- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07629440
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Pfizer CT.gov Call Center
- Telefonnummer: 1-800-718-1021
- E-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35205
- Rekruttering
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Arkansas
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Fayetteville, Arkansas, Forenede Stater, 72703
- Ikke rekrutterer endnu
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Forenede Stater, 72401
- Ikke rekrutterer endnu
- The Children's Clinic of Jonesboro, P.A.
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California
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Arcadia, California, Forenede Stater, 91007
- Ikke rekrutterer endnu
- San Gabriel Woman's Health
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El Monte, California, Forenede Stater, 91731
- Ikke rekrutterer endnu
- Family Medical Clinic
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Fresno, California, Forenede Stater, 93704
- Rekruttering
- Clinical Research of Central California
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Montebello, California, Forenede Stater, 90640
- Ikke rekrutterer endnu
- SeraCollection Research Services, LLC
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Palo Alto, California, Forenede Stater, 94304
- Ikke rekrutterer endnu
- Stanford University Medical Center CTRU - 800 Welch Road
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Florida
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Homestead, Florida, Forenede Stater, 33030
- Rekruttering
- C & R Research Services USA
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Miami, Florida, Forenede Stater, 33143
- Rekruttering
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Forenede Stater, 33155
- Ikke rekrutterer endnu
- BioResearch Partner
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Miami, Florida, Forenede Stater, 33155
- Ikke rekrutterer endnu
- Gold Coast Health Research Center, LLC
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Miami, Florida, Forenede Stater, 33173
- Ikke rekrutterer endnu
- Dade Research Center
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Miami, Florida, Forenede Stater, 33183
- Ikke rekrutterer endnu
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Forenede Stater, 33014
- Ikke rekrutterer endnu
- Riveldi and Associates
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North Lauderdale, Florida, Forenede Stater, 33068
- Rekruttering
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Forenede Stater, 33182
- Ikke rekrutterer endnu
- Cordova Research Institute LLC
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Georgia
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Norcross, Georgia, Forenede Stater, 30093
- Rekruttering
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Forenede Stater, 83406
- Ikke rekrutterer endnu
- Medical Research Partners
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Boise, Idaho, Forenede Stater, 83702
- Ikke rekrutterer endnu
- ASR, LLC
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Illinois
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Moline, Illinois, Forenede Stater, 61265
- Ikke rekrutterer endnu
- MidValley Research, Inc
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Iowa
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Ankeny, Iowa, Forenede Stater, 50023
- Ikke rekrutterer endnu
- The Iowa Clinic.
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West Des Moines, Iowa, Forenede Stater, 50265
- Ikke rekrutterer endnu
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
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Kansas
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Derby, Kansas, Forenede Stater, 67037
- Ikke rekrutterer endnu
- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, Forenede Stater, 71037
- Rekruttering
- ACC Pediatric Research
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Maryland
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Columbia, Maryland, Forenede Stater, 21045
- Ikke rekrutterer endnu
- KUR Research, LLC
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Michigan
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Allen Park, Michigan, Forenede Stater, 48101
- Ikke rekrutterer endnu
- Michigan Institute of Research
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Bingham Farms, Michigan, Forenede Stater, 48025
- Ikke rekrutterer endnu
- Michigan Center of Medical Research
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Ikke rekrutterer endnu
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Forenede Stater, 68516
- Rekruttering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forenede Stater, 68522
- Rekruttering
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forenede Stater, 68504
- Ikke rekrutterer endnu
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Forenede Stater, 68505
- Ikke rekrutterer endnu
- Midwest Children's Health Research Institute
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New York
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Rochester, New York, Forenede Stater, 14642
- Ikke rekrutterer endnu
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, Forenede Stater, 27703
- Rekruttering
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Forenede Stater, 27704
- Rekruttering
- Durham Pediatrics at North Duke Street
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Wilmington, North Carolina, Forenede Stater, 28405
- Ikke rekrutterer endnu
- Wilmington Health
-
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45245
- Ikke rekrutterer endnu
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Forenede Stater, 45429
- Ikke rekrutterer endnu
- Primed Clinical Research
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South Euclid, Ohio, Forenede Stater, 44121
- Rekruttering
- Senders Pediatrics
-
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Pennsylvania
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Erie, Pennsylvania, Forenede Stater, 16506
- Ikke rekrutterer endnu
- Allegheny Health and Wellness Pavilion
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South Carolina
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Simpsonville, South Carolina, Forenede Stater, 29680
- Rekruttering
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Tennessee
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Tullahoma, Tennessee, Forenede Stater, 37388
- Ikke rekrutterer endnu
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Brownsville, Texas, Forenede Stater, 78520
- Ikke rekrutterer endnu
- Proactive RGV
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Edinburg, Texas, Forenede Stater, 78539
- Ikke rekrutterer endnu
- Proactive Clinical Research LLC
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El Paso, Texas, Forenede Stater, 79902
- Ikke rekrutterer endnu
- Proactive El Paso,LLC
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Houston, Texas, Forenede Stater, 77065
- Ikke rekrutterer endnu
- Kool Kids Pediatrics
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Houston, Texas, Forenede Stater, 77090
- Ikke rekrutterer endnu
- Houston Clinical Research Associates
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Houston, Texas, Forenede Stater, 77087
- Rekruttering
- Mercury Clinical Research - Pediatric Associates
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Houston, Texas, Forenede Stater, 77042
- Ikke rekrutterer endnu
- Neutra Life Sciences
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Houston, Texas, Forenede Stater, 77054
- Rekruttering
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, Forenede Stater, 77077
- Rekruttering
- Mercury Clinical Research - Sunrise Pediatrics
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Mesquite, Texas, Forenede Stater, 75149
- Rekruttering
- SMS Clinical Research LLC
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Richmond, Texas, Forenede Stater, 77469
- Ikke rekrutterer endnu
- Pediatric Center- Neutra Life Sciences
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Utah
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Provo, Utah, Forenede Stater, 84604
- Ikke rekrutterer endnu
- AMR Clinical
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Syracuse, Utah, Forenede Stater, 84075
- Ikke rekrutterer endnu
- AMR Clinical
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Virginia
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Richmond, Virginia, Forenede Stater, 23226
- Rekruttering
- Clinical Research Partners, LLC
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Richmond, Virginia, Forenede Stater, 23233
- Ikke rekrutterer endnu
- Tekton Research, LLC.
