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

NCT02531373 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: V114-005
• Study Type: interventional
• Target: 338
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumococcal Infections

Outcome Measures

Primary Outcomes (6)

• 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

• 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)

• Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event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)

• 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

• 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

• 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 Outcomes (7)

• Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies

  1 month after vaccination

• Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies

  Baseline and 1 month after vaccination

• Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3

  1 month after Vaccination 3 (Month 5)

• Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4

  Before Vaccination 4 (Month 10-13)

• Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4

  1 month after Vaccination 4 (Month 11-15)

Study Arms (9)

Adult: V114 Medium Dose

EXPERIMENTAL

Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1.

Biological: V114 Medium Dose

Adult: V114 High Dose

EXPERIMENTAL

Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 on Day 1.

Biological: V114 High Dose

Adult: V114 Medium Dose with Alternative Carrier Protein

EXPERIMENTAL

Adult participants will receive a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein on Day 1.

Biological: V114 Medium Dose with Alternative Carrier Protein

Adult: V114 High Dose with Alternative Carrier Protein

EXPERIMENTAL

Adult participants will receive a single 0.5 mL intramuscular injection of high-dose V114 with alternative carrier protein on Day 1.

Biological: V114 High Dose with Alternative Carrier Protein

Infant: V114 Medium Dose

EXPERIMENTAL

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.

Biological: V114 Medium Dose

Infant: V114 High Dose

EXPERIMENTAL

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.

Biological: V114 High Dose

Infant: V114 Medium Dose with Alternative Carrier Protein

EXPERIMENTAL

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.

Biological: V114 Medium Dose with Alternative Carrier Protein

Infant: V114 High Dose with Alternative Carrier Protein

EXPERIMENTAL

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.

Biological: V114 High Dose with Alternative Carrier Protein

Infant: Prevnar 13™

ACTIVE COMPARATOR

Infant participants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12 to 15 months of age.

Biological: Prevnar 13™

Interventions

V114 Medium Dose BIOLOGICAL

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

Adult: V114 Medium Dose; Infant: V114 Medium Dose

V114 High Dose BIOLOGICAL

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

Adult: V114 High Dose; Infant: V114 High Dose

V114 Medium Dose with Alternative Carrier Protein BIOLOGICAL

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

Adult: V114 Medium Dose with Alternative Carrier Protein; Infant: V114 Medium Dose with Alternative Carrier Protein

V114 High Dose with Alternative Carrier Protein BIOLOGICAL

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

Adult: V114 High Dose with Alternative Carrier Protein; Infant: V114 High Dose with Alternative Carrier Protein

Prevnar 13™ BIOLOGICAL

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

Infant: Prevnar 13™

Eligibility Criteria

• Age: 2 Months - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.

  PMID: 30689507 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 24, 2015
• Study Start: September 15, 2015
• Primary Completion: April 14, 2017
• Study Completion: April 14, 2017
• Last Updated: April 2, 2019
• Results First Posted: April 17, 2018

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share