CTRI/2014/05/004608 [Registered on: 20/05/2014] Trial Registered Prospectively
Last Modified On:
11/04/2016
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Other
Public Title of Study
Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India
Scientific Title of Study
A phase 4, open-label, single-arm, multicenter study to
describe the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India
Trial Acronym
N/A
Secondary IDs if Any
Secondary ID
Identifier
B1851140, Amendment 01 dated 24 Jun 2013
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Swapnali Raut
Designation
Director Compliance Oversight
Affiliation
Wyeth Ltd. (Subsidiary of Pfizer inc.)
Address
Pfizer Limited
Pfizer Centre, Patel Estate
SV Road, Jogeshwari West
Mumbai 400102,Maharashtra, India Wyeth Ltd. (Subsidiary of Pfizer inc.)
Level 6, Platina, Plot No.C-59, ‘G’ Block, Bandra-Kurla Complex,Bandra (East), Mumbai 400 051
Mumbai MAHARASHTRA 400102 India
Phone
912266932442
Fax
912226788292
Email
Swapnali.raut@pfizer.com
Details of Contact Person Scientific Query
Name
Swapnali Raut
Designation
Director Compliance Oversight
Affiliation
Wyeth Ltd. (Subsidiary of Pfizer inc.)
Address
Pfizer Limited
Pfizer Centre, Patel Estate
SV Road, Jogeshwari West
Mumbai 400102,Maharashtra, India Wyeth Ltd. (Subsidiary of Pfizer inc.)
Level 6, Platina, Plot No.C-59, ‘G’ Block, Bandra-Kurla Complex,Bandra (East), Mumbai 400 051
Mumbai MAHARASHTRA 400102 India
Phone
912266932442
Fax
912226788292
Email
Swapnali.raut@pfizer.com
Details of Contact Person Public Query
Name
Swapnali Raut
Designation
Director Compliance Oversight
Affiliation
Wyeth Ltd. (Subsidiary of Pfizer inc.)
Address
Pfizer Limited
Pfizer Centre, Patel Estate
SV Road, Jogeshwari West
Mumbai 400102,Maharashtra, India Wyeth Ltd. (Subsidiary of Pfizer inc.)
Level 6, Platina, Plot No.C-59, ‘G’ Block, Bandra-Kurla Complex,Bandra (East), Mumbai 400 051
Mumbai MAHARASHTRA 400102 India
The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400051, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 25
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Bhagirathi Solanki
B. J. Medical College & Civil Hospital
Department of Internal Medicine, B. J. Medical College & Civil Hospital, Asarwa, Ahmedabad - 380016, Gujarat, India Ahmadabad GUJARAT
09904025799 07922683421 drbhagirath@yahoo.co.in
Dr Sanjay Lalwani
Bharati Vidyapeeth Deemed University Medical College Bharati Hospital & Research Centre
Bharati Vidyapeeth Deemed University Medical College & Bharati Hospital & Research Centre, Department of Pediatrics, Katraj - Dhankawadi, Pune – 411043, Maharashtra, India Pune MAHARASHTRA
Bhatia Hospital,Dept of General Medicine
Tukaram Javji Road, Tardeo, Mumbai - 400007 Mumbai MAHARASHTRA
09322589110 02266660630 drpratit@gmail.com
Dr Krishnamurthy Balasundaram
Cheluvamba Hospital
Cheluvamba Hospital, Department of Pediatrics,
Irwin Road,
Mysore- 570001
Karnataka, India Mysore KARNATAKA
919448057007 08212427951 bkm876@gmail.com
Dr Manoj Chopda
Chopda Medicare & Research Centre Pvt. Ltd
Chopda Medicare & Research Centre Pvt. Ltd,Department of Cardiology, Magnum Heart Institute,3/5,Patil Lane no 1,Laxmi Nagar,Near K.B.H Vidyalaya,Canada Corner,Nasik – 422005, Maharashtra, India Nashik MAHARASHTRA
09823021613 02532316204 rush_manoj@yahoo.com
Dr Devasahayam Jesudas Christopher
Christian Medical College
Department of Pulmonary Medicine, Christian Medical College, P.O. Box 3, IDA Scudder Road, Vellore – 632004, Tamil Nadu, India Vellore TAMIL NADU
09443306573 04162211570 pulmedcmc@gmail.com
Dr Leena Dhabi
Department of Medicine, AMC MET Medical College and Sheth L. G. General Hospital
Department of Medicine, AMC MET Medical College and Sheth L. G. General Hospital, Maninagar. Ahmedabad - 380008. Gujarat, India Ahmadabad GUJARAT
09427609717 07925464653 leenadabhilg@gmail.com
Dr Pradyut Waghray
Eesha Multi Speciality Hospital
Room No. 403, Eesha Multi Speciality Hospital, #6-3-1106/1/A, Adjacent to HSBC Bank, Raj Bhavan Road, Somajiguda, Hyderabad - 500062, Andhra Pradesh, India Hyderabad ANDHRA PRADESH
09246531036 04023405070 kimschest@rediffmail.com
Dr Rajesh Swarnakar
Getwell Hospital and Research Institute
Getwell Hospital and Research Institute, Dept of Respiratory Medicine,
20/1, Dr. Khare Marg, Dhantoli, Nagpur - 440012, Maharashtra, India Nagpur MAHARASHTRA
K. G. Hospital and Post Graduate Medical Institute
K. G. Hospital and Post Graduate Medical Institute,Dept of Diabetalogy, Room No 5, No 5, Arts College Road, Coimbatore - 641018, Tamil Nadu, India Coimbatore TAMIL NADU
09443170088 04222218721 drgirimd@yahoo.com
Dr Amit Sapru
KEM Hospital Research Centre
Department of Pediatrics, KEM Hospital Research Centre,
Sardar Moodliar Road, 489 Rasta Peth, Pune-411011,
Maharashtra, India Pune MAHARASHTRA
919822842094 02026125603 avsapru@gmail.com
Dr Nallibabu Vijayakumar
King George Hospital
Department of Medicine, Andhra Medical College, Maharanipeta, Visakhapatanam – 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
09177197676 08912782211 drnbvk@gmail.com
Dr Arun Narayan
M. S. Ramaiah Medical College and Hospitals
Department or Medicine, M. S. Ramaiah Medical College and Hospitals, New BEL
Road, MSRIT Post Bangalore – 560054, Karnataka, India
Bangalore KARNATAKA
919341255517 08023601983 drarunnarayan@gmail.com
Dr B J Mahendra
Mandya Institute of Medical Sciences
Department of Community Medicine, Mandya Institute of Medical Sciences, Mandya - 571401 , Karnataka, India Mandya KARNATAKA
09341234014 08232239014 tinfoilbarb123@gmail.com
Dr Girish Gokuldas Bhatia
Medipoint Hospitals Pvt Ltd
Medipoint Hospitals Pvt Ltd, 241/1, Department of Medicine, New D. P. Road, Aundh, Pune - 411007, Maharashtra, India Pune MAHARASHTRA
Department of Internal Medicine, NH Narayana Multispeciality Hospital (Unit of
Narayana Health), Narayana Hrudayalaya Pvt Ltd, Basant Health Center
Building, Site No.1, 18th Main, Opp. HSR Club, Sector III, HSR Layout, Bangalore
- 560102, Karnataka, India
Bangalore KARNATAKA
Niramaya Hospital, Survey No 4742, Department of Cardiology,Behind Jaihind Petrol Pump, Next to Chinchwad (E), Post Office, Chinchwad, Pune – 411019, Maharashtra, India Pune MAHARASHTRA
Orange City Hospital & Reseach Institute,Department of ENT, 19, Pandey Layout, Veer Sawarkar Square, Nagpur - 440015, Maharashtra, India Nagpur MAHARASHTRA
09822396797 07122221152 nandu44@gmail.com
Dr Sharad Agarkhedkar
Padmashree Dr. D. Y. Patil Medical College
Padmashree Dr. D. Y. Patil Medical College, Department of Pediatrics, Sant Tukaram Nagar, Pimpri, Pune - 411018, Maharashtra, India Pune MAHARASHTRA
919822030122 02027420439 agarkhedkar@gmail.com
Dr Dulari Gandhi
S B.K.S Medical Institute & Research Centre.
