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A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03620162
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunization schedule.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Prevnar 13™ Biological: V114 Biological: RotaTeq™ Biological: Pentacel™ Biological: Recombivax HB™ Biological: Hiberix™ Biological: M-M-R™ II Biological: Varivax™ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : December 11, 2020
Estimated Study Completion Date : December 11, 2020


Arm Intervention/treatment
Active Comparator: Group 1: Prevnar 13™
Participants will receive a single 0.5 mL intramuscular (IM) injection of double-blind Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
Biological: Prevnar 13™
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

Biological: RotaTeq™
RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Pentacel™
Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Recombivax HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Hiberix™
HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: M-M-R™ II
M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Varivax™
VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Experimental: Group 2: Prevnar 13™ Switch to V114 at Dose 4
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4) and double-blind V114 at approximately 12-15 months of age (Study Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
Biological: Prevnar 13™
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

Biological: V114
V114 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

Biological: RotaTeq™
RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Pentacel™
Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Recombivax HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Hiberix™
HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: M-M-R™ II
M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Varivax™
VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Experimental: Group 3: Prevnar 13™ Switch to V114 at Dose 3
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 and 4 months of age (Study Day 1 and Month 2) and double-blind V114 at approximately 6 and 12-15 months of age (Study Month 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
Biological: Prevnar 13™
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

Biological: V114
V114 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

Biological: RotaTeq™
RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Pentacel™
Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Recombivax HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Hiberix™
HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: M-M-R™ II
M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Varivax™
VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Experimental: Group 4: Prevnar 13™ Switch to V114 at Dose 2
Participants will receive a single 0.5 mL IM injection of double-blind Prevnar 13™ at approximately 2 months of age (Study Day 1) and double-blind V114 at approximately 4, 6 and 12-15 months of age (Study Month 2, 4 and 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
Biological: Prevnar 13™
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

Biological: V114
V114 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

Biological: RotaTeq™
RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Pentacel™
Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Recombivax HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Hiberix™
HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: M-M-R™ II
M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Varivax™
VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Experimental: Group 5: V114
Participants will receive a single 0.5 mL IM injection of double-blind V114 at approximately 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13). Other licensed pediatric vaccines will be administered open-label concomitantly with the study vaccines according to the recommended schedule: RotaTeq™, Pentacel™, and Recombivax HB™ at approximately 2, 4, and 6 months of age (Study Day 1, Month 2, and Month 4), and Hiberix™, M-M-R™ II, and Varivax™ at approximately 12-15 months of age (Study Month 10-13).
Biological: V114
V114 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

Biological: RotaTeq™
RotaTeq™ (Rotavirus Vaccine, Live, Oral, Pentavalent)
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Pentacel™
Pentacel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Recombivax HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant) for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Hiberix™
HIBERIX™ [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] for IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: M-M-R™ II
M-M-R™ II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE) for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Biological: Varivax™
VARIVAX™ Varicella Virus Vaccine Live for subcutaneous injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Name: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to 14 days after each Prevnar 13™ and V114 vaccination ]
    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 AE. Injection-site AEs solicited on the Vaccination Report Card are swelling, redness, pain or tenderness, and hard lump.

  2. Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to 14 days after each Prevnar 13™ and V114 vaccination ]
    An 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 AE. Systemic AEs solicited on the Vaccination Report Card are irritability, drowsiness, appetite loss, and hives or welts.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to 6 months after Dose 4 (Study Month 19) ]
    A serious adverse event (SAE) is an AE that 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. Relatedness of an SAE to the study vaccine will be determined by the investigator.

  4. Geometric Mean Concentration of Immunoglobulin G (IgG) Serotypes Contained in V114: Groups 2, 3, and 4 versus Group 1 [ Time Frame: 1 month after Dose 4 (approximately Study Month 11-14) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. This Outcome Measure will compare immune response in Groups 2, 3, and 4 versus Group 1.


Secondary Outcome Measures :
  1. Percentage of Participants with anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL [ Time Frame: 1 month after Dose 3 (Study Month 5) ]
    Concentration of anti-HBsAg antibody will be determined using the hepatitis B enhanced chemiluminescence (ECi) assay. The unit of measure of the ECi is milli International Units/mL (mIU/mL).

  2. Geometric Mean Titer (GMT) of anti-Rotavirus Immunoglobulin A (IgA) [ Time Frame: 1 month after Dose 3 (Study Month 5) ]
    Anti-Rotavirus IgA will be determined using an enzyme-linked immunosorbent assay (EIA).

  3. Geometric Mean Concentration of IgG Serotypes Contained in V114 [ Time Frame: 1 month after Dose 3 (Study Month 5) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  4. Percentage of Participants with IgG Concentration ≥0.35 mcg/mL for Serotypes Contained in V114 [ Time Frame: 1 month after Dose 3 (Study Month 5) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay.

  5. Geometric Mean Concentration of IgG Serotypes Contained in V114: Group 5 versus Group 1 [ Time Frame: 1 month after Dose 4 (approximately Study Month 11-14) ]
    Immunoglobulin G for the 15 serotypes contained in V114 vaccine will be determined using an electrochemiluminescence assay. This Outcome Measure will compare immune response in Group 5 versus Group 1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   42 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, based on clinical judgment of the investigator
  • Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

  • 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
  • Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine
  • Any contraindication to the concomitant study vaccines being administered in the study
  • Known or suspected impairment of immunological function
  • History of congenital or acquired immunodeficiency
  • Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
  • Has or his/her mother has a documented hepatitis B surface antigen - positive test
  • Known or history of functional or anatomic asplenia
  • Failure to thrive based on the clinical judgment of the investigator
  • Known coagulation disorder contraindicating intramuscular vaccination
  • History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
  • Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Received a dose of any pneumococcal vaccine prior to study entry
  • Received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Received a dose of rotavirus vaccine prior to study entry
  • Received a blood transfusion or blood products, including immunoglobulins
  • Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study
  • Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
  • Has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

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): NCT03620162


  Show 34 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03620162     History of Changes
Other Study ID Numbers: V114-027
V114-027 ( Other Identifier: Merck Protocol Number )
2018-001151-12 ( EudraCT Number )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs