| CTRI Number |
CTRI/2017/08/009492 [Registered on: 25/08/2017] Trial Registered Prospectively |
| Last Modified On: |
06/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A clinical trial to describe the safety and immunogenicity of 13 valent pneumococcal conjugate vaccine formulated in multidose vials when given with routine pediatric vaccines in healthy infants in India.
Title intended for the lay public in easily understood language. |
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Scientific Title of Study
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A Phase 4 Randomized OpenLabel Trial to Describe the Safety Tolerability and Immunogenicity of 13 Valent Pneumococcal Conjugate Vaccine Formulated in Multidose Vials When Given With Routine Pediatric Vaccines in Healthy Infants in India. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Protocol No: B4671004 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Seema Pai |
| Designation |
Director-India Cluster |
| Affiliation |
Pfizer India |
| Address |
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
08826422322 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director-India Cluster |
| Affiliation |
Pfizer India |
| Address |
Pfizer Limited, The Capital, 1802-1901, Plot No. C 70, G Block, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India |
| Phone |
08826422322 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
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Source of Monetary or Material Support
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| Pfizer Inc
235 East, 42nd Street,
New York, NY 10017, USA |
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Primary Sponsor
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| Name |
Pfizer Limited Subsidiary of Pfizer Inc |
| Address |
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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
Sites of Study
Modification(s)
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bela Hasmukh Shah |
B.J Medical college and Civil Hospital |
Department of Pediatrics, D-4 Block, 1st Floor,
Main Building,
B.J Medical college and Civil Hospital, Asarwa, Ahmedabad-380016,
Gujarat, India
Ahmadabad
GUJARAT |
09879208977
bela_dr@yahoo.co.in |
| Dr Sanjay Kewalchand Lalwani |
Bharati Vidyapeeth University Medical College |
Bharati Hosptial and Research Centre, Department of Pediatrics,
Katraj- Dhankawdi,
Pune-411043,
Maharashtra, India
Pune
MAHARASHTRA |
09822051716
sanjaylalwani2007@rediffmail.com |
| Dr Balasubramanian Sundaram |
Kanchi Kamakoti Childs Trust Hospital |
Kanchi Kamakoti Childs Trust Hospital
12-A, Nageswara Road, Nungambakkam,
Chennai- 600034
Tamil Nadu, India
Chennai
TAMIL NADU |
09840218954
sbsped@gmail.com |
| Dr Amita Sapru |
KEM Hospital Research Centre |
KEM Hospital Research Centre,
Sardar Moodliar Road,
Rasta Peth, Pune- 411011,
Maharashtra, India
Pune
MAHARASHTRA |
09822842094
avsapru@gmail.com |
| Dr N Kartik Nagesh |
Manipal Hospital |
Manipal Hospital, Department of Pediatrics, 98, HAL Airport Road, Bengaluru – 560017
Karnataka, India
Bangalore
KARNATAKA |
09845047960
drkarthiknagesh@gmail.com |
| Dr Dinesh Kaul |
Sir Ganga Ram Hospital |
Department of Pediatrics,
Sir Ganga Ram Hospital,
Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi-110060, India
New Delhi
DELHI |
09811211205
docdineshkaul@gmail.com |
| Dr Padmasani Venkat Ramanan |
Sri Ramachandra Hospital |
Department of Pediatrics
Sri Ramachandra Hospital,
No.1, Ramachandra Nagar, Porur, Chennai - 600116, Tamil Nadu, India
Chennai
TAMIL NADU |
09445140200
srmcinnovis@gmail.com |
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Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals |
Approved |
| Institutional Ethics Committee, B.J Medical college and Civil Hospital |
Approved |
| Institutional Ethics Committee, Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Ethics committee, Sri Ramachandra University |
Approved |
| Institutional Review Board and Ethics Committee of Kanchi Kamakoti Childs Trust Hospital & The Childs Trust Medical Research Foundation |
Approved |
| KEM Hospital Research Centre Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
The prevention of disease caused by S pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F (including sepsis, meningitis, bacteremia, pneumonia, and acute otitis media) |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
13-valent Pneumococcal Conjugate Vaccine with 2-PE in Multidose vials (MDVs) and 13-valent Pneumococcal Conjugate Vaccine without 2-PE in Pre-filled Syringes (PFSs) |
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 CRM. The vaccine is formulated to contain 2.2 microgram of each saccharide, except for 4.4 microgram of 6B, per
0.5-mL dose. The vaccine is formulated with 5 mM succinate buffer, 0.02 percent polysorbate 80,
and 0.125 mg of aluminum as aluminum phosphate, per 0.5-mL dose.
13vPnC MDVs will also contain 4 mg of 2-PE per 0.5-mL dose. Four (4) doses of 13vPnC (2.0 mL) will be contained within each MDV. For the purposes of this study, only a single
0.5-mL dose will be administered from each of the MDVs. |
| Comparator Agent |
Not Applicable |
There is no Comparator Agent |
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Inclusion Criteria
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| Age From |
42.00 Day(s) |
| Age To |
72.00 Day(s) |
| Gender |
Both |
| Details |
1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)or legal guardian(s) has or have been informed of all pertinent aspects of the study.
2. Parent(s) or legal guardian(s) or caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0)
4.Available for the entire study period and whose parent(s) or legal guardian(s) or caregiver(s) can be reached by telephone.
5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
6. Weight of 3.0 kg or greater at the time of vaccination. |
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| ExclusionCriteria |
| Details |
1. Infant who is a direct descendant (child, grandchild) of
• Investigator site staff members directly involved in the conduct of the study, or
• Site staff members otherwise supervised by the investigator, or
• Pfizer employees directly involved in the conduct of the study.
2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and or during study participation. Participation in purely observational studies is acceptable.
3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
7. Major known congenital malformation or serious chronic disorder.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb’s palsy.
9. Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product 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.
10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).
Inclusion and exclusion criteria for participant selection, including age and sex. Age and sex to be mentioned in specific boxes. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
To describe the safety profile of 13vPnC with 2-PE in the MDV group and without 2-PE in the PFS group
Primary Endpoint:
1. Incidence of local reactions and systemic events, Adverse events, serious adverse events and Incidence of newly diagnosed chronic medical conditions at defined time periods in the MDV group and in the PFS group |
From 6 week visit to 1 month after the infant series (13 Month visit) |
|
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Secondary Outcome
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| Outcome |
TimePoints |
To describe the pneumococcal immune responses
induced by 13vPnC with 2-PE in the MDV group and in the PFS group
|
18 week visit and 13 month visit |
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Target Sample Size
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Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "301"
Final Enrollment numbers achieved (India)="301" |
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Phase of Trial
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Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
31/05/2018 |
| Date of Study Completion (India) |
20/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
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Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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None yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a phase 4, randomized, open label trial to describe the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) formulated in multidose vials when given with routine pediatric vaccines in healthy infants in India. This study is being conducted in response to a post approval marketing authorization condition by the Drugs Controller General of India (DCGI) vide letter 27-Jun-2016. Currently 13vPnC is available as a single dose prefilled syringe. Now Pfizer has developed a formulation containing the preservative 2-phenoxyethanol (2-PE) that will allow the vaccine to be supplied in a multi-dose vial presentation with 4 doses per vial. The multi-dose vial presentation with 2-PE will help significantly reduce the cold-chain requirements, storage costs and wastage incurred in delivering the vaccine through large scale public immunization programs. |