S.B.K.S Medical Institute & Research Centre, Department of Pediatrics,Sumandeep Vidyapeeth, Piparia Waghodia, Vadodara – 391760, Gujarat , India Vadodara GUJARAT
09825282700 02668-245288 djg_48@yahoo.co.in
Dr Jugal Bihari Gupta
S. R. Kalla Memorial Gastro and General Hospital
Clinical Research Department, S. R. Kalla Memorial Gastro and General Hospital, # 78-79, Dhuleshwar Garden, Behind HSBC Bank, Sardar Patel Marg, C-Scheme, Jaipur – 302001, Rajasthan, India Jaipur RAJASTHAN
09829414680 01414020622 drjbgupta@gmail.com
Dr Monica Gupta
Samvedna Hospital
Samvedna Hospital,Dept of General Medicine B 27/88G, New Colony, Ravindrapuri, Varanasi - 221005, Uttarpradesh, India Varanasi UTTAR PRADESH
09415336322 05422276001 monicag4@yahoo.com
Dr Srikanth Krishnamurthy
Sri Bala Medical Centre & Hospital
Sri Bala Medical Centre & Hospital, Department of Pulmonology,
901, Trichy Road, Ramanathapuram, Coimbatore – 641045, Tamilnadu, India Coimbatore TAMIL NADU
09894257706 0422-4366618 drsrikanthcbe@gmail.com
Dr Pravin Supe Dinkar
Supe Heart & Diabetes Hospital & Research Centre
Supe Heart & Diabetes Hospital & Research Centre, Department of Clinical Research,Opp. Adhar Ashram, Near Rungtha School, Gharpure Ghat, Ashok Stambh, Nasik - 422002, Maharashtra, India Nashik MAHARASHTRA
09405366165 02532232483 pravinsupe@ymail.com
Dr Raghvendra Belgaonkar
Sushruta Multispeciality Hospital & Research Centre
Sushruta Multispeciality Hospital & Research Centre Private. Limited,Department of General Medicine & Cardiology,
P.B Road, Vidyanagar, Hubli - 580021 Dharwad KARNATAKA
13vPnC contains saccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria toxin cross-reactive material 197 (CRM197). The vaccine is formulated to contain 2.2g of each saccharide, except for 4.4g of 6B, per 0.5-mL dose. The vaccine contains 5 mM succinate buffer, 0.85% sodium chloride, 0.02% polysorbate 80, and 0.125 mg aluminum as aluminum phosphate, per 0.5-mL dose. 13vPnC will be provided as a 0.5-mL dose in a prefilled syringe. All subjects will receive a single dose (0.5 mL) of 13vPnC intramuscularly into the deltoid muscle.
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
6.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject or the subject’s parent/legal guardian has been informed of all pertinentaspects of the study. If a subject or the subject’s parent/legal guardian is illiterate, he/she must make his/her mark (eg, thumbprint) on the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process. If consent is provided by a subject’s parent/legal guardian, the subject’s assent may also be required depending on local requirements.
2. Male or female adults 50 to 65 years of age; or male or female children 6 to 17 years of age at the time of enrollment.
3. Healthy subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of 13vPnC, are eligible.
4. Subjects or the subjects’ parent/legal guardians who are willing and able to comply with scheduled visits and other study procedures.
5. Subjects or subjects’ parent/legal guardians are expected to be available for the duration of the study.
6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is
sexually active.
7. Negative urine pregnancy test for all female subjects who are of childbearing potential.
ExclusionCriteria
Details
1. Subjects or parents/legal guardians who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.
3. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or 13vPnC administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
4. Immunocompromised persons with known or suspected immunodeficiency or who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer, HIV infection, or autoimmune disease.
5. Severe chronic disorder, including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder which, in the investigator’s opinion, precludes the subject from participating in the study.
6. Documented Streptococcus pneumoniae infection within the past 5 years before 13vPnC administration.
7. Receipt of any plasma products or immunoglobulins within 60 days preceding 13vPnC administration or anticipated receipt before study completion.
8. Vaccination with any licensed or investigational pneumococcal vaccine within the last
year.
9. Participation in other studies within 28 days before the current study begins and/or during study participation. Participation in observational studies is permitted.
10. Permanent residence in a nursing home, or other residential care facility. An ambulatory subject who is a resident of a retirement home or village is eligible for the study.
11. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception throughout the study.
Inclusion and exclusion criteria for participant selection, including age and sex. Age and sex to be mentioned in specific boxes.
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence of AEs collected by the investigator after clinical evaluation and in response to nonspecific questions on the subject’s health.Immunogencity objective: Functional antibody titers as measured by serotype-specific OPA assays before and approximately 1 month after 13vPnC administration.
Timepoint:Baseline and 28-42days after vaccination
Secondary Outcome
Outcome
TimePoints
N/A
N/A
Target Sample Size
Total Sample Size="1200" Sample Size from India="1200" 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 4
Date of First Enrollment (India)
16/06/2014
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="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a phase 4, open-label, single-arm, multicenter study to describe the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in adults 50 to 65 years of age and in children 6 to 17 years of age in India.
In the adult cohort 50 to 65 years of age, 1400 subjects will receive a single dose of 13vPnC. In a subset of 400 subjects, 2 blood samples will be collected immediately before and approximately 1 month after vaccination for assessment of the immune responses. Safety will be assessed in all subjects throughout the study.
In the pediatric cohort 6 to 17 years of age, 200 subjects will receive a single dose of 13vPnC, 2 blood samples will be collected immediately before and approximately 1 month after vaccination for assessment of the immune response. Safety will be assessed in all subjects throughout the study.