A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005)

Pneumococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531373
• Other study ID #: V114-005
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 15, 2015
• Est. completion date: April 14, 2017

Study information

• Verified date: March 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: April 14, 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• V114 Medium Dose
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
• V114 High Dose
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
• V114 Medium Dose with Alternative Carrier Protein
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
• V114 High Dose with Alternative Carrier Protein
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
• Prevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Rupp R, Hurley D, Grayson S, Li J, Nolan K, McFetridge RD, Hartzel J, Abeygunawardana C, Winters M, Pujar H, Benner P, Musey L. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Va — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adults: Percentage of Participants With an Adverse Event	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
Primary	Infants: Percentage of Participants With an Adverse Event	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)
Primary	Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event	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)
Primary	Infants: Percentage of Participants With a Solicited Injection-site Adverse Event	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
Primary	Infants: Percentage of Participants With a Solicited Systemic Adverse Event	Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.	Up to 14 days after any vaccination
Primary	Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	1 month after Vaccination 3 (Month 5)
Secondary	Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	1 month after vaccination
Secondary	Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies	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
Secondary	Infants: Percentage of Participants With GMC =0.35 µg/mL at 1 Month After Vaccination 3	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	1 month after Vaccination 3 (Month 5)
Secondary	Infants: Percentage of Participants With GMC =0.35 µg/mL Before Vaccination 4	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	Before Vaccination 4 (Month 10-13)
Secondary	Infants: Percentage of Participants With GMC =0.35 µg/mL at 1 Month After Vaccination 4	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	1 month after Vaccination 4 (Month 11-15)
Secondary	Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	Before Vaccination 4 (Month 10-13)
Secondary	Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.	1 month after Vaccination 4 (Month 11-15)