CTRI/2021/04/032693 [Registered on: 09/04/2021] Trial Registered Prospectively
Last Modified On:
15/07/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to know about effects of 15-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccinations.
Scientific Title of Study
A Phase 3, Observer blind, Randomized, Active-Controlled Trial Evaluating the Immunologic Non-inferiority, Safety and Tolerability of a 15-valent Pneumococcal Conjugate Vaccine Compared to a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given with Routine Pediatric Vaccinations.
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
CBCC/2020/029, Version No. 1.0 dated 09/Nov/2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sandeep Singh
Designation
Vice President - Clinical Operations
Affiliation
CBCC Global Research LLP
Address
Second Floor, Skoda House, Opposite L J Campus S G Highway, Sarkhej, Ahmedabad, GUJARAT – 382210,
India
Ahmadabad GUJARAT 382210 India
Phone
9637555304
Fax
9726434204
Email
sandeep.singh@cbccusa.com
Details of Contact Person Scientific Query
Name
Dr Arani Chatterjee
Designation
Senior Vice President – Clinical Research
Affiliation
Aurobindo Pharma Ltd.
Address
APL Reseaerch Centre II, Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana – 502329, India
Medak TELANGANA 502329 India
Phone
7730063444
Fax
Email
arani.chatterjee@aurobindo.com
Details of Contact Person Public Query
Name
Mr K Sathyan
Designation
Whole Time Director
Affiliation
Tergene Biotech Pvt. Ltd.
Address
Suite 121 & 122, Building 450, Genome Valley, Turkapally Village, Shamirpet Mandal, Rangareddy District, Hyderabad, Telangana – 500078, India
Hyderabad TELANGANA 500078 India
Phone
9987648486
Fax
Email
ks@tergene.com
Source of Monetary or Material Support
Biotechnology Industry Research Assistance Council (BIRAC), 1st Floor, MTNL Building, 9 CGO Complex Lodhi Road, New Delhi-110003, India
Tergene Biotech Pvt. Ltd.
(A Subsidiary of Aurobindo Pharma Ltd)
Suite 121 & 122, Building 450
Genome Valley, Turkapally (V), Shamirpet (M) RR Dist,
Hyderabad 500078, India
Primary Sponsor
Name
Tergene Biotech Pvt Ltd
Address
(A Subsidiary of Aurobindo Pharma Ltd)
Suite 121 & 122, Building 450
Genome Valley, Turkapally (V), Shamirpet (M) RR Dist,
Hyderabad 500078, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NA
NA
Countries of Recruitment
India
Sites of Study
No of Sites = 25
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sachin Damke
Acharya Vinoba Bhave Rural Hospital
Sawangi (Meghe), Wardha - 442004, Maharashtra, India. Wardha MAHARASHTRA
9323234457
buntydamke@gmail.com
Dr Atul Jindal
All India Institute of Medical Sciences (AIIMS)
Great Eastern Road, Tatibandh, Raipur - 492099, Chhattisgarh, India. Raipur CHHATTISGARH
1. Voluntarily obtained informed consent from Parent/ legal guardian/LAR of the infant.
2. Infant aged 6-10 weeks (42-69 days) at enrollment.
3. Healthy infant as determined by medical history, physical exam, and judgment of the investigator.
4. Parent/ legal guardian/ LAR must be able to complete all relevant study procedures during study participation.
ExclusionCriteria
Details
1. Subject with administration history of pneumococcal vaccine
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis or rotavirus vaccines
3. Known hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, rotavirus or pneumococcal vaccines
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
6. Known or suspected immune deficiency or suppression
7. Receipt of blood or gamma-globulin products (including hepatitis B immunoglobulin and monoclonal antibodies)
8. History of cytotoxic therapy, inhaled corticosteroids (not including allergic rhinitis corticosteroid spray treatment, acute uncomplicated dermatitis surfaces corticosteroid therapy)
9. History of culture-proven invasive disease caused by S. pneumoniae or H. influenzae type b (Hib)
10. Any congenital malformation, developmental disorder, genetic defects or severe malnutrition
11. 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.
12. Participation in another investigational trial. Participation in purely observational studies is acceptable.
13. Any co-existing condition which in the opinion of investigator may interfere with the study participation
14. Direct descendant (i.e. child, grandchild) of study site personnel
15. Infants with known Coronavirus infection (COVID-19)
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Percentage of subjects achieving WHO-predefined serotype-specific antibody threshold (Greater than or equal to 0.35 microgram per ml) at End of study (EOS).
The serotype-specific IgG GMC ratios of serotypes common
Proportions that achieve Greater than or equal to 0.35 microgram per ml against each serotype (contained only in the new vaccine;
IgG GMC ratios for serotypes found only in the new vaccine
28 days after completion of 3rd Dose
Secondary Outcome
Outcome
TimePoints
For the serotypes common to the new vaccine and the licensed comparator
Serotype-specific Reverse Cumulative Distribution (RCD) plots for IgG.
For serotypes found only in the new vaccine
RCD plots for serotypes found only in the new vaccine.
Safety Endpoints:
Percentage of subjects reporting Pre-specified local reactions
Percentage of subjects reporting Pre-specified systemic events
28 days after completion of 3rd Dose
7 consecutive days (Day 0-6) post vaccination
Target Sample Size
Total Sample Size="1130" Sample Size from India="1130" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a phase 3, observer blind, randomized, active-controlled trial evaluating
the immunologic non-inferiority, safety and tolerability of a 15-valent
pneumococcal conjugate vaccine compared to a 13-valent pneumococcal conjugate
vaccine in healthy infants given with routine pediatric vaccinations.