| CTRI Number |
CTRI/2024/04/065558 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan |
|
Scientific Title of Study
|
A Phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent Pneumococcal conjugate vaccine given in a series of 3 infant doses and
1 toddler dose in infants in India and Taiwan. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT05512819 |
ClinicalTrials.gov |
| Protocol B7471024(Final Protocol Amendment 1, 06 Nov 2023) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla
Complex, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director Clinical Site Operations – India Cluster |
| Affiliation |
Pfizer Limited |
| Address |
The Capital, 1802-1901, Plot No. C-70, G Block, Bandra Kurla
Complex, Bandra (East)
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Inc. 66 Hudson Boulevard East New York, NY 10001 |
|
|
Primary Sponsor
|
| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East New York, NY 10001 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Taiwan |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh M |
BGS Global Institute of Medical Sciences and Hospital |
Department of Pediatrics, BGS Global Institute of Medical Sciences and Hospital, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore, Karnataka-560060
Bangalore
KARNATAKA |
9900111261
drrameshm.research@gmail.com |
| Dr Sonali Hemant Palkar |
Bharati Vidyapeeth (Deemed to Be University) Medical College Hospital and Research Centre |
Department of Pediatrics, Pune- Satara Road, Dhankawadi Pune 411043
Pune
MAHARASHTRA |
9881008717
palkarsh@gmail.com |
| Dr Sharad Agarkhedkar |
Dr.D.Y.Patil Medical College,Hospital &Research Centre |
Department of Pediatrics, Dr.D.Y.Patil Medical College,Hospital &Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9822030122
agarkhedkar@gmail.com |
| Dr Monjori Mitra |
Institute of Child Health |
11 Dr. Biresh Guha Street,
Kolkata 700017
Kolkata
WEST BENGAL |
9831075734
monjorimr@gmail.com |
| Dr Jai Prakash Narayan |
Jawahar Lal Nehru Medical College |
Kala Bagh, Ajmer – 305001 Rajasthan
Ajmer
RAJASTHAN |
93142-94402
Narayan_jaiprakash@yahoo.com |
| Dr Anurag Agarwal |
Maulana Azad Medical College and Associated with Lok Nayak Hospital |
Department of Pediatrics, Bahadur Shah Zafar Marg, New Delhi 110002
New Delhi
DELHI |
9810409625
doctoranuragagarwal@gmail.com |
| Dr Nirmalkumar Ganeshmal Choraria |
Nirmal Hospital Pvt Ltd |
Ring Road, Surat 395002
Surat
GUJARAT |
9825142549
drnirmalchoraria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D.Y. Patil Vidyapeeth |
Submittted/Under Review |
| IEC, Jawahar Lal Nehru Medical College |
Submittted/Under Review |
| Institutional Ethics Committee ICH, Institute of Child Health |
Submittted/Under Review |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to Be University) |
Submittted/Under Review |
| Institutional Ethics Committee, Department of Community Medicine |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College |
Submittted/Under Review |
| Nirmal Hospital Pvt Ltd Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pneumococcal Disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
13-valent pneumococcal conjugate vaccine |
Participants will receive 20vPnC or 13vPnC vaccine with site-based randomization. Infant doses will be given at approx 6, 10, 14 weeks of age and toddler doses at approx 12-15 months of age. |
| Intervention |
20-valent pneumococcal conjugate vaccine |
Participants will receive 20vPnC or 13vPnC vaccine with site-based randomization. Infant doses will be given at
approx 6, 10, 14 weeks of age and toddler doses at approx 12-15 months of age |
|
|
Inclusion Criteria
|
| Age From |
42.00 Day(s) |
| Age To |
84.00 Day(s) |
| Gender |
Both |
| Details |
1. Male or female infants born at ≥36 weeks of gestation and approximately 42 to 84 days of age at the time of consent
2. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
3. Weight of 3.0 kg or greater at the time of randomization
|
|
| ExclusionCriteria |
| Details |
1. History of severe adverse reaction associated with a vaccine and or severe allergic reaction eg. anaphylaxis to any component of 13vPnC, 20vPnC or any other diphtheria toxoid containing vaccine
2. Major known congenital malformation or serious chronic disorder
3. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study
4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportions of participants with local reactions (redness, swelling, and pain at the injection site).
2. Proportions of participants with systemic events (fever, decreased appetite drowsiness or increased sleep, and irritability).
3. Proportions of participants with AEs from Dose 1 through 1 month after Dose 3 in each group
4. Proportions of participants with AEs from Dose 4 through 1 month after Dose 4 in each group
5. Proportions of participants with AEs from Dose 4 through 1 month after Dose 4 in each group
6. Pneumococcal IgG at approximately 1 month after Dose 4 in each group (India participants only)
|
1. Day 7
2. Day 7
3. Dose 1 to 1 month after Dose 3
4. Dose 4 to 1 month after Dose 4
5. Dose 1 to 1 month after Dose 4
6. 1 month after Dose 4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Geometric mean concentrations (GMCs) of pneumococcal IgG at approximately 1 month after Dose 3 in each vaccine group |
1 month after Dose 3 |
| Percentages of participants with predefined serotype specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group |
1 month after Dose 3 |
Pneumococcal IgG at approximately 1 month after Dose 4 in each vaccine group
(Taiwan participants only) |
1 month after Dose 4 |
| Percentages of participants with predefined serotype specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group |
1 month after Dose 4 |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="350"
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 3 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers. This study is enrolling participants who are: 1. Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study 2. Have a bodyweight of at least 3 kg Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4 dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28 to 70 days after Dose 1, and Dose 3 will be given 28 to 70 days after Dose 2. Dose 4 will be given at 365 to 455 days (approximately 12 to 15 months) of age. Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant’s health and take some blood samples during the visit. |