A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

NCT07629440
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
3,230
clinicaltrials.gov
Lead sponsor
Pfizer
clinicaltrials.gov
Start date
2026-05-29
clinicaltrials.gov
Number of sites
97
clinicaltrials.gov

Summary
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Infants will have 3 blood samples collected.
clinicaltrials.gov
Short title
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
clinicaltrials.gov
Official title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
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Completion date
2029-06-05
clinicaltrials.gov
First posted
2026-06-05
clinicaltrials.gov
Registry last updated
2026-07-09
clinicaltrials.gov
Primary completion date
2029-06-05
clinicaltrials.gov
Start date
2026-05-29
clinicaltrials.gov

Participants
3,230
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
3,230
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
97
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
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Lead sponsor
Pfizer
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07629440
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07629440
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting local reactions within 7 days after each dose

    Timeframe: Day 7

    Prompted local reactions after each dose

  2. Percentage of participants reporting systemic events within 7 days after each dose

    Timeframe: Day 7

    Prompted systemic events after each dose

  3. Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3

    Timeframe: Dose 1 to 1 month after Dose 3

    AEs occurring from Dose 1 to 1 month after Dose 3

  4. Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4

    Timeframe: Dose 4 to 1 month after Dose 4

    AEs occurring from Dose 4 to 1 month after Dose 4

  5. Percentage of participants reporting serious adverse events (SAEs)

    Timeframe: Dose 1 to 6 months after Dose 4

    SAEs occurring from Dose 1 to 6 months after Dose 4

  6. Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3

  7. Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Pneumococcal IgG GMCs 1 month after Dose 4

  1. Pneumococcal IgG GMCs 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Pneumococcal IgG GMCs 1 month after Dose 3

  2. Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3

  3. Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4

  4. Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3

  5. Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4

  6. Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Pneumococcal OPA titers 1 month after Dose 3

  7. Pneumococcal OPA titers prior to Dose 4

    Timeframe: Prior to Dose 4

    Pneumococcal OPA titers prior to Dose 4

  8. Pneumococcal OPA titers 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Pneumococcal OPA titers 1 month after Dose 4

  9. Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4

  10. Pneumococcal IgG concentrations 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Pneumococcal IgG concentrations 1 month after Dose 3

  11. Pneumococcal IgG concentrations prior to Dose 4

    Timeframe: Prior to Dose 4

    Pneumococcal IgG concentrations prior to Dose 4

  12. Pneumococcal IgG concentrations 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Pneumococcal IgG concentrations 1 month after Dose 4

  13. IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4

    Timeframe: Before Dose 4 to 1 month after Dose 4

    IgG GMFR from before Dose 4 to 1 month after Dose 4

  14. IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4

    Timeframe: From 1 month after Dose 3 to 1 month after Dose 4

    IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4

  15. Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3

  16. Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4

    Timeframe: 1 month after Dose 4

    Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4

  17. Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3

    Timeframe: 1 month after Dose 3

    Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children
Minimum age
42 Days
Maximum age
211 Days
Healthy volunteers
Yes

  • infants who are 2 months of age in Group 1.
  • infants who are 2 to 6 months of age in Groups 2 and 3.
  • Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
  • 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 investigational product 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.
Sources for eligibility
clinicaltrials.gov

  • Alabama Clinical Therapeutics, LLC Birmingham Pediatric AssociatesBirmingham, United StatesRecruiting
  • University of Alabama at Birmingham - School of MedicineBirmingham, United StatesNot yet recruiting
  • KUR Research, LLCCentreville, United StatesNot yet recruiting
  • Northwest Arkansas Pediatric ClinicFayetteville, United StatesRecruiting
  • The Children's Clinic of Jonesboro, P.A.Jonesboro, United StatesRecruiting
  • Helios Clinical ResearchSherwood, United StatesNot yet recruiting
  • San Gabriel Woman's HealthArcadia, United StatesRecruiting
  • Family Medical ClinicEl Monte, United StatesRecruiting
  • Clinical Research of Central CaliforniaFresno, United StatesRecruiting
  • SeraCollection Research Services, LLCMontebello, United StatesRecruiting
  • Bailony PediatricsNational City, United StatesNot yet recruiting
  • Stanford University Medical CenterPalo Alto, United StatesNot yet recruiting
  • Childrens Hospital of ColoradoAurora, United StatesRecruiting
  • Direct Helpers Research CenterHialeah, United StatesRecruiting
  • C & R Research Services USAHomestead, United StatesRecruiting
  • Florida Pharmaceutical Research and Associates, Inc.Miami, United StatesRecruiting
  • Bioresearch PartnerMiami, United StatesRecruiting
  • Gold Coast Health Research Center, LLCMiami, United StatesRecruiting
  • Dade Research CenterMiami, United StatesNot yet recruiting
  • Vasconcello-Cohen MD Research, LLC.Miami, United StatesNot yet recruiting
  • Riveldi and AssociatesMiami Lakes, United StatesRecruiting
  • Eminent Clinical Research and AssociatesNorth Lauderdale, United StatesRecruiting
  • Cordova Research Institute LLCSweetwater, United StatesRecruiting
  • Altruistic Clinical Research GlobalNorcross, United StatesRecruiting
  • Medical Research PartnersAmmon, United StatesRecruiting

And 72 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)