Pneumococcal Disease
Conditions
Brief 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.
Interventions
BIOLOGICALPG4
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
42 Days to 211 Days
Healthy volunteers
Yes
Inclusion criteria
* 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.
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, or planned receipt through study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Percentage of participants reporting systemic events within 7 days after each dose | Day 7 | Prompted systemic events after each dose |
| Percentage of participants reporting local reactions within 7 days after each dose | Day 7 | Prompted local reactions after each dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 | 1 month after Dose 4 | Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 |
| Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 | 1 month after Dose 3 | Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 |
| Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 | 1 month after Dose 4 | Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 |
| Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3 | 1 month after Dose 3 | Pneumococcal OPA titers 1 month after Dose 3 |
| Pneumococcal OPA titers prior to Dose 4 | Prior to Dose 4 | Pneumococcal OPA titers prior to Dose 4 |
| Pneumococcal OPA titers 1 month after Dose 4 | 1 month after Dose 4 | Pneumococcal OPA titers 1 month after Dose 4 |
| Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 | 1 month after Dose 4 | Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 |
| Pneumococcal IgG concentrations 1 month after Dose 3 | 1 month after Dose 3 | Pneumococcal IgG concentrations 1 month after Dose 3 |
| Pneumococcal IgG concentrations prior to Dose 4 | Prior to Dose 4 | Pneumococcal IgG concentrations prior to Dose 4 |
| Pneumococcal IgG concentrations 1 month after Dose 4 | 1 month after Dose 4 | Pneumococcal IgG concentrations 1 month after Dose 4 |
| IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4 | Before Dose 4 to 1 month after Dose 4 | IgG GMFR from before Dose 4 to 1 month after Dose 4 |
| IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4 | 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 |
| Percentages of participants with prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 | 1 month after Dose 3 | Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3 |
| Geometric mean of antibody levels to measles, mumps, rubella, varicella, and hepatitis A virus antigens 1 month after Dose 4 | 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 |
| Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3 | 1 month after Dose 3 | Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3 |
| Pneumococcal IgG GMCs 1 month after Dose 3 | 1 month after Dose 3 | Pneumococcal IgG GMCs 1 month after Dose 3 |
| Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3 | 1 month after Dose 3 | Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3 |
Countries
Japan, Puerto Rico, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed