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NCT Number: NCT05512819

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

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.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

42 day–84 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nirmal Hospital Pvt Ltd., Surat, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

20-valent pneumococcal conjugate vaccine

Biological

20-valent pneumococcal conjugate vaccine

13-valent Pneumococcal Conjugate Vaccine

Biological

13-valent pneumococcal conjugate vaccine

Primary outcomes

  1. Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country

    Time frame: Day 7

    Prompted local reactions after each dose

  2. Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country

    Time frame: Day 7

    Prompted systemic reactions after each dose

  3. 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

    Time frame: Dose 1 to 1 month after Dose 3

    Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group

  4. Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country

    Time frame: Dose 4 to 1 month after Dose 4

    Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group

  5. Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country

    Time frame: Dose 1 to 1 month after Dose 4

    SAEs occurring up to 1 month after Dose 4 in each group

  6. GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group

    Time frame: 1 month after Dose 4

    IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only

Secondary outcomes

  1. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country

    Time frame: 1 month after Dose 3

    IgG GMCs for the 20vPnC serotypes 1 month after Dose 3

  2. 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

    Time frame: 1 month after Dose 3

    IgG concentrations for 20vPnC serotypes 1 month after Dose 3

  3. GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group

    Time frame: 1 month after Dose 4

    IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only

  4. 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

    Time frame: 1 month after Dose 4

    IgG concentrations for 20vPnC serotypes 1 month after Dose 4

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2022
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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