Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

NCT01215175 | Completed Phase 1 Results DMC

• 2 other identifiers: V114-0012009-015103-58
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal vaccines

Outcome Measures

Primary Outcomes (6)

• Adult: Percentage of Participants With Any 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 Day 14 after vaccination

• Toddler: Percentage of Participants With Any 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 Day 14 after vaccination

• Adult: Percentage of Participants With Any Serious Adverse Event

  A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  Up to Day 14 after vaccination

• Toddler: Percentage of Participants With Any Serious Adverse Event

  A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.

  Up to Day 14 after vaccination

• Adult: Percentage of Participants With Any Vaccine-related 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. Relatedness of the AE to study vaccine was determined by the investigator.

  Up to Day 14 after vaccination

• Toddler: Percentage of Participants With Any Vaccine-related 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. Relatedness of the AE to study vaccine was determined by the investigator.

  Up to Day 14 after vaccination

Secondary Outcomes (8)

• Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL

  Day 30 after vaccination

• Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL

  Day 30 after vaccination

• Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies

  Day 30 after vaccination

• Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies

  Day 30 after vaccination

• Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8

  Day 30 after vaccination

Study Arms (5)

Prevnar™ - Adult Cohort

ACTIVE COMPARATOR

Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.

Biological: Prevnar™

V114 Adjuvanted -Toddler Cohort

EXPERIMENTAL

Healthy toddler (12-15 months of age) participants who had completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Biological: V114, Aluminum Adjuvanted

V114 Nonadjuvanted-Toddler Cohort

EXPERIMENTAL

Healthy toddlers (12-15 months of age) participants who completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of non-adjuvanted V114 on Day 1.

Biological: V114, Aluminum Nonadjuvanted

Prevnar™- Toddler Cohort

ACTIVE COMPARATOR

Healthy toddlers (12-15 months of age) participants who had previously completed a documented full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1.

Biological: Prevnar™

V114 Adjuvanted -Adult Cohort

EXPERIMENTAL

Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1.

Biological: V114, Aluminum Adjuvanted

Interventions

Prevnar™ BIOLOGICAL

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

Prevnar™ - Adult Cohort; Prevnar™- Toddler Cohort

V114, Aluminum Adjuvanted BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114 Adjuvanted -Adult Cohort; V114 Adjuvanted -Toddler Cohort

V114, Aluminum Nonadjuvanted BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.

V114 Nonadjuvanted-Toddler Cohort

Eligibility Criteria

• Age: 12 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult Stage:
• Adults ≥18 to 45 years of age in good health.
• Signed and dated informed consent prior to receipt of vaccine.
• Afebrile (\<100.4°F \[\<38.0°C\] oral or equivalent) on day of vaccination.
• Participant is able to read, understand, and complete study questionnaires (i.e., the Vaccine Report Card).
• Participant is able to attend all scheduled visits and to comply with the study procedures.
• Participant has access to a telephone.
• Females must have a negative urine pregnancy test.
• Toddler Stage:
• Healthy toddlers, 12-15 months of age who have previously completed a documented full 3 dose infant series of Prevnar™ at 2, 4, and 6 months of age.
• Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
• Afebrile, with a rectal temperature \<38.1°C (\<100.5°F) or axillary temperature \<37.8°C (\<100.0°F) on day of vaccination.
• Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card).
• Participant is able to attend all scheduled visits and to comply with the study procedures.
• Participant's parent/legal guardian has access to a telephone.

You may not qualify if:

• Adult Stage:
• Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of polysaccharide conjugate vaccine after the second year of life.
• Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
• Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3 mg/dL), nephritic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplant.
• Functional or anatomic asplenia.
• History of chronic fatigue syndrome.
• Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis (ADEM), pervasive developmental disorder, and related disorders.
• Participant has a coagulation disorder contraindicating IM vaccination.
• Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 30 days prior to Visit 1 through Visit 2, systemic doses greater than required for physiological replacement, i.e., \>5 mg of prednisone (or equivalent) daily and for \>2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
• Any underlying illness that would complicate evaluation and completion of this study.
• Any licensed non-live virus vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.)
• Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive vaccination with a licensed live virus vaccine within 30 days of receipt of study vaccine.
• Participant has received diphtheria toxoid within 6 months prior to receipt of study vaccine.
• Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine.
• Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Sobanjo-ter Meulen A, Vesikari T, Malacaman EA, Shapiro SA, Dallas MJ, Hoover PA, McFetridge R, Stek JE, Marchese RD, Hartzel J, Watson WJ, Musey LK. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015 Feb;34(2):186-94. doi: 10.1097/INF.0000000000000516.

  PMID: 25741971 RESULT

• McFetridge R, Meulen AS, Folkerth SD, Hoekstra JA, Dallas M, Hoover PA, Marchese RD, Zacholski DM, Watson WJ, Stek JE, Hartzel JS, Musey LK. Safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2015 Jun 4;33(24):2793-9. doi: 10.1016/j.vaccine.2015.04.025. Epub 2015 Apr 23.

  PMID: 25913828 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Limitations and Caveats

Data related to the IgG antibody response of serotype 22F in the toddler samples were considered experimental due to failure of assay validity criteria.

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: October 4, 2010
• First Posted: October 6, 2010
• Study Start: September 25, 2009
• Primary Completion: April 16, 2010
• Study Completion: January 5, 2011
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share