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

NCT ID: NCT03620162

Last Updated: 2023-01-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2020-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Prevnar 13™

Intervention Type BIOLOGICAL

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.

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™

Intervention Type BIOLOGICAL

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.

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™

Intervention Type BIOLOGICAL

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.

M-M-R™ II

Intervention Type BIOLOGICAL

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.

VARIVAX™

Intervention Type BIOLOGICAL

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

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.

Group Type EXPERIMENTAL

Prevnar 13™

Intervention Type BIOLOGICAL

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.

V114

Intervention Type BIOLOGICAL

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.

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™

Intervention Type BIOLOGICAL

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.

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™

Intervention Type BIOLOGICAL

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.

M-M-R™ II

Intervention Type BIOLOGICAL

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.

VARIVAX™

Intervention Type BIOLOGICAL

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

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.

Group Type EXPERIMENTAL

Prevnar 13™

Intervention Type BIOLOGICAL

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.

V114

Intervention Type BIOLOGICAL

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.

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™

Intervention Type BIOLOGICAL

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.

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™

Intervention Type BIOLOGICAL

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.

M-M-R™ II

Intervention Type BIOLOGICAL

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.

VARIVAX™

Intervention Type BIOLOGICAL

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

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.

Group Type EXPERIMENTAL

Prevnar 13™

Intervention Type BIOLOGICAL

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.

V114

Intervention Type BIOLOGICAL

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.

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™

Intervention Type BIOLOGICAL

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.

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™

Intervention Type BIOLOGICAL

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.

M-M-R™ II

Intervention Type BIOLOGICAL

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.

VARIVAX™

Intervention Type BIOLOGICAL

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

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.

Group Type EXPERIMENTAL

V114

Intervention Type BIOLOGICAL

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.

RotaTeq™

Intervention Type BIOLOGICAL

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Pentacel™

Intervention Type BIOLOGICAL

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.

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

HIBERIX™

Intervention Type BIOLOGICAL

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.

M-M-R™ II

Intervention Type BIOLOGICAL

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.

VARIVAX™

Intervention Type BIOLOGICAL

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

RotaTeq™

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BIOLOGICAL

VARIVAX™

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

Intervention Type BIOLOGICAL

Other Intervention Names

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VAXNEUVANCE™ V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced. V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.

Eligibility Criteria

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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.
Minimum Eligible Age

42 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Alabama Clinical Therapeutics ( Site 0015)

Birmingham, Alabama, United States

Site Status

Southeastern Pediatric Associates, P.A. ( Site 0002)

Dothan, Alabama, United States

Site Status

Children's Clinic of Jonesboro, PA ( Site 0022)

Jonesboro, Arkansas, United States

Site Status

Davita Medical Group ( Site 0012)

Colorado Springs, Colorado, United States

Site Status

Suncoast Research Associates, LLC ( Site 0035)

Miami, Florida, United States

Site Status

Kentucky Pediatric/Adult Research Inc ( Site 0011)

Bardstown, Kentucky, United States

Site Status

Pediatric Associates of Fall River ( Site 0021)

Fall River, Massachusetts, United States

Site Status

Midwest Children's Health Research Institute, LLC ( Site 0024)

Lincoln, Nebraska, United States

Site Status

Midwest Children's Health Research Institute, LLC ( Site 0003)

Lincoln, Nebraska, United States

Site Status

Midwest Children's Health Research Institute, LLC ( Site 0004)

Lincoln, Nebraska, United States

Site Status

Midwest Children's Health Research Institute, LLC ( Site 0001)

Lincoln, Nebraska, United States

Site Status

Summerwood Pediatrics ( Site 0009)

Liverpool, New York, United States

Site Status

University of Rochester Medical Center ( Site 0029)

Rochester, New York, United States

Site Status

SUNY Upstate Medical University ( Site 0008)

Syracuse, New York, United States

Site Status

Piedmont Healthcare, PA ( Site 0025)

Statesville, North Carolina, United States

Site Status

Coastal Pediatric Research ( Site 0006)

Charleston, South Carolina, United States

Site Status

Parkside Pediatric ( Site 0007)

Greenville, South Carolina, United States

Site Status

Holston Medical Group ( Site 0018)

Kingsport, Tennessee, United States

Site Status

Ventavia Research Group LLC ( Site 0017)

Fort Worth, Texas, United States

Site Status

University of Texas Medical Branch ( Site 0023)

Galveston, Texas, United States

Site Status

Wasatch Pediatrics-Cottonwood Office ( Site 0014)

Murray, Utah, United States

Site Status

Multicare ( Site 0019)

Spokane, Washington, United States

Site Status

Cooperativa de Facultad Medica Sanacoop ( Site 0057)

Bayamón, , Puerto Rico

Site Status

Clinical Research of Puerto Rico ( Site 0050)

Guayama, , Puerto Rico

Site Status

CAIMED Center - Ponce School of Medicine ( Site 0053)

Ponce, , Puerto Rico

Site Status

San Juan Hospital ( Site 0056)

San Juan, , Puerto Rico

Site Status

University of Puerto Rico ( Site 0051)

San Juan, , Puerto Rico

Site Status

Srinagarind Hospital. Khon Kaen University ( Site 0093)

Muang, Changwat Khon Kaen, Thailand

Site Status

Chulalongkorn University ( Site 0092)

Bangkok, , Thailand

Site Status

Siriaj Hospital ( Site 0091)

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital ( Site 0090)

Chiang Mai, , Thailand

Site Status

Hacettepe University Faculty of Medicine ( Site 0070)

Ankara, , Turkey (Türkiye)

Site Status

Eskisehir Osmangazi University Faculty of Medicine ( Site 0071)

Eskişehir, , Turkey (Türkiye)

Site Status

Ege University Medical Faculty Hospital ( Site 0072)

Izmir, , Turkey (Türkiye)

Site Status

Countries

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United States Puerto Rico Thailand Turkey (Türkiye)

References

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Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13.

Reference Type RESULT
PMID: 36522265 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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V114-027

Identifier Type: OTHER

Identifier Source: secondary_id

2018-001151-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-027

Identifier Type: -

Identifier Source: org_study_id

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