Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT06531538

CompletedPhase 2

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: PG4, 20-valent pneumococcal conjugate vaccine (20vPnC)

Countries: United States, Puerto Rico

The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.

Eligibility overview

Sex: ALL

Age: 12 Months to 15 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.

Exclusion Criteria:

* 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 (other than 20vPnC) or planned receipt during study participation.
Locations (39)
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Chamblee, Georgia, United States
  • Fayetteville, Georgia, United States
  • Union City, Georgia, United States
  • Ankeny, Iowa, United States
  • Shreveport, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Shreveport, Louisiana, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Columbia, Maryland, United States
  • Charlotte, North Carolina, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Matthews, North Carolina, United States
  • South Euclid, Ohio, United States
  • Charleston, South Carolina, United States
  • Charleston, South Carolina, United States
  • Summerville, South Carolina, United States
  • Summerville, South Carolina, United States
  • Kingsport, Tennessee, United States
  • Tullahoma, Tennessee, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • + 9 more on CT.gov