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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

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ClinicalTrials.gov Identifier: NCT02987972
Recruitment Status : Active, not recruiting
First Posted : December 9, 2016
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Lot 1 Biological: V114 Lot 2 Biological: Prevnar 13™ Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : October 18, 2018
Estimated Study Completion Date : October 18, 2018


Arm Intervention/treatment
Experimental: V114 Lot 1
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Biological: V114 Lot 1
Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Other Name: V114-1

Experimental: V114 Lot 2
Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Biological: V114 Lot 2
Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Other Name: V114-2

Active Comparator: Prevnar 13™
Infants will receive a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
Biological: Prevnar 13™
Pneumococcal capsular polysaccharide 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




Primary Outcome Measures :
  1. Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of >=0.35 mcg/mL for the 13 Common Serotypes [ Time Frame: 1 month after Dose 3 (Month 5) ]
    Serotype-specific pneumococcal IgG antibody will be measured using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG >=0.35 mcg/mL will be assessed.

  2. Percentage of Participants with an Adverse Event [ Time Frame: Up to 1 month after Dose 4 (up to 14 months) ]
    An adverse event (AE) is defined as 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 adverse event. The percentage of participants with one or more AEs will be assessed.

  3. Percentage of Participants who Discontinued the Study Due to an Adverse Event [ Time Frame: Up to 1 month after Dose 4 (up to 14 months) ]
    The percentage of participants who discontinued the study because of an AE (as defined above) will be assessed.

  4. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Injection-site AEs solicited on the Vaccine Report Card will be redness, swelling, hard lump, and pain/tenderness. The percentage of participants with one or more solicited injection-site AEs will be assessed.

  5. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to 14 days after any vaccination ]
    Systemic AEs solicited on the Vaccine Report Card will be fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with one or more solicited systemic AEs will be assessed.

  6. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common and the 2 V114-Unique Serotypes [ Time Frame: 1 month after Dose 3 (Month 5) ]
    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay. The geometric mean concentration of serotype-specific IgG will be assessed.


Secondary Outcome Measures :
  1. Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody [ Time Frame: Before Dose 4 (Month 10 to 13) and 1 month after Dose 4 (Month 11 to 14) ]
    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery MSD Pn electrochemiluminescence assay. The geometric mean concentration of serotype-specific IgG will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infant approximately 2 months of age (42 days to 90 days), inclusive
  • In good health

Exclusion Criteria:

  • Prior administration of any pneumococcal vaccine
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any diphtheria toxoid-containing vaccine
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency (eg, splenomegaly)
  • Mother has documented human immunodeficiency virus (HIV) infection
  • Mother has documented hepatitis B surface antigen-positive test result
  • Known or history of functional or anatomic asplenia
  • History of failure to thrive
  • History of a coagulation disorder
  • History of autoimmune disease
  • Known neurologic or cognitive behavioral disorder
  • Expects to require systemic corticosteroids within 30 days after each vaccination during the trial
  • Prior administration of a blood transfusion or blood products, including immunoglobulin
  • Participated in another clinical trial of an investigational product
  • History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987972


  Show 49 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02987972     History of Changes
Other Study ID Numbers: V114-008
2016-001117-25 ( EudraCT Number )
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs