13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
27 febbraio 2015 aggiornato da: Pfizer
A Phase 3, Randomized, Open-label Trial To Evaluate The Safety, Tolerability And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials Given With Routine Pediatric Vaccinations In Healthy Infants
This study will compare the immune responses of the infants who have been given 13vPnC in the mutidose vial formulation to the immune reponses of the infants who have been given 13vPnC in the single-dose syringe formulation.
It will also evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in all infants who are vaccinated.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
500
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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The Gambia
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Ksmd, The Gambia, Gambia
- Fajikunda Major Health Centre
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The Gambia, West Africa
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Fajara, The Gambia, West Africa, Gambia, 000273
- Medical Research Council Unit, The Gambia
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 mese a 2 mesi (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Aged 42 to 70 days at enrollment.
- Determined by medical history, physical examination, and clinical judgment to be eligible for the study
- Weight of 3.5 kg or greater at the time of enrollment
Exclusion Criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Receipt of blood products or gamma-globulin since birth
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Multidose Vial Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the multidose vial formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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Comparatore attivo: Single-Dose Syringe Group
Subjects will receive three doses of 13-valent pneumococcal conjugate vaccine in the single-dose syringe formulation.
Each dose is 0.5 mL
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Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg.
Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Lasso di tempo: 1 month after the infant series
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Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Lasso di tempo: 1 month after the infant series
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Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated.
Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.
Here "n"= participants with valid and determinate IgG concentration to the given serotype.
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1 month after the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1(Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary.
Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement).
Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm).
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 1 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 2 (Day 2 to Day 6) of infant series
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Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Lasso di tempo: Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed).
Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted).
Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary.
Participants may be represented in more than 1 category.
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Within 5 days after Dose 3 (Day 2 to Day 6) of infant series
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
Lasso di tempo: Dose 1 up to 28 to 42 days after dose 3
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
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Dose 1 up to 28 to 42 days after dose 3
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
Lasso di tempo: Informed consent up to Dose 1
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An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Adverse events were also reported in participants who provided consent but were not randomized in this study.
The data of these participants has been reported under 'Screened Only' arm.
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Informed consent up to Dose 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Lasso di tempo: 1 month after the infant series
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Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13.
Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants.
Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
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1 month after the infant series
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Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Lasso di tempo: 1 month after the infant series
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Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented.
GMTs were calculated using all participants with available data for the specified blood draw.
CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers.
Here "n"= participants evaluable =specified category.
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1 month after the infant series
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2014
Completamento primario (Effettivo)
1 settembre 2014
Completamento dello studio (Effettivo)
1 settembre 2014
Date di iscrizione allo studio
Primo inviato
9 settembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
14 ottobre 2013
Primo Inserito (Stima)
17 ottobre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
13 marzo 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 febbraio 2015
Ultimo verificato
1 febbraio 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- B4671001
- 2012-000482-21 (Numero EudraCT)
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 .
Prove cliniche su 13-valent pneumococcal conjugate vaccine
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The Jackson LaboratoryUniversity of Alabama at Birmingham; UConn HealthCompletatoPolmonite | InvecchiamentoStati Uniti