- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02531373
A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
21 marzo 2019 aggiornato da: Merck Sharp & Dohme LLC
A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
338
Fase
- Fase 2
- Fase 1
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 2 mesi a 49 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
Adult Cohort: 18 to 49 years and in good health
- Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine.
Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
Exclusion Criteria:
Adult cohort: Prior administration of any pneumococcal vaccine
- History of invasive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- Coagulation disorder contraindicating intramuscular vaccination
- Received a blood transfusion or blood products within 6 months
- Participated in another clinical study of an investigational product within 2 months
- Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine
- Known hypersensitivity to any vaccine component
- Known or suspected impairment of immune function
- History of congenital or acquired immunodeficiency
- Has or mother has documented Human Immunodeficiency virus (HIV) infection
- Has or mother has documented hepatitis B surface antigen positive result
- Functional or anatomic asplenia
- History of failure to thrive
- Coagulation disorder contraindicating intramuscular vaccination
- History of autoimmune disease or autoimmune disorder
- Known neurologic or cognitive behavioral disorder
- Received systemic corticosteroids within 14 days
- Received other licensed non-live vaccine within 14 days
- Received other licensed live virus vaccine within 30 days
- Received a blood transfusion or blood products
- Participated in another clinical study of an investigational product
- History of invasive pneumococcal disease
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: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Adult: V114 Medium Dose
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
|
Sperimentale: Adult: V114 High Dose
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
|
Sperimentale: Adult: V114 Medium Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
|
Sperimentale: Adult: V114 High Dose with Alternative Carrier Protein
Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
|
Sperimentale: Infant: V114 Medium Dose
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
|
Sperimentale: Infant: V114 High Dose
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
|
Sperimentale: Infant: V114 Medium Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
|
Sperimentale: Infant: V114 High Dose with Alternative Carrier Protein
Infant participants will receive a 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein at 2, 4, 6, and 12 to 15 months of age.
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
|
Comparatore attivo: Infant: Prevnar 13™
Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.
|
Vaccino coniugato pneumococcico 13-valente con sierotipi 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2,2 mcg) e 6B (4,4 mcg) in ciascuna dose da 0,5 ml
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Adults: Percentage of Participants With an Adverse Event
Lasso di tempo: Up to 6 weeks after vaccination
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to 6 weeks after vaccination
|
Infants: Percentage of Participants With an Adverse Event
Lasso di tempo: Up to 1 month after Vaccination 4 (Month 11-15)
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to 1 month after Vaccination 4 (Month 11-15)
|
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event
Lasso di tempo: Up to time of Vaccination 4 (Month 10-13)
|
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
|
Up to time of Vaccination 4 (Month 10-13)
|
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Lasso di tempo: Up to 14 days after any vaccination
|
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
|
Up to 14 days after any vaccination
|
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Lasso di tempo: Up to 14 days after any vaccination
|
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
|
Up to 14 days after any vaccination
|
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Lasso di tempo: 1 month after Vaccination 3 (Month 5)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 3 (Month 5)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Lasso di tempo: 1 month after vaccination
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after vaccination
|
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Lasso di tempo: Baseline and 1 month after vaccination
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
|
Baseline and 1 month after vaccination
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Lasso di tempo: 1 month after Vaccination 3 (Month 5)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 3 (Month 5)
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Lasso di tempo: Before Vaccination 4 (Month 10-13)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
Before Vaccination 4 (Month 10-13)
|
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Lasso di tempo: 1 month after Vaccination 4 (Month 11-15)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 4 (Month 11-15)
|
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Lasso di tempo: Before Vaccination 4 (Month 10-13)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
Before Vaccination 4 (Month 10-13)
|
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Lasso di tempo: 1 month after Vaccination 4 (Month 11-15)
|
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
|
1 month after Vaccination 4 (Month 11-15)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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 (Effettivo)
15 settembre 2015
Completamento primario (Effettivo)
14 aprile 2017
Completamento dello studio (Effettivo)
14 aprile 2017
Date di iscrizione allo studio
Primo inviato
20 agosto 2015
Primo inviato che soddisfa i criteri di controllo qualità
20 agosto 2015
Primo Inserito (Stima)
24 agosto 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 aprile 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 marzo 2019
Ultimo verificato
1 marzo 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- V114-005
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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 .
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