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

January 12, 2023 updated by: Merck Sharp & Dohme LLC

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)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Cooperativa de Facultad Medica Sanacoop ( Site 0057)
      • Guayama, Puerto Rico, 00784
        • Clinical Research of Puerto Rico ( Site 0050)
      • Ponce, Puerto Rico, 00716
        • CAIMED Center - Ponce School of Medicine ( Site 0053)
      • San Juan, Puerto Rico, 00935
        • San Juan Hospital ( Site 0056)
      • San Juan, Puerto Rico, 00935
        • University of Puerto Rico ( Site 0051)
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University ( Site 0092)
      • Bangkok, Thailand, 10700
        • Siriaj Hospital ( Site 0091)
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital ( Site 0090)
    • Khon Kaen
      • Muang, Khon Kaen, Thailand, 40002
        • Srinagarind Hospital. Khon Kaen University ( Site 0093)
  • Turkey
      • Ankara, Turkey, 06230
        • Hacettepe University Faculty of Medicine ( Site 0070)
      • Eskisehir, Turkey, 26480
        • Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)
      • Izmir, Turkey, 35040
        • Ege University Medical Faculty Hospital ( Site 0072)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Alabama Clinical Therapeutics ( Site 0015)
      • Dothan, Alabama, United States, 36305
        • Southeastern Pediatric Associates, P.A. ( Site 0002)
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Children's Clinic of Jonesboro, PA ( Site 0022)
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
        • Davita Medical Group ( Site 0012)
    • Florida
      • Miami, Florida, United States, 33184
        • Suncoast Research Associates, LLC ( Site 0035)
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric/Adult Research Inc ( Site 0011)
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Pediatric Associates of Fall River ( Site 0021)
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute, LLC ( Site 0024)
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute, LLC ( Site 0003)
      • Lincoln, Nebraska, United States, 68516
        • Midwest Children's Health Research Institute, LLC ( Site 0004)
      • Lincoln, Nebraska, United States, 68522
        • Midwest Children's Health Research Institute, LLC ( Site 0001)
    • New York
      • Liverpool, New York, United States, 13088
        • Summerwood Pediatrics ( Site 0009)
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center ( Site 0029)
      • Syracuse, New York, United States, 13202
        • SUNY Upstate Medical University ( Site 0008)
    • North Carolina
      • Statesville, North Carolina, United States, 28625
        • Piedmont Healthcare, PA ( Site 0025)
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research ( Site 0006)
      • Greenville, South Carolina, United States, 29607
        • Parkside Pediatric ( Site 0007)
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group ( Site 0018)
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group LLC ( Site 0017)
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch ( Site 0023)
    • Utah
      • Murray, Utah, United States, 84107
        • Wasatch Pediatrics-Cottonwood Office ( Site 0014)
    • Washington
      • Spokane, Washington, United States, 99202
        • Multicare ( Site 0019)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Is 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:

  • Has a 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
  • Has a 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
  • Has any contraindication to the concomitant study vaccines being administered in the study
  • Has a known or suspected impairment of immunological function
  • Has a 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
  • Has known or history of functional or anatomic asplenia
  • Has failure to thrive based on the clinical judgment of the investigator
  • Has a known coagulation disorder contraindicating intramuscular vaccination
  • Has a 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)
  • Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
  • Has received a dose of any pneumococcal vaccine prior to study entry
  • Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Has received a dose of rotavirus vaccine prior to study entry
  • Has received a blood transfusion or blood products, including immunoglobulins
  • Has 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™
Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other Names:
  • V260; 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, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Experimental: Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other Names:
  • V260; 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, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: V114
V114 contains the 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 given via IM injection.
Other Names:
  • VAXNEUVANCE™
Experimental: Group 3: Prevnar 13™-Prevnar 13™-V114-V114
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other Names:
  • V260; 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, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: V114
V114 contains the 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 given via IM injection.
Other Names:
  • VAXNEUVANCE™
Experimental: Group 4: Prevnar 13™-V114-V114-V114
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
Biological: Prevnar 13™
Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other Names:
  • V260; 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, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: V114
V114 contains the 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 given via IM injection.
Other Names:
  • VAXNEUVANCE™
Experimental: Group 5: V114-V114-V114-V114
Participants will receive a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants will concomitantly receive other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13.
Biological: RotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
Other Names:
  • V260; 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, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: RECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V232, HEPTAVAX™-II, HBVAXPRO; 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), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • 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), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: VARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Other Names:
  • V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.
Biological: V114
V114 contains the 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 given via IM injection.
Other Names:
  • VAXNEUVANCE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Time Frame: Up to ~14 days after each vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to ~14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
Up to ~14 days after each vaccination
Percentage of Participants With a Solicited Systemic AE
Time Frame: Up to ~14 days after each vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to ~14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.
Up to ~14 days after each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
Time Frame: Up to ~6 months after Vaccination 4 (up to ~19 months)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.
Up to ~6 months after Vaccination 4 (up to ~19 months)
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Time Frame: 30 Days after Vaccination 4 (Months 11-14)
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.
30 Days after Vaccination 4 (Months 11-14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3
Time Frame: 30 Days after Vaccination 3 (Month 5)
The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol.
30 Days after Vaccination 3 (Month 5)
Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3
Time Frame: 30 Days after Vaccination 3 (Month 5)
The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol.
30 Days after Vaccination 3 (Month 5)
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Time Frame: 30 Days after Vaccination 3 (Month 5)
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3.
30 Days after Vaccination 3 (Month 5)
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
Time Frame: 30 Days after Vaccination 3 (Month 5)
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ [1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F] and 2 unique serotypes [22F, 33F]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.
30 Days after Vaccination 3 (Month 5)
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
Time Frame: 30 Days after Vaccination 4 (Months 11-14)
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record.
30 Days after Vaccination 4 (Months 11-14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2018

Primary Completion (Actual)

December 14, 2020

Study Completion (Actual)

December 14, 2020

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V114-027 (Other Identifier: Merck)
  • 2018-001151-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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