| CTRI Number |
CTRI/2013/05/003711 [Registered on: 31/05/2013] Trial Registered Prospectively |
| Last Modified On: |
28/06/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A single center, open label,comparitive study to evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults |
|
Scientific Title of Study
|
A Randomized, Open Label, Comparative, Single Dose Phase I/II Study to Evaluate the Safety, Tolerability and Immunogenicity of two Formulations (with and without preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults |
| Trial Acronym |
NUCOVAC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/CR/2012/03/CT/NUCOV version no 02 dated 26 march 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arani Chatterjee |
| Designation |
senior vice president-clinical research |
| Affiliation |
Panacea biotec ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
1141679000 |
| Fax |
1141679070 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arani Chatterjee |
| Designation |
senior vice president-clinical research |
| Affiliation |
Panacea biotec ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
1141679000 |
| Fax |
1141679070 |
| Email |
aranichatterjee@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Arani Chatterjee |
| Designation |
senior vice president-clinical research |
| Affiliation |
Panacea biotec ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road
New Delhi
DELHI
110044
India |
| Phone |
1141679000 |
| Fax |
1141679070 |
| Email |
aranichatterjee@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Ltd,New Delhi |
|
|
Primary Sponsor
|
| Name |
PANACEA BIOTEC LIMITED |
| Address |
Panacea Biotec Limited, B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road, New Delhi-110044 Ph.: +91-11-41678000, 41679000 Extn. 2510 Fax: +91-11-41578085 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVVSatyanarayana |
King George Hospital |
King George Hospital,
Visakhapatnam- 530002,
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
09848022894
Satyanarayana.vempolu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King George Hospital, Visakhapatnam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pneumonia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pneumococcal Polysaccharide Conjugate Vaccine with and without preservative. |
0.5 ml, Intramuscular, single dose Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed), 10-valent (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) with or without Preservative |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male or female Subjects aged 18 to 65 years of age.
2.Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening.
3.Subject willing to give written informed consent and fulfill all study requirements
4.If female subjects and child bearing potential but practicing acceptable method of contraception or surgically sterile.
Acceptable methods of contraception are
Intra-uterine contraceptive device without hormone release system placed at least 4weeks prior to study drug administration
Effective method of barrier contraception like Condom or diaphragm with spermicidal gel/foam/film/cream/suppository |
|
| ExclusionCriteria |
| Details |
1. History of previous vaccination against S. pneumoniae (in the previous 5 years).
2. History of pneumococcal infection (confirmed either clinically, serologically, or microbiologically) within 5 years
3. Bleeding disorder, including thrombocytopenia contraindicating IM vaccination, or receipt of anticoagulants in the 3 weeks preceding inclusion.
4. Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
5. Known Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine with similar composition.
6. Known history of administration of blood or blood-derived products in the past 3 months.
7. Chronic administration (defined as more than 14 days) of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, lmmunosuppressants or other immune-modifying drugs in past or at any time during the study.
8. Febrile illness (temperature ≥38.0°C or 100.4 °F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
9. Receipt of oral or injected antibiotic therapy within 72 hours prior to any blood draw (for immunogenicity assessment).
10. Use of any investigational drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
11. Presence of chronic cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, cancer or autoimmune disease under treatment such as would endanger the volunteer or is likely to result in non conformance to the protocol.
12. Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures
13. History or presence of significant asthma, urticaria or other allergic reactions.
14. History or presence of significant smoking (more than 10 cigarettes or beedis/day).
15. Pregnant and/ or lactating mothers in case of female subjects.
16. Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C seropositivity
17. Participation in a drug research study within past 3 months.
18. Planned participation in another clinical trial during the trial period.
19. Subjects planning to leave the area of study before completion of the study.
|
|
|
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 tolerability Incidence intensity causality and relationship to vaccination of solicited adverse events |
solicited adverse events local and systemic during the 7 day follow-up period day 0 to 7 after vaccination, 4 weeks follow-up period after vaccination
Incidence, intensity, causality and relationship to vaccination of Serious Adverse Events (SAEs) during the entire study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity- serotype specific Anti Pneumococcal IgG as determined by ELISA and OPA |
Seroprotection against Pneumococcal Serotypes at 28+3 days followup post vaccination |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
04/06/2013 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects in each group will receive single dose of one of the two (with or without preservative) test vaccines.Subjects will be administered with the study vaccines on Day 0 and will be followed up to Day 28. A blood sample will be collected on Day 0 (Pre-dose), Day 28 (Post dose), for immunogenicity parameters (Anti-Pneumococcal antibodies). Blood and urine sampling for screening and safety analysis will be done for all subjects at screening and Day 28.The aim of our present study is to evaluate the safety, tolerability and immunogenicity of two formulation (with and withought preservative) of 10-valent Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) NUCOVAC® in Healthy Adults |