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

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05512819
• Collaborator: (none)
• Enrollment: 450
• Arms: 2
• Anticipated Duration (Months): 19.9

Study Details

Study Description

Brief Summary

This study is designed to assess safety and immunogenicity of 4 doses of 20vPnC in healthy infants and toddlers India and Taiwan

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Disease	Biological: 20-valent pneumococcal conjugate vaccine; Biological: 13-valent pneumococcal conjugate vaccine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Anticipated Study Start Date: Aug 31, 2022
• Anticipated Primary Completion Date: Apr 29, 2024
• Anticipated Study Completion Date: Apr 29, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (20vPnC)	Biological: 20-valent pneumococcal conjugate vaccine; 20-valent pneumococcal conjugate vaccine
Active Comparator: 13-valent pneumococcal conjugate vaccine Pneumococcal conjugate vaccine (13vPnC)	Biological: 13-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine

Outcome Measures

Primary Outcome Measures

1. Percentage of participants with local reactions (redness, swelling, and pain at the injection site) [Day 7]

   Prompted local reactions after each dose

2. Percentage of participants with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) [Day 7]

   Prompted systemic reactions after each dose

3. Percentage of participants with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group [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 with AEs from Dose 4 through 1 month after Dose 4 in each group [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 with SAEs from Dose 1 through 1 month after Dose 4 in each group [Dose 1 to 1 month after Dose 4]

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

Secondary Outcome Measures

1. Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group [1 month after Dose 3]

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

2. 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]

   IgG concentrations for 20vPnC serotypes 1 month after Dose 3

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

   IgG GMCs for the 20vPnC serotypes 1 month after Dose 4

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]

   IgG concentrations for 20vPnC serotypes 1 month after Dose 4

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Days to 84 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05512819
• Other Study ID Numbers: B7471024
• First Posted: Aug 23, 2022
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumococcal Infections; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Aug 23, 2022