- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Pfizer CT.gov Call Center
- Numero di telefono: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Luoghi di studio
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Fukui, Giappone, 910-0833
- Non ancora reclutamento
- Fukui Aiiku Hospital
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Osaka, Giappone, 544-0033
- Non ancora reclutamento
- Kubota Children's Clinic
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Fukuoka
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Fukuoka, Fukuoka, Giappone, 814-0121
- Non ancora reclutamento
- Shindo children's clinic
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Kasuga, Fukuoka, Giappone, 816-0801
- Non ancora reclutamento
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Giappone, 062-0907
- Non ancora reclutamento
- Ohigesenseino Kodomo Clinic
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Tokyo
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Shinjuku-ku, Tokyo, Giappone, 160-0017
- Non ancora reclutamento
- Futaba Clinic
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Yamanashi
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Kofu, Yamanashi, Giappone, 400-0853
- Non ancora reclutamento
- Kose Children Clinic
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Bayamón, Porto Rico, 00960
- Non ancora reclutamento
- Clinical Research Investigator Group
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Caguas, Porto Rico, 00726
- Non ancora reclutamento
- San Juan Bautista School of Medicine - Clinical Research Unit
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Caguas, Porto Rico, 00725
- Non ancora reclutamento
- Caguas Clinical Research
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Guayama, Porto Rico, 00784
- Non ancora reclutamento
- Clinical Research Puerto Rico
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Ponce, Porto Rico, 00716
- Non ancora reclutamento
- Ponce Medical School Foundation Inc./ CAIMED Center
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Ponce, Porto Rico, 00717
- Non ancora reclutamento
- BRCR Global Puerto Rico
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San Juan, Porto Rico, 00907
- Non ancora reclutamento
- BRCR Global Puerto Rico
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Trujillo Alto, Porto Rico, 00976-3910
- Reclutamento
- San Miguel Medical
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Alabama
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Birmingham, Alabama, Stati Uniti, 35205
- Reclutamento
- Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
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Arkansas
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Fayetteville, Arkansas, Stati Uniti, 72703
- Non ancora reclutamento
- Northwest Arkansas Pediatric Clinic
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Jonesboro, Arkansas, Stati Uniti, 72401
- Non ancora reclutamento
- The Children's Clinic of Jonesboro, P.A.
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California
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Arcadia, California, Stati Uniti, 91007
- Non ancora reclutamento
- San Gabriel Woman's Health
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El Monte, California, Stati Uniti, 91731
- Non ancora reclutamento
- Family Medical Clinic
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Fresno, California, Stati Uniti, 93704
- Reclutamento
- Clinical Research of Central California
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Montebello, California, Stati Uniti, 90640
- Non ancora reclutamento
- SeraCollection Research Services, LLC
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Palo Alto, California, Stati Uniti, 94304
- Non ancora reclutamento
- Stanford University Medical Center CTRU - 800 Welch Road
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Florida
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Homestead, Florida, Stati Uniti, 33030
- Reclutamento
- C & R Research Services USA
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Miami, Florida, Stati Uniti, 33143
- Reclutamento
- Florida Pharmaceutical Research and Associates, Inc.
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Miami, Florida, Stati Uniti, 33155
- Non ancora reclutamento
- BioResearch Partner
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Miami, Florida, Stati Uniti, 33155
- Non ancora reclutamento
- Gold Coast Health Research Center, LLC
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Miami, Florida, Stati Uniti, 33173
- Non ancora reclutamento
- Dade Research Center
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Miami, Florida, Stati Uniti, 33183
- Non ancora reclutamento
- Vasconcello-Cohen MD Research, LLC.
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Miami Lakes, Florida, Stati Uniti, 33014
- Non ancora reclutamento
- Riveldi and Associates
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North Lauderdale, Florida, Stati Uniti, 33068
- Reclutamento
- Eminent Clinical Research and Associates
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Sweetwater, Florida, Stati Uniti, 33182
- Non ancora reclutamento
- Cordova Research Institute LLC
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Georgia
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Norcross, Georgia, Stati Uniti, 30093
- Reclutamento
- Altruistic Clinical Research Global
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Idaho
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Ammon, Idaho, Stati Uniti, 83406
- Non ancora reclutamento
- Medical Research Partners
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Boise, Idaho, Stati Uniti, 83702
- Non ancora reclutamento
- ASR, LLC
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Illinois
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Moline, Illinois, Stati Uniti, 61265
- Non ancora reclutamento
- MidValley Research, Inc
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Iowa
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Ankeny, Iowa, Stati Uniti, 50023
- Non ancora reclutamento
- The Iowa Clinic.
