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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2025-000542-25-Outside-EU/EEA
Enrollment
Unknown
Registered
2026-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Disease

Interventions

Trade Name: Prevenar 20 Product Name: 20-valent Pneumococcal Conjugate Vaccine (20vPnC) Product Code: PF-06482077 Pharmaceutical Form: Suspension for injection Trade Name: Prevenar 13 Product Name: 1

Sponsors

Pfizer Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female infants born at >=36 weeks of gestation - Age at entry: 42 to 84 days of age (India) or 56 to 84 days of age (Taiwan) at the time of consent - Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. Are the trial subjects under 18? yes Number of subjects for this age range: 540 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) - Significant neurological disorder or history of seizure including febrile seizure - Major known congenital malformation or serious chronic disorder - Known or suspected immunodeficiency, or congenital, functional, or surgical asplenia - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results

Design outcomes

Primary

MeasureTime frame
Main Objective: To describe the safety and immunogenicity profile of 20vPnC;Secondary Objective: To further describe the immune responses to 20vPnC;Primary end point(s): - Percentage of participants reporting prompted local reactions within 7 days after each dose in each group - Percentage of participants reporting prompted systemic events within 7 days after each dose in each group - Percentage of participants reporting Adverse Events (AEs) from Dose 1 through 1 month after Dose 3 in each group - Percentage of participants reporting Adverse Events (AEs) from Dose 4 through 1 month after Dose 4 in each group - Percentage of participants reporting Serious Adverse Events (SAEs) from Dose 1 through 1 month after Dose 4 in each group - (India Participants only) IgG GMCs for the 20vPnC serotypes at 1 month after Dose 4 in each group;Timepoint(s) of evaluation of this end point: - Day 7 - Day 7 - Dose 1 through 1 month after Dose 3 - Dose 4 through 1 month after Dose 4 - Dose 1 through 1 month after Dose 4 - 1 month after Dose 4—

Secondary

MeasureTime frame
Secondary end point(s): - IgG GMCs for the 20vPnC serotypes at 1 month after Dose 3 in each group - Percentages of participants with predefined serotype-specific IgG concentration for the 20vPnC serotypes at 1 month after Dose 3 in each group;Timepoint(s) of evaluation of this end point: - 1 month after dose 3 - 1 month after dose 3—

Countries

India, Taiwan

Contacts

Public ContactClinicalTrials.gov Call Center

Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026