| CTRI Number |
CTRI/2017/11/010387 [Registered on: 06/11/2017] Trial Registered Prospectively |
| Last Modified On: |
25/11/2019 |
| 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 Biological Es 14-valent pneumococcal polysaccharide conjugate vaccine in 12-23 months old healthy Indian toddlers. |
|
Scientific Title of Study
|
An open label parallel randomised Phase-II comparative study to evaluate safety, tolerability and immunogenicity of two intramuscular doses of 14-valent pneumococcal polysaccharide conjugate vaccine administered 2 months apart to 12-23 month-old healthy Indian PCV-naïve toddlers. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT044/PCV-Phase-II/CTP-01 version :01 dated:30.08.17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Thuluva |
| Designation |
Vice President- Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Biological E.Limited,
18/1&3, Azamabad, Hyderabad,
Telangana
India
18/1&3, Azamabad, Hyderabad,
Telangana
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
04067388087 |
| Fax |
04027675309 |
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTSA Kishore |
| Designation |
Associate Vice President- Clinical Affairs & Pharmacovigilance |
| Affiliation |
Biological E.Limited |
| Address |
Biological E.Limited,
18/1&3, Azamabad, Hyderabad,
Telangana
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
4030214046 |
| Fax |
04027675309 |
| Email |
kishore.turaga@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTSA Kishore |
| Designation |
Associate Vice President- Clinical Affairs & Pharmacovigilance |
| Affiliation |
Biological E.Limited |
| Address |
Biological E.Limited,
18/1&3, Azamabad, Hyderabad,
Telangana
India
Hyderabad
ANDHRA PRADESH
500020
India |
| Phone |
4030214046 |
| Fax |
04027675309 |
| Email |
kishore.turaga@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, Telangana, India 500020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Prashanth |
Cheluvamba Hospital |
Ground floor, Dept. of Paediatrics, Cheluvamba Hospital, Mysore Medical College & Research Institute, Irwin Road, Mysore – 570001.
Mysore
KARNATAKA |
08105028742
drsp2013@rediffmail.com |
| Dr P Venugopal |
King George Hospital |
1st Floor,Dept. of Paediatrics,Collectorate Junction, Maharanipeta Visakhapatnam – 530002.
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH |
09848027203
fbnc.amc@gmail.com |
| Dr G Bala Kishor |
St. Theresa’s Hospital |
Dept. of Pediatrics, Ist floor, PRD block, Sanathnagar,Hyderabad, 500018-Telangana- India
Hyderabad
ANDHRA PRADESH |
09949046236
baki2004@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee, St. Theresa’s Hospital |
Approved |
| Institutional Ethics Committee- King George Hospital |
Approved |
| Institutional Ethics Committee- Mysore Medical college & Research Institute- Cheluvamba Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive protection against Pneumococcal disease caused by the vaccine serotypes. |
| Patients |
(1) ICD-10 Condition: Z23||Encounter for immunization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pfizer’s 13-valent Pneumococcal Polysaccharide Conjugate Vaccine-Prevenar13® |
1. Dose:0.5 mL two dose 2. Frequency: two doses administered 2 months apart 3. Route of administration: Intramuscular injection in in the anterolateral aspect of thigh, Alternatively, deltoid muscle can be used in those if the muscle mass is adequate. 4.Total duration of therapy: 90 days |
| Intervention |
Pneumococcal polysaccharide Conjugate Vaccine (Adsorbed) (14 Valent)- Single Human dose-0.5mL |
1. Dose:0.5 mL two dose 2. Frequency: two doses administered 2 months apart 3. Route of administration: Intramuscular injection in in the anterolateral aspect of thigh, Alternatively, deltoid muscle can be used in those if the muscle mass is adequate. 4.Total duration of therapy: 90 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Month(s) |
| Age To |
23.00 Month(s) |
| Gender |
Both |
| Details |
1.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 land line or mobile).
2.Written or thumb printed informed consent (including audio-visual recording of consent process) obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
3.A male or female PCV-naïve child (toddler) between and including 12 and 23 months of age at the time of first dose vaccination. PCV-naïve toddlers are those who have not been previously vaccinated with any licensed or investigational pneumococcal vaccine.
4.Toddlers with an up-to-date minimal vaccination status for their age at the time of enrolment (“minimal†defined as single dose of BCG, 3 doses of OPV, DPT, and Hepatitis B, and single dose of Measles at the time of enrolment).
5.Healthy subjects as established by medical history and clinical examination before entering into the study.
6.Subjects that are negative for Human Immunodeficiency Virus (HIV), hepatitis B and hepatitis C to the best of parent(s)/LAR(s) knowledge
|
|
| ExclusionCriteria |
| Details |
1.Child in care, defined as a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
2.Previous history of pneumococcal vaccination;
3.Evidence of previous or intercurrent Streptococcus pneumoniae infection.
4.Use of any investigational or non-registered product (drug or vaccine) other than the study 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.
5. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
6.Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone  0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
7.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).
8.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
9.Family history of congenital or hereditary immunodeficiency.
10.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.
11.Major congenital defects as judged by the PI.
12.History of any neurological disorders, meningitis or seizures.
13.Toddler who has had 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.
14.Toddler 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).
15.Acute disease and/or fever at the time of vaccination.
o Fever is defined as the endogenous elevation of at least one measured body temperature of ≥ 38◦C (≥ 100.4◦F).8
16.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination.
17.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.
18. Administration of long-acting immune-modifying drugs at any time during the study period.
19. Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
- collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination,
- convulsions with or without fever, occurring within three days of vaccination.
- Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of vaccination.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety:
1.Proportion of subjects with solicited adverse reactions.
2.Proportion of subjects with unsolicited local and systemic adverse events (AEs).
3.Serious adverse events (SAEs), if any, |
1.during first 60 minutes of post vaccination observation period and for 7 consecutive days (Day 0-6).
2.during the total study period of 90 days.
3.during the total study period of 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Immunogenicity:
1.Anti-PnCPS IgG elisa Geometric Mean Titre (GMT) against each of the vaccine serotypes with their two sided 95% CIs.
2.Anti-PnCPS IgG elisa Geometric Mean Fold Rise (GMFR) against each of the vaccine serotype.
3.Proportion of subjects achieving ≥2 fold and ≥4 fold rise in anti-PnCPS IgG elisa titre against each of the vaccine serotype.
4.Proportion of subjects with anti-PnCPS IgG concentration ≥ 0.35 μg/ml (as measured by ELISA). |
1.at day 30 post 2nd dose of vaccination in both groups.
2.at day 30 post 2nd dose of vaccination in both groups.
3.at 30 days post 2nd dose in both groups.
4.against each of the vaccine serotypes in both the groups. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2017 |
| Date of Study Completion (India) |
16/04/2018 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label parallel randomised active control, two-arm phase-II comparative study to evaluate safety, tolerability and immunogenicity of two 0.5mL intramuscular doses of 14-valent pneumococcal polysaccharide conjugate vaccine administered 2 months apart to 12-23 month-old healthy Indian PCV-naïve toddlers. A total of 120 healthy Indian PCV-naïve toddlers will be equally randomised to one of the treatment arms (test and control groups) based on the screening and enrolment criteria set in the protocol. Each subject will receive a single 0.5 mL dose of the study vaccine intramuscularly i.e., Biological E’s 14-valent PCV without preservative or Pfizer’s Prevenar13® vaccine, based on the treatment groups to which they are randomised for assessing the safety, tolerability & Immunogenicity.
Only optimal quantity of venous blood sample approximately 3.5 mL for serotype specific anti-PnCPS IgG antibody assay will be drawn twice during the study period, once at screening and again 30 days post second dose.
The study will be conducted in compliance with schedule Y, ICH and Indian good clinical practice guidelines in force. |