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West Des Moines, Iowa, Stati Uniti, 50265
- Non ancora reclutamento
- Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC)
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Kansas
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Derby, Kansas, Stati Uniti, 67037
- Non ancora reclutamento
- Integrity Clinical Network, LLC
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Louisiana
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Haughton, Louisiana, Stati Uniti, 71037
- Reclutamento
- ACC Pediatric Research
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Maryland
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Columbia, Maryland, Stati Uniti, 21045
- Non ancora reclutamento
- Kur Research, LLC
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Michigan
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Allen Park, Michigan, Stati Uniti, 48101
- Non ancora reclutamento
- Michigan Institute of Research
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Bingham Farms, Michigan, Stati Uniti, 48025
- Non ancora reclutamento
- Michigan Center of Medical Research
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Nebraska
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Grand Island, Nebraska, Stati Uniti, 68803
- Non ancora reclutamento
- Velocity Clinical Research, Grand Island
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Lincoln, Nebraska, Stati Uniti, 68516
- Reclutamento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Stati Uniti, 68522
- Reclutamento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Stati Uniti, 68504
- Non ancora reclutamento
- Midwest Children's Health Research Institute
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Lincoln, Nebraska, Stati Uniti, 68505
- Non ancora reclutamento
- Midwest Children's Health Research Institute
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New York
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Rochester, New York, Stati Uniti, 14642
- Non ancora reclutamento
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, Stati Uniti, 27703
- Reclutamento
- Duke Vaccine and Trials Unit
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Durham, North Carolina, Stati Uniti, 27704
- Reclutamento
- Durham Pediatrics at North Duke Street
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Wilmington, North Carolina, Stati Uniti, 28405
- Non ancora reclutamento
- Wilmington Health
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45245
- Non ancora reclutamento
- Pediatric Associates of Mt. Carmel
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Dayton, Ohio, Stati Uniti, 45429
- Non ancora reclutamento
- PriMED Clinical Research
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South Euclid, Ohio, Stati Uniti, 44121
- Reclutamento
- Senders Pediatrics
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Pennsylvania
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Erie, Pennsylvania, Stati Uniti, 16506
- Non ancora reclutamento
- Allegheny Health and Wellness Pavilion
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South Carolina
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Simpsonville, South Carolina, Stati Uniti, 29680
- Reclutamento
- Tribe Clinical Research LLC. at Parkside Pediatrics Harrison Bridge Road
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Tennessee
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Tullahoma, Tennessee, Stati Uniti, 37388
- Non ancora reclutamento
- Pediatric Clinical Trials of Tennessee, LLC
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Texas
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Brownsville, Texas, Stati Uniti, 78520
- Non ancora reclutamento
- Proactive RGV
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Edinburg, Texas, Stati Uniti, 78539
- Non ancora reclutamento
- Proactive Clinical Research LLC
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El Paso, Texas, Stati Uniti, 79902
- Non ancora reclutamento
- Proactive El Paso,LLC
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Houston, Texas, Stati Uniti, 77065
- Non ancora reclutamento
- Kool Kids Pediatrics
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Houston, Texas, Stati Uniti, 77090
- Non ancora reclutamento
- Houston Clinical Research Associates
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Houston, Texas, Stati Uniti, 77087
- Reclutamento
- Mercury Clinical Research - Pediatric Associates
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Houston, Texas, Stati Uniti, 77042
- Non ancora reclutamento
- Neutra Life Sciences
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Houston, Texas, Stati Uniti, 77054
- Reclutamento
- Mercury Clinical Research (Administrative Office)
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Houston, Texas, Stati Uniti, 77077
- Reclutamento
- Mercury Clinical Research - Sunrise Pediatrics
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Mesquite, Texas, Stati Uniti, 75149
- Reclutamento
- SMS Clinical Research LLC
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Richmond, Texas, Stati Uniti, 77469
- Non ancora reclutamento
- Pediatric Center- Neutra Life Sciences
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Utah
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Provo, Utah, Stati Uniti, 84604
- Non ancora reclutamento
- AMR Clinical
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Syracuse, Utah, Stati Uniti, 84075
- Non ancora reclutamento
- AMR Clinical
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Virginia
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Richmond, Virginia, Stati Uniti, 23226
- Reclutamento
- Clinical Research Partners, LLC
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Richmond, Virginia, Stati Uniti, 23233
- Non ancora reclutamento
- Tekton Research, LLC.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Group 1 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparatore attivo: Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
|
|
Sperimentale: Group 2 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparatore attivo: Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
|
|
Sperimentale: Group 3 PG4 (intramuscular)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Sperimentale: Group 3 PG4 (subcutaneous)
Multivalent Pneumococcal Vaccine
|
Multivalent Pneumococcal Vaccine
|
|
Comparatore attivo: Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)
20-valent pneumococcal conjugate vaccine (20vPnC)
|
Vaccino pneumococcico coniugato 20-valente (20vPnC)
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentuale di partecipanti che hanno segnalato reazioni locali entro 7 giorni dopo ciascuna dose
Lasso di tempo: Giorno 7
|
Reazioni locali sollecitate dopo ogni dose
|
Giorno 7
|
|
Percentuale di partecipanti che hanno segnalato eventi avversi gravi (SAE)
Lasso di tempo: Dose da 1 a 6 mesi dopo la Dose 4
|
SAE che si verificano dalla Dose 1 a 6 mesi dopo la Dose 4
|
Dose da 1 a 6 mesi dopo la Dose 4
|
|
Percentage of participants reporting systemic events within 7 days after each dose
Lasso di tempo: Day 7
|
Prompted systemic events after each dose
|
Day 7
|
|
Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 month after Dose 4
|
Pneumococcal IgG GMCs 1 month after Dose 4
|
1 month after Dose 4
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pneumococcal IgG GMCs 1 month after Dose 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Prior to Dose 4
|
Pneumococcal OPA titers prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal OPA titers 1 month after Dose 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Prior to Dose 4
|
Pneumococcal IgG concentrations prior to Dose 4
|
Prior to Dose 4
|
|
Pneumococcal IgG concentrations 1 month after Dose 4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 month after Dose 3
|
Geometric mean of IgA antibody levels to rotavirus 1 month after Dose 3
|
1 month after Dose 3
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Pfizer CT.gov Call Center, Pfizer
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- C4931008
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .