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

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: V114 High Dose; Biological: V114 Medium Dose with Alternative Carrier Protein; Biological: V114 Medium Dose; Biological: V114 High Dose with Alternative Carrier Protein; Biological: Prevnar 13™

• Registration Number: NCT02531373
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-24
• Study Start: 2015-09-15
• Primary Completion: 2017-04-14
• Study Completion: 2017-04-14
• Results First Submitted: 2018-03-16
• Results First Submitted QC: 2018-03-16
• Results First Posted: 2018-04-17
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant: V114 High Dose	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.
Infant: V114 Medium Dose with Alternative Carrier Protein	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.
Adult: V114 High Dose	V114 High Dose	Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.
Adult: V114 Medium Dose with Alternative Carrier Protein	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.
Infant: V114 Medium Dose	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.
Adult: V114 Medium Dose	V114 Medium Dose	Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.
Adult: V114 High Dose with Alternative Carrier Protein	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.
Infant: Prevnar 13™	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.
Infant: V114 High Dose with Alternative Carrier Protein	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.

Primary Outcome Measures

Name	Time	Method
Adults: Percentage of Participants With an Adverse Event	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.
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event	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.
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies	1 month after Vaccination 3 (Month 5)	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Percentage of Participants With a Solicited Systemic Adverse Event	Up to 14 days after any vaccination	Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Infants: Percentage of Participants With an Adverse Event	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.
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event	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.

Secondary Outcome Measures

Name	Time	Method
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3	1 month after Vaccination 3 (Month 5)	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4	Before Vaccination 4 (Month 10-13)	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies	1 month after Vaccination 4 (Month 11-15)	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies	1 month after vaccination	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4	1 month after Vaccination 4 (Month 11-15)	Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies	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.