Actively Recruiting
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Led by Pfizer · Updated on 2026-06-05
3230
Participants Needed
73
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of a new pneumococcal vaccine compared to the current 20-valent pneumococcal conjugate vaccine (20vPnC) in healthy infants. This Phase 3 randomized, double-blind trial aims to understand how the new vaccine helps protect against infections like pneumonia, meningitis, and ear infections caused by Streptococcus pneumoniae. The study will measure the body's protein production to fight these germs and assess if the new vaccine can provide additional protection against strains not covered by existing vaccines. The study divides participants into three groups based on age and location. Group 1 includes about 3000 infants aged 2 months, who will receive either the new vaccine (PG4) or 20vPnC by injection into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Groups 2 and 3, consisting of about 140 and 90 infants respectively from outside the United States aged 2 to 6 months, will receive similar vaccine schedules with some variations in administration routes and timing. Group 3 may receive the new vaccine either intramuscularly or under the skin. The vaccine doses and schedules vary slightly among groups to compare safety and immune responses. Participants will be involved for about 12 to 19 months depending on their group. During this time, there will be six clinic visits and one phone call to monitor for side effects and collect data. Parents or guardians will report any reactions, and infants will have three blood samples taken to measure immune response. Researchers will track local reactions, systemic events, adverse events, and serious adverse events. The study will review antibody levels and immune activity after doses to assess how well the vaccines work and their safety over time.
CONDITIONS
Brief Title
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants who are 2 months old in Group 1
- Infants who are 2 to 6 months old in Groups 2 and 3
- Healthy infants as determined by medical history and clinical assessment
You will not qualify if you...
- History of severe adverse reaction or severe allergic reaction to a vaccine (e.g., anaphylaxis)
- Major congenital malformation or serious chronic disorder
- Any acute or chronic medical or psychiatric condition or lab abnormality that increases risk or interferes with study participation or results
- Previous or planned pneumococcal vaccination outside this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Dose 1 through 1 month after Dose 4
Participants receive multiple doses of a pneumococcal vaccine to evaluate safety, tolerability, and immune response.
4 vaccination visits and follow-up visits 1 month after Dose 3 and Dose 4
Duration - Up to 6 months after Dose 4
Participants are monitored for safety and immune response up to 6 months after the final dose.
Periodic visits for safety monitoring
Trial Site Locations
Total: 73 locations
1
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States, 72703
Not Yet Recruiting
3
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States, 72401
Not Yet Recruiting
4
San Gabriel Woman's Health
Arcadia, California, United States, 91007
Not Yet Recruiting
5
Family Medical Clinic
El Monte, California, United States, 91731
Not Yet Recruiting
6
Clinical Research of Central California
Fresno, California, United States, 93704
Actively Recruiting
7
SeraCollection Research Services, LLC
Montebello, California, United States, 90640
Not Yet Recruiting
8
Stanford University Medical Center CTRU - 800 Welch Road
Palo Alto, California, United States, 94304
Not Yet Recruiting
9
C & R Research Services USA
Homestead, Florida, United States, 33030
Actively Recruiting
10
Florida Pharmaceutical Research and Associates, Inc.
Miami, Florida, United States, 33143
Actively Recruiting
11
Bioresearch Partner
Miami, Florida, United States, 33155
Not Yet Recruiting
12
Gold Coast Health Research Center, LLC
Miami, Florida, United States, 33155
Not Yet Recruiting
13
Dade Research Center
Miami, Florida, United States, 33173
Not Yet Recruiting
14
Vasconcello-Cohen MD Research, LLC.
Miami, Florida, United States, 33183
Not Yet Recruiting
15
Riveldi and Associates
Miami Lakes, Florida, United States, 33014
Not Yet Recruiting
16
Eminent Clinical Research and Associates
North Lauderdale, Florida, United States, 33068
Actively Recruiting
17
Cordova Research Institute LLC
Sweetwater, Florida, United States, 33182
Not Yet Recruiting
18
Altruistic Clinical Research Global
Norcross, Georgia, United States, 30093
Actively Recruiting
19
Medical Research Partners
Ammon, Idaho, United States, 83406
Not Yet Recruiting
20
ASR, LLC
Boise, Idaho, United States, 83702
Not Yet Recruiting
21
MidValley Research, Inc
Moline, Illinois, United States, 61265
Not Yet Recruiting
22
The Iowa Clinic.
Ankeny, Iowa, United States, 50023
Not Yet Recruiting
23
Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
West Des Moines, Iowa, United States, 50265
Not Yet Recruiting
24
Integrity Clinical Network, LLC
Derby, Kansas, United States, 67037
Not Yet Recruiting
25
ACC Pediatric Research
Haughton, Louisiana, United States, 71037
Actively Recruiting
26
Kur Research, LLC
Columbia, Maryland, United States, 21045
Not Yet Recruiting
27
Michigan Institute of Research
Allen Park, Michigan, United States, 48101
Not Yet Recruiting
28
Michigan Center of Medical Research
Bingham Farms, Michigan, United States, 48025
Not Yet Recruiting
29
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Not Yet Recruiting
30
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68504
Not Yet Recruiting
31
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68505
Not Yet Recruiting
32
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68516
Actively Recruiting
33
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68522
Actively Recruiting
34
University of Rochester Medical Center
Rochester, New York, United States, 14642
Not Yet Recruiting
35
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27703
Actively Recruiting
36
Durham Pediatrics at North Duke Street
Durham, North Carolina, United States, 27704
Actively Recruiting
37
Wilmington Health
Wilmington, North Carolina, United States, 28405
Not Yet Recruiting
38
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States, 45245
Not Yet Recruiting
39
PriMED Clinical Research
Dayton, Ohio, United States, 45429
Not Yet Recruiting
40
Senders Pediatrics
South Euclid, Ohio, United States, 44121
Actively Recruiting
41
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States, 16506
Not Yet Recruiting
42
Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
Simpsonville, South Carolina, United States, 29680
Actively Recruiting
43
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, United States, 37388
Not Yet Recruiting
44
Proactive RGV
Brownsville, Texas, United States, 78520
Not Yet Recruiting
45
Proactive Clinical Research LLC
Edinburg, Texas, United States, 78539
Not Yet Recruiting
46
Proactive El Paso,LLC
El Paso, Texas, United States, 79902
Not Yet Recruiting
47
Neutra Life Sciences
Houston, Texas, United States, 77042
Not Yet Recruiting
48
Mercury Clinical Research (Administrative Office)
Houston, Texas, United States, 77054
Actively Recruiting
49
Kool Kids Pediatrics
Houston, Texas, United States, 77065
Not Yet Recruiting
50
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, United States, 77077
Actively Recruiting
51
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States, 77087
Actively Recruiting
52
Houston Clinical Research Associates
Houston, Texas, United States, 77090
Not Yet Recruiting
53
SMS Clinical Research LLC
Mesquite, Texas, United States, 75149
Actively Recruiting
54
Pediatric Center- Neutra Life Sciences
Richmond, Texas, United States, 77469
Not Yet Recruiting
55
AMR Clinical
Provo, Utah, United States, 84604
Not Yet Recruiting
56
AMR Clinical
Syracuse, Utah, United States, 84075
Not Yet Recruiting
57
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Actively Recruiting
58
Tekton Research, LLC.
Richmond, Virginia, United States, 23233
Not Yet Recruiting
59
Shindo children's clinic
Fukuoka, Fukuoka, Japan, 814-0121
Not Yet Recruiting
60
Yokoyama Children'S Clinic
Kasuga, Fukuoka, Japan, 816-0801
Not Yet Recruiting
61
Ohigesenseino Kodomo Clinic
Sapporo, Hokkaido, Japan, 062-0907
Not Yet Recruiting
62
Futaba Clinic
Shinjuku-ku, Tokyo, Japan, 160-0017
Not Yet Recruiting
63
Kose Children Clinic
Kofu, Yamanashi, Japan, 400-0853
Not Yet Recruiting
64
Fukui Aiiku Hospital
Fukui, Japan, 910-0833
Not Yet Recruiting
65
Kubota Children's Clinic
Osaka, Japan, 544-0033
Not Yet Recruiting
66
Clinical Research Investigator Group
Bayamón, Puerto Rico, 00960
Not Yet Recruiting
67
Caguas Clinical Research
Caguas, Puerto Rico, 00725
Not Yet Recruiting
68
San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, Puerto Rico, 00726
Not Yet Recruiting
69
Clinical Research Puerto Rico
Guayama, Puerto Rico, 00784
Not Yet Recruiting
70
Ponce Medical School Foundation Inc./ CAIMED Center
Ponce, Puerto Rico, 00716
Not Yet Recruiting
71
BRCR Global Puerto Rico
Ponce, Puerto Rico, 00717
Not Yet Recruiting
72
BRCR Global Puerto Rico
San Juan, Puerto Rico, 00907
Not Yet Recruiting
73
San Miguel Medical
Trujillo Alto, Puerto Rico, 00976-3910
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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