A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003)

NCT01215188 | Completed Phase 2 Results DMC

• 1 other identifier: V114-003
• Study Type: interventional
• Target: 1,152
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®

Conditions

Pneumococcal Infections

Keywords

Invasive pneumococcal disease; Pneumonia; Pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3

  Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

  One month postvaccination 3

• IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3

  The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

  One month postvaccination 3

• IgG GMCs for Postvaccination 4

  The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.

  One month postvaccination 4

• Number of Participants With an Adverse Event (AE)

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

  Up to Day 14 postvaccination

• Number of Participants With an Injection-site AE

  Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

  Up to Day 14 postvaccination

• Number of Participants With a Systemic AE

  Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.

  Up to Day 14 postvaccination

• Number of Participants With a Serious Adverse Event (SAE)

  An 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 one month after last dose of study vaccine

• Number of Participants Who Discontinued the Study Due to an AE

  An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.

  Up to Day 14 postvaccination

Secondary Outcomes (6)

• Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3

  One month postvaccination 3

• Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4

  One month postvaccination 4

• OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3

  One month postvaccination 3

• OPA GMTs as Measured by MOPA4 for Postvaccination 4

  One month postvaccination 4

• Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4

  One month postvaccination 4

Study Arms (3)

V114 Aluminum-adjuvanted

EXPERIMENTAL

Four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.

Biological: V114 Aluminum-adjuvanted

V114 Non-adjuvanted

EXPERIMENTAL

Four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.

Biological: V114 Non-adjuvanted

Prevnar 13®

ACTIVE COMPARATOR

Four IM doses at 0.5 mL of Prevnar 13® at 2, 4, 6, and 12 to 15 months of age.

Biological: Prevnar 13®

Interventions

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 (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

V114 Aluminum-adjuvanted

V114 Non-adjuvanted BIOLOGICAL

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.

V114 Non-adjuvanted

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 each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.

Prevnar 13®

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants ≥ 42 days to ≤ 89 days.
• Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child 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:

• Prior administration of any pneumococcal vaccine.
• Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
• Known or suspected impairment of immunological function.
• Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
• Participant or his/her mother has documented human immunodeficiency virus (HIV) infection.
• Functional or anatomic asplenia.
• Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
• Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. 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.
• Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine.
• Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine.
• Prior receipt of a blood transfusion or blood products, including immunoglobulins.
• Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
• Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
• History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• A recent febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\]) occurring within 72 hours before receipt of study vaccine.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Greenberg D, Hoover PA, Vesikari T, Peltier C, Hurley DC, McFetridge RD, Dallas M, Hartzel J, Marchese RD, Coller BG, Stek JE, Abeygunawardana C, Winters MA, MacNair JE, Pujar NS, Musey L. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018 Oct 29;36(45):6883-6891. doi: 10.1016/j.vaccine.2018.02.113. Epub 2018 Sep 21.

  PMID: 30244873 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections; Pneumonia

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: October 14, 2010
• Primary Completion: July 31, 2012
• Study Completion: July 31, 2012
• Last Updated: April 30, 2019
• Results First Posted: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share