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NCT05512819 Clinical Trial

A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05512819
Other study ID # B7471024
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 16, 2022
Est. completion date January 22, 2026

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 190
Est. completion date January 22, 2026
Est. primary completion date February 20, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 42 Days to 84 Days
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
• 13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine

Locations
Country Name City State
India BGS Global Institute of Medical Sciences (BGSGIMS) Bangalore Karnataka
India Nirmal Hospital Pvt Ltd. Surat Gujarat
Taiwan Hsinchu Mackay Memorial Hospital Hsinchu City Hsinchu
Taiwan Taichung Veterans General Hospital Taichung
Taiwan Mackay Memorial Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

India,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country Prompted local reactions after each dose Day 7
Primary Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country Prompted systemic reactions after each dose Day 7
Primary 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 Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group Dose 1 to 1 month after Dose 3
Primary Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group Dose 4 to 1 month after Dose 4
Primary Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country SAEs occurring up to 1 month after Dose 4 in each group Dose 1 to 1 month after Dose 4
Primary GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only 1 month after Dose 4
Secondary Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country IgG GMCs for the 20vPnC serotypes 1 month after Dose 3 1 month after Dose 3
Secondary 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 IgG concentrations for 20vPnC serotypes 1 month after Dose 3 1 month after Dose 3
Secondary GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only 1 month after Dose 4
Secondary 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 IgG concentrations for 20vPnC serotypes 1 month after Dose 4 1 month after Dose 4
See also
  Status Clinical Trial Phase
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Recruiting NCT06044077 - A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Phase 3
Completed NCT02146365 - Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
Completed NCT04525599 - A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator Phase 1
Completed NCT04530838 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants Phase 3
Active, not recruiting NCT06026748 - A Phase I Study of XJ103 in Chinese Healthy Subjects Phase 1
Completed NCT04526574 - Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age Phase 3
Completed NCT05329259 - A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India Phase 4
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Completed NCT01298544 - A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers Phase 4
Completed NCT04830358 - Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults Phase 1
Completed NCT04379713 - 20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants Phase 3
Completed NCT04887948 - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Phase 3
Completed NCT04382326 - 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants Phase 3
Not yet recruiting NCT00843895 - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years N/A
Completed NCT01734239 - A Phase III Clinical Trial to Study the Safety and Immunogenicity of Pneumovax™ 23 (V110) in Participants From the Russian Population (V110-018) Phase 3
Completed NCT05408429 - Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13 Phase 3

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