderabad
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 |
Biological E.Limited |
| Address |
18/1&3, Azamabad, Hyderabad - 500020, Telangana, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| 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
Faridabad
HARYANA |
07042918222
drpandeyak@yahoo.co.in |
| Dr Jai Prakash Narayan |
JLN Medical College |
Department of Pediatrics, JLN Medical College ,2nd Floor, Kala Bagh,305001
Ajmer
RAJASTHAN |
09314294402
narayan_jaiprakash@yahoo.co.in |
| Dr BS Chakravarthy |
King George Hospital |
Dept of Paediatrics, King George Hospital, Collectorate junction, 1st floor, Maharanipeta- 530002
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
Belgaum
KARNATAKA |
09448157237
niranjanakle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| IEC King George hospital |
Approved |
| Institutional Ethics Committee - Jawahar Lal Nehru Medical College |
Approved |
| Institutional Ethics Committee for ESIC |
Approved |
| Institutional Ethics Committee, KLE University Dr.PK Hospital and MRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive protection against Pneumococcal diseases. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BE’s Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent) (Pneubevax) |
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 |
Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) (24 Valent) |
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. Healthy pneumococcal conjugate vaccine-naïve (PCV-naive) infants as established by medical history and the clinical assessment before entering into the study. PCV-naïve infants are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
2. Infants between 6-8 weeks of age (42-56 days, both days inclusive) of either gender, at the time of first dose of vaccination.
3. Healthy Infants with body weight ≥ 3300 gms at the time of screening.
4. Subjects’ parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, with access to a consistent means of telephone contact, either residential landline or mobile).
5. Subject’s parent(s)/LAR(s) willing to provide written or thumb printed informed consent (including audio visual recording of consent process) prior to performing any study specific procedure
6. Infants with a minimal vaccination status for their age at the time of enrolment (“minimal†defined as single birth dose of BCG, Hepatitis B and Polio vaccine at the time of enrolment).
|
|
| ExclusionCriteria |
| Details |
1.Child in care
2. Evidence of previous Streptococcus pneumoniae infection or pneumococcal vaccination;
3. Use of any investigational or non-registered product (drug or 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 other than the study vaccine;
4. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe (eg., coagulation abnormalities).
5. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs or any blood products during the period starting 30 days prior to the proposed first vaccine dose or planned administration of the same during the study period.
6. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
7. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
8. Family history of congenital or hereditary immunodeficiency.
9. 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.
10. History of any neurological disorders, meningitis or seizures.
11. Infant who has had a family history of a sibling die of sudden infant death syndrome (SIDS) or die suddenly and without apparent other cause or preceding illness in the first year of life.
12. 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).
13. Acute disease and/or fever at the time of vaccination.
14. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination and Principal investigator judgement.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of subjects with solicited local and systemic adverse reactions
2.Proportion of subjects with unsolicited local and systemic adverse events (AEs)
3.Serious adverse events (SAEs) and medically attended adverse events (MAAE) if any |
1. during first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days (Day 0-6) thereafter
2.during the total post vaccination follow up period till day 84.
3.during the total 84 days of study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving seroconversion |
At day 84 post (28 days post third dose of the vaccination) |
| Proportion of subjects achieving ≥2-fold and ≥4-fold increase in serotype specific anti-PnCPS IgG antibody titre |
At day 84 post (28 days post third dose of the vaccination) |
| Geometric mean titre (GMT) of serotype specific anti-PnCPS IgG antibodies |
At day 84 post (28 days post third dose of the vaccination) |
| Geometric Mean Fold Rise (GMFR) in serotype specific anti-PnCPS IgG titres |
At day 84 post (28 days post third dose of the vaccination) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
29/11/2024 |
| 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)
|
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
|
An
open label randomised Phase-II comparative study to evaluate safety,
reactogenicity and immunogenicity of intramuscular dose of Biological E’s
24-valent pneumococcal polysaccharide conjugate (test) vaccine in 6-8 weeks old
healthy infants administered in 6-10-14 weeks dosing schedule in comparison to
licensed comparator vaccine, BE’s PCV-14 (control).
A total of 120
subjects will be equally randomised to one of the two treatment arms (test and
control groups) based on the screening and enrolment criteria set in the
protocol. Each subject will be administered a 0.5 mL dose of the study vaccine
intramuscularly i.e., BE’s 24-valent PCV (n=60) or BE’s PCV-14 vaccine (n=60)
based on the treatment group to which they are assigned in 6-10-14 weeks dosing
schedule.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. |