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

Condition(s) studied

Investigational drug(s) / intervention(s)

PG4: Multivalent Pneumococcal Vaccine

20-valent pneumococcal conjugate vaccine (20vPnC): 20-valent pneumococcal conjugate vaccine (20vPnC)

Study 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.

Eligibility

Primary outcome measure(s)

• Percentage of participants reporting local reactions within 7 days after each dose — Day 7
  Prompted local reactions after each dose
• Percentage of participants reporting systemic events within 7 days after each dose — Day 7
  Prompted systemic events after each dose
• Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 — Dose 1 to 1 month after Dose 3
  AEs occurring from Dose 1 to 1 month after Dose 3
• Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 — Dose 4 to 1 month after Dose 4
  AEs occurring from Dose 4 to 1 month after Dose 4
• Percentage of participants reporting serious adverse events (SAEs) — Dose 1 to 6 months after Dose 4
  SAEs occurring from Dose 1 to 6 months after Dose 4
• Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3 — 1 month after Dose 3
  Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3
• Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4 — 1 month after Dose 4
  Pneumococcal IgG GMCs 1 month after Dose 4

Trial sites (124)

+ 84 more sites — see the full list on the official registry below.

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