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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03692871
Registration number
NCT03692871
Ethics application status
Date submitted
28/09/2018
Date registered
2/10/2018
Date last updated
28/07/2023
Titles & IDs
Public title
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU-LINK)
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Secondary ID [1]
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V114-031
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Secondary ID [2]
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V114-031
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections
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Condition category
Condition code
Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - V114
Other interventions - Prevnar 13™
Experimental: 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).
Active Comparator: 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).
Other interventions: V114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Other interventions: Prevnar 13™
Prevnar 13™ 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With a Solicited Injection-site Adverse Event
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Day 14 after each study vaccination
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Primary outcome [2]
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Percentage of Participants With a Solicited Systemic Adverse Event
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Assessment method [2]
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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).
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Timepoint [2]
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Up to Day 14 after each study vaccination
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Primary outcome [3]
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Percentage of Participants With a Vaccine-related Serious Adverse Event
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
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Secondary outcome [1]
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Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
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Assessment method [1]
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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.
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Timepoint [1]
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30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
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Secondary outcome [2]
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GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
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Assessment method [2]
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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.
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Timepoint [2]
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Before Vaccination 4 (10-13 months after Vaccination 1)
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Secondary outcome [3]
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GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
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Assessment method [3]
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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.
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Timepoint [3]
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30 days after Vaccination 4 (11-14 months after Vaccination 1)
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Secondary outcome [4]
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Percentage of Participants Meeting Serotype-specific IgG Threshold of =0.35 µg/mL 30 Days After Vaccination 3 (Premature Infants Only)
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Assessment method [4]
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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.
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Timepoint [4]
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30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
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Eligibility
Key inclusion criteria
- 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.
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Minimum age
42
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Maximum age
90
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/03/2021
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Sample size
Target
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Accrual to date
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Final
2409
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Children s Hospital ( Site 0093) - Clayton
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Recruitment hospital [2]
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Perth Children s Hospital ( Site 0092) - Nedlands
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Recruitment hospital [3]
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Children, Youth and Woman's Health Service ( Site 0094) - North Adelaide
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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5087 - North Adelaide
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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Kansas
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Kentucky
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Louisiana
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New York
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Ohio
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Pennsylvania
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South Carolina
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Texas
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British Columbia
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Canada
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Nova Scotia
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Espoo
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Helsinki
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Oulu
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Pori
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Finland
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Tampere
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Turku
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Germany
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Aschaffenburg
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Germany
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Bramsche
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Germany
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Germany
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Beer-Sheva
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Haifa
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Israel
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Hura
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Israel
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Rahat
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Kuala Lumpur
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Malaysia
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Pelabuhan Klang
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Peru
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Lima
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Peru
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Trujillo
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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™.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03692871
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03692871
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