A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)
21 mars 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
338
Fas
- Fas 2
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 månader till 49 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Experimentell: 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
|
|
Aktiv komparator: 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.
|
13-valent pneumokockkonjugatvaccin med serotyperna 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2,2 mcg) och 6B (4,4 mcg) i varje 0,5 ml dos
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adults: Percentage of Participants With an Adverse Event
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 september 2015
Primärt slutförande (Faktisk)
14 april 2017
Avslutad studie (Faktisk)
14 april 2017
Studieregistreringsdatum
Först inskickad
20 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2015
Första postat (Uppskatta)
24 augusti 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- V114-005
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .