A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
Purpose
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.
Condition
- Pneumococcal Disease
Eligibility
- Eligible Ages
- Between 42 Days and 211 Days
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Parallel assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1 PG4 (intramuscular) |
Multivalent Pneumococcal Vaccine |
|
|
Active Comparator Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) |
20-valent pneumococcal conjugate vaccine (20vPnC) |
|
|
Experimental Group 2 PG4 (intramuscular) |
Multivalent Pneumococcal Vaccine |
|
|
Active Comparator Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) |
20-valent pneumococcal conjugate vaccine (20vPnC) |
|
|
Experimental Group 3 PG4 (intramuscular) |
Multivalent Pneumococcal Vaccine |
|
|
Experimental Group 3 PG4 (subcutaneous) |
Multivalent Pneumococcal Vaccine |
|
|
Active Comparator Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) |
20-valent pneumococcal conjugate vaccine (20vPnC) |
|
Recruiting Locations
Birmingham, Alabama 35205
Birmingham, Alabama 35233
Fayetteville, Arkansas 72703
Jonesboro, Arkansas 72401
Sherwood, Arkansas 72120
Anaheim, California 92805
Arcadia, California 91007
Bellflower, California 90706
El Monte, California 91731
Fresno, California 93704
Montebello, California 90640
National City, California 91950
Aurora, Colorado 80045
Hialeah, Florida 33012
Homestead, Florida 33030
Miami, Florida 33143
Miami, Florida 33155
Miami, Florida 33155
Miami, Florida 33173
Miami, Florida 33183
Miami Lakes, Florida 33014
North Lauderdale, Florida 33068
Sweetwater, Florida 33182
Tampa, Florida 33617
Norcross, Georgia 30093
Ammon, Idaho 83406
Blackfoot, Idaho 83221
Boise, Idaho 83702
Idaho Falls, Idaho 83404
Moline, Illinois 61265
Ankeny, Iowa 50023
West Des Moines, Iowa 50265
Derby, Kansas 67037
Haughton, Louisiana 71037
Columbia, Maryland 21045
Allen Park, Michigan 48101
Bingham Farms, Michigan 48025
Dearborn Heights, Michigan 48127
Columbia, Missouri 65201
Columbia, Missouri 65212
Grand Island, Nebraska 68803
Lincoln, Nebraska 68504
Lincoln, Nebraska 68505
Lincoln, Nebraska 68516
Lincoln, Nebraska 68522
East Syracuse, New York 13057
Rochester, New York 14642
Charlotte, North Carolina 28203
Charlotte, North Carolina 28207
Charlotte, North Carolina 28207
Durham, North Carolina 27703
Durham, North Carolina 27704
Matthews, North Carolina 28105
Matthews, North Carolina 28105
Wilmington, North Carolina 28405
Cincinnati, Ohio 45245
Dayton, Ohio 45429
South Euclid, Ohio 44121
Bellevue, Pennsylvania 15202
Cranberry Township, Pennsylvania 16066
Erie, Pennsylvania 16506
Jefferson Hills, Pennsylvania 15025
N. Huntingdon, Pennsylvania 15642
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15217
Pittsburgh, Pennsylvania 15227
Pittsburgh, Pennsylvania 15234
Simpsonville, South Carolina 29680
Summerville, South Carolina 29486
Summerville, South Carolina 29486
Tullahoma, Tennessee 37388
Brownsville, Texas 78520
Edinburg, Texas 78539
El Paso, Texas 79902
Forney, Texas 75126
Galveston, Texas 77555
Houston, Texas 77042
Houston, Texas 77054
Houston, Texas 77065
Houston, Texas 77074
Houston, Texas 77074
Houston, Texas 77077
Houston, Texas 77087
Houston, Texas 77090
Lewisville, Texas 75067
Mansfield, Texas 76063
McAllen, Texas 78504
Mesquite, Texas 75149
Mesquite, Texas 75150
Richmond, Texas 77469
San Antonio, Texas 78215
Provo, Utah 84604
Syracuse, Utah 84075
Richmond, Virginia 23226
Richmond, Virginia 23233
Marshfield, Wisconsin 54449
Bayamón, Puerto Rico 00960
Caguas, Puerto Rico 00725
Caguas, Puerto Rico 00726
Guayama, Puerto Rico 00784
Ponce, Puerto Rico 00716
Ponce, Puerto Rico 00728
San Juan, Puerto Rico 00907
Trujillo Alto, Puerto Rico 00976-3910
More Details
- Status
- Recruiting
- Sponsor
- Pfizer