Clinical trial NCT05512819: A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 401
Sex: ALL
Minimum age (years): 42
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

* Born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study
* 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 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 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.


Eligibility criteria: Inclusion Criteria:

* Male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
* Weight of 3.0 kg or greater at the time of randomization

Exclusion Criteria:

* 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.
* Major known congenital malformation or serious chronic disorder
* 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
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Primary outcomes:
measure: Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country
timeFrame: Day 7
measure: Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
timeFrame: Day 7
measure: Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country
timeFrame: Dose 1 to 1 month after Dose 3
measure: Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country
timeFrame: Dose 4 to 1 month after Dose 4
measure: Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country
timeFrame: Dose 1 to 1 month after Dose 4
measure: GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group
timeFrame: 1 month after Dose 4
Secondary outcomes:
measure: Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country
timeFrame: 1 month after Dose 3
measure: Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country
timeFrame: 1 month after Dose 3
measure: GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group
timeFrame: 1 month after Dose 4
measure: Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country
timeFrame: 1 month after Dose 4
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College and Associated with Lok Nayak Hospital
state: Delhi
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Bangalore
country: India
facility: BGS Global Institute of Medical Sciences (BGSGIMS)
state: Karnataka
city: Pune
country: India
facility: Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
state: Maharashtra
city: Ajmer
country: India
facility: Jawahar Lal Nehru Medical College
state: Rajasthan
city: Kolkata
country: India
facility: Institute of Child Health
state: WEST Bengal
city: Hsinchu City
country: Taiwan
facility: Hsinchu Mackay Memorial Hospital
state: Hsinchu
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: