A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: Prevnar 13™Biological: V114
- Registration Number
- NCT03692871
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2409
- Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
- Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
- Have 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.
- History of Invasive Pneumococcal Disease (IPD) (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) or any diphtheria toxoid containing vaccine
- 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
- 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 a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
- Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
- 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 who is investigational site or Sponsor staff directly involved with this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prevnar 13™ Prevnar 13™ Participants will receive a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). V114 V114 Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4).
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Solicited Injection-site Adverse Event Up to Day 14 after each study vaccination An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Percentage of Participants With a Vaccine-related Serious Adverse Event Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) A serious adverse event (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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Percentage of Participants With a Solicited Systemic Adverse Event Up to Day 14 after each study vaccination An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
- Secondary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) Before Vaccination 4 (10-13 months after Vaccination 1) The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) 30 days after Vaccination 4 (11-14 months after Vaccination 1) The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Trial Locations
- Locations (76)
Tampereen yliopisto Etela-Helsingin Rokotetutkimusklinikka ( Site 0064)
🇫🇮Helsinki, Finland
Seinajoki Vaccine Research Center ( Site 0070)
🇫🇮Seinajoki, Finland
Chulalongkorn University ( Site 0102)
🇹🇭Bangkok, Thailand
National Taiwan University Hospital ( Site 0097)
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0098)
🇨🇳Taoyuan, Taiwan
Pediatric Associates [Houston, TX] ( Site 0039)
🇺🇸Houston, Texas, United States
Kinderarztpraxis ( Site 0081)
🇩🇪Huerth, Germany
Beach Pediatrics ( Site 0040)
🇺🇸Huntington Beach, California, United States
Kaiser Permanente - Santa Clara ( Site 0027)
🇺🇸Santa Clara, California, United States
Premier Health Research Center, LLC ( Site 0005)
🇺🇸Downey, California, United States
Kaiser Permanente - San Jose ( Site 0036)
🇺🇸San Jose, California, United States
Medical Research South, LLC ( Site 0013)
🇺🇸Charleston, South Carolina, United States
Perth Children s Hospital ( Site 0092)
🇦🇺Nedlands, Australia
Pediatric Partners, P.A. ( Site 0010)
🇺🇸Overland Park, Kansas, United States
Advanced Research For Health Improvement LLC ( Site 0030)
🇺🇸Naples, Florida, United States
Novak Center for Childrens Health ( Site 0033)
🇺🇸Louisville, Kentucky, United States
Medpharmics, LLC ( Site 0037)
🇺🇸Metairie, Louisiana, United States
Child Health Care Associates ( Site 0024)
🇺🇸East Syracuse, New York, United States
Children, Youth and Woman's Health Service ( Site 0094)
🇦🇺North Adelaide, Australia
McGill University Health Centre - Vaccine Study Centre ( Site 0045)
🇨🇦Pierrefonds, Quebec, Canada
CHUQ - Unite de Recherche en Sante Publique ( Site 0042)
🇨🇦Quebec, Canada
University of Texas Medical Branch ( Site 0018)
🇺🇸League City, Texas, United States
University of Wisconsin American Family Children's Hospital ( Site 0023)
🇺🇸Madison, Wisconsin, United States
Vaccine Evaluation Center BC Children s Hospital Research Institute ( Site 0046)
🇨🇦Vancouver, British Columbia, Canada
Porin Rokotetutkimusklinikka ( Site 0069)
🇫🇮Pori, Finland
Kinderarztpraxis ( Site 0124)
🇩🇪Aschaffenburg, Germany
Kinderarztpraxis Dr. Friedrich Kaiser & Dr. Marinesse ( Site 0085)
🇩🇪Hamburg, Germany
Kinderarztpraxis ( Site 0123)
🇩🇪Bramsche, Germany
Kinderarztpraxis Dr. Muehlschlegel - Dr. Goetz ( Site 0122)
🇩🇪Lauffen, Germany
Kinderarztpraxis ( Site 0080)
🇩🇪Moenchengladbach, Germany
Kinderarztpraxis ( Site 0084)
🇩🇪Schoenau, Germany
Soroka University Medical Center - Ramot Family health center ( Site 0078)
🇮🇱Beer-Sheva, Israel
Rambam Medical Center- Keriat Eliezer Family Health Center ( Site 0138)
🇮🇱Haifa, Israel
Klinik Kesihatan Greentown ( Site 0132)
🇲🇾Ipoh, Perak, Malaysia
Klinik Kesihatan Pandamaran ( Site 0110)
🇲🇾Pelabuhan Klang, Malaysia
Clinica Peruano Americana S.A. ( Site 0061)
🇵🇪Trujillo, Peru
Hamilton Medical Research Group ( Site 0049)
🇨🇦Hamilton, Ontario, Canada
Kinderarztpraxis Matthias Donner Dr. M. Luechtrath ( Site 0091)
🇩🇪Munchengladbach, Germany
Tanner Clinic ( Site 0009)
🇺🇸Layton, Utah, United States
Primedical Clinical Research ( Site 0035)
🇺🇸Dayton, Ohio, United States
Khruz Biotechnology Research Institute ( Site 0006)
🇺🇸San Diego, California, United States
Children's Research, LLC ( Site 0025)
🇺🇸Lake Mary, Florida, United States
Wee Care Pediatrics ( Site 0020)
🇺🇸Roy, Utah, United States
Thomas Jefferson University ( Site 0029)
🇺🇸Philadelphia, Pennsylvania, United States
CCP- Kid's Way ( Site 0008)
🇺🇸Hermitage, Pennsylvania, United States
Jarvenpaan rokotetutkimuskeskus ( Site 0067)
🇫🇮Jarvenpaa, Finland
Kokkolan rokotetutkimusklinikka ( Site 0071)
🇫🇮Kokkola, Finland
CHU Sainte Justine ( Site 0047)
🇨🇦Montreal, Quebec, Canada
Medicor Research Inc. ( Site 0041)
🇨🇦Sudbury, Ontario, Canada
Ita-Helsingin Rokotetutkimuskeskus ( Site 0065)
🇫🇮Helsinki, Finland
Turun rokotetutkimuskeskus ( Site 0068)
🇫🇮Turku, Finland
Soroka University Medical Center ( Site 0077)
🇮🇱Beer Sheva, Israel
Sarawak General Hospital ( Site 0107)
🇲🇾Kuching, Sarawak, Malaysia
Rambam Medical Center ( Site 0076)
🇮🇱Haifa, Israel
Kinderaerztliche Gemeinschaftspraxis Drs. Westerholt/Matyas ( Site 0083)
🇩🇪Wolfsburg, Germany
Universiti Malaya Medical Center-Clinical Investigation Center ( Site 0108)
🇲🇾Kuala Lumpur, Malaysia
Instituto de Investigacion Nutricional ( Site 0058)
🇵🇪Lima, Peru
Taichung Veterans General Hospital ( Site 0100)
🇨🇳Taichung, Taiwan
Srinagarind Hospital. Khon Kaen University ( Site 0104)
🇹🇭Khon Kaen, Thailand
Prince of Songkla University, Faculty of Medicine ( Site 0105)
🇹🇭Hat Yai, Thailand
Espoon rokotetutkimuskeskus ( Site 0066)
🇫🇮Espoo, Finland
IWK Health Centre [Halifax, Canada] ( Site 0043)
🇨🇦Halifax, Nova Scotia, Canada
Monash Children s Hospital ( Site 0093)
🇦🇺Clayton, Victoria, Australia
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0072)
🇫🇮Oulu, Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0063)
🇫🇮Tampere, Finland
Hospital Nacional Docente Madre - Nino San Bartolome ( Site 0057)
🇵🇪Lima, Peru
Rambam Medical Center- Neve David Family Health Center ( Site 0139)
🇮🇱Haifa, Israel
Soroka Medical Center_ Hura Family health center ( Site 0137)
🇮🇱Hura, Israel
Soroka University Medical Center - Rahat Family health center ( Site 0079)
🇮🇱Rahat, Israel
Siriraj Hospital ( Site 0101)
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 0103)
🇹🇭Chiang Mai, Thailand
Allegheny Health & Wellness Pavilion West ( Site 0034)
🇺🇸Erie, Pennsylvania, United States
Wee Care Pediatrics ( Site 0031)
🇺🇸Layton, Utah, United States
Alberta Children s Hospital ( Site 0048)
🇨🇦Calgary, Alberta, Canada
Hospital Sibu ( Site 0111)
🇲🇾Sibu, Sarawak, Malaysia
Mackay Memorial Hospital ( Site 0099)
🇨🇳Taipei, Taiwan