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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
Secondary ID [1] 0 0
V114-031
Secondary ID [2] 0 0
V114-031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - V114
Treatment: Other - 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).


Treatment: Other: 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

Treatment: Other: 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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Solicited Injection-site Adverse Event
Timepoint [1] 0 0
Up to Day 14 after each study vaccination
Primary outcome [2] 0 0
Percentage of Participants With a Solicited Systemic Adverse Event
Timepoint [2] 0 0
Up to Day 14 after each study vaccination
Primary outcome [3] 0 0
Percentage of Participants With a Vaccine-related Serious Adverse Event
Timepoint [3] 0 0
Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Secondary outcome [1] 0 0
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
Timepoint [1] 0 0
30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
Secondary outcome [2] 0 0
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
Timepoint [2] 0 0
Before Vaccination 4 (10-13 months after Vaccination 1)
Secondary outcome [3] 0 0
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
Timepoint [3] 0 0
30 days after Vaccination 4 (11-14 months after Vaccination 1)
Secondary outcome [4] 0 0
Percentage of Participants Meeting Serotype-specific IgG Threshold of =0.35 µg/mL 30 Days After Vaccination 3 (Premature Infants Only)
Timepoint [4] 0 0
30 days after Vaccination 3 (approximately 5 months after Vaccination 1)

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.
Minimum age
42 Days
Maximum age
90 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/03/2021
Sample size
Target
Accrual to date
Final
2409
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children s Hospital ( Site 0093) - Clayton
Recruitment hospital [2] 0 0
Perth Children s Hospital ( Site 0092) - Nedlands
Recruitment hospital [3] 0 0
Children, Youth and Woman's Health Service ( Site 0094) - North Adelaide
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
5087 - North Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Finland
State/province [18] 0 0
Espoo
Country [19] 0 0
Finland
State/province [19] 0 0
Helsinki
Country [20] 0 0
Finland
State/province [20] 0 0
Jarvenpaa
Country [21] 0 0
Finland
State/province [21] 0 0
Kokkola
Country [22] 0 0
Finland
State/province [22] 0 0
Oulu
Country [23] 0 0
Finland
State/province [23] 0 0
Pori
Country [24] 0 0
Finland
State/province [24] 0 0
Seinajoki
Country [25] 0 0
Finland
State/province [25] 0 0
Tampere
Country [26] 0 0
Finland
State/province [26] 0 0
Turku
Country [27] 0 0
Germany
State/province [27] 0 0
Aschaffenburg
Country [28] 0 0
Germany
State/province [28] 0 0
Bramsche
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Huerth
Country [31] 0 0
Germany
State/province [31] 0 0
Lauffen
Country [32] 0 0
Germany
State/province [32] 0 0
Moenchengladbach
Country [33] 0 0
Germany
State/province [33] 0 0
Munchengladbach
Country [34] 0 0
Germany
State/province [34] 0 0
Schoenau
Country [35] 0 0
Germany
State/province [35] 0 0
Wolfsburg
Country [36] 0 0
Israel
State/province [36] 0 0
Beer Sheva
Country [37] 0 0
Israel
State/province [37] 0 0
Beer-Sheva
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Hura
Country [40] 0 0
Israel
State/province [40] 0 0
Rahat
Country [41] 0 0
Malaysia
State/province [41] 0 0
Perak
Country [42] 0 0
Malaysia
State/province [42] 0 0
Sarawak
Country [43] 0 0
Malaysia
State/province [43] 0 0
Kuala Lumpur
Country [44