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Fukui, Japan, 910-0833
- Ikke rekrutterer endnu
- Fukui Aiiku Hospital
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Osaka, Japan, 544-0033
- Ikke rekrutterer endnu
- Kubota Children's Clinic
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Fukuoka
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Fukuoka, Fukuoka, Japan, 814-0121
- Ikke rekrutterer endnu
- Shindo Children's Clinic
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Kasuga, Fukuoka, Japan, 816-0801
- Ikke rekrutterer endnu
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Japan, 062-0907
- Ikke rekrutterer endnu
- Ohigesenseino Kodomo Clinic
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0017
- Ikke rekrutterer endnu
- Futaba Clinic
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Yamanashi
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Kofu, Yamanashi, Japan, 400-0853
- Ikke rekrutterer endnu
- Kose Children Clinic
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Bayamón, Puerto Rico, 00960
- Ikke rekrutterer endnu
- Clinical Research Investigator Group
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Caguas, Puerto Rico, 00726
- Ikke rekrutterer endnu
- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, Puerto Rico, 00725
- Ikke rekrutterer endnu
- Caguas Clinical Research
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Guayama, Puerto Rico, 00784
- Ikke rekrutterer endnu
- Clinical Research Puerto Rico
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Ponce, Puerto Rico, 00716
- Ikke rekrutterer endnu
- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, Puerto Rico, 00717
- Ikke rekrutterer endnu
- BRCR Global Puerto Rico
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San Juan, Puerto Rico, 00907
- Ikke rekrutterer endnu
- BRCR Global Puerto Rico
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Trujillo Alto, Puerto Rico, 00976-3910
- Rekruttering
- San Miguel Medical
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
|
Eksperimentel: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
|
Eksperimentel: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Eksperimentel: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Aktiv komparator: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
20-valent pneumokokkonjugatvaccine (20vPnC)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der rapporterede lokale reaktioner inden for 7 dage efter hver dosis
Tidsramme: Dag 7
|
Fremkaldte lokale reaktioner efter hver dosis
|
Dag 7
|
|
Procentdel af deltagere, der rapporterer alvorlige bivirkninger (SAE)
Tidsramme: Dosis 1 til 6 måneder efter dosis 4
|
SAE, der forekommer fra dosis 1 til 6 måneder efter dosis 4
|
Dosis 1 til 6 måneder efter dosis 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Tidsramme: Day 7
|
Prompted systemic events after each dose
|
Day 7
|
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Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
Tidsramme: Dose 1 to 1 month after Dose 3
|
AEs occurring from Dose 1 to 1 month after Dose 3
|
Dose 1 to 1 month after Dose 3
|
|
Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4
Tidsramme: Dose 4 to 1 month after Dose 4
|
AEs occurring from Dose 4 to 1 month after Dose 4
|
Dose 4 to 1 month after Dose 4
|
|
Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3
|
1 month after Dose 3
|
|
Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Pneumococcal IgG GMCs 1 month after Dose 3
|
1 month after Dose 3
|
|
Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Pneumococcal serotype 3 IgG concentrations 1 month after Dose 3
|
1 month after Dose 3
|
|
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
|
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
Tidsramme: 1 month after Dose 3
|
Differences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3
|
1 month after Dose 3
|
|
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4
|
1 month after Dose 4
|
|
Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Pneumococcal OPA titers 1 month after Dose 3
|
1 month after Dose 3
|
|
Pneumococcal OPA titers prior to Dose 4
Tidsramme: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Pneumococcal OPA titers 1 month after Dose 4
|
1 month after Dose 4
|
|
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4
|
1 month after Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Pneumococcal IgG concentrations 1 month after Dose 3
|
1 month after Dose 3
|
|
Pneumococcal IgG concentrations prior to Dose 4
Tidsramme: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Tidsramme: 1 month after Dose 4
|
Pneumococcal IgG concentrations 1 month after Dose 4
|
1 month after Dose 4
|
|
IgG geometric mean fold rise (GMFR) from before Dose 4 to 1 month after Dose 4
Tidsramme: Before Dose 4 to 1 month after Dose 4
|
IgG GMFR from before Dose 4 to 1 month after Dose 4
|
Before Dose 4 to 1 month after Dose 4
|
|
IgG GMFR from 1 month after Dose 3 to 1 month after Dose 4
Tidsramme: 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
|
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
Tidsramme: 1 month after Dose 3
|
Prespecified antibody levels to specific concomitant vaccine antigens 1 month after Dose 3
|
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
Tidsramme: 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
|
1 month after Dose 4
|
|
Geometric mean of immunoglobulin A (IgA) antibody levels to rotavirus 1 month after Dose 3
Tidsramme: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C4931008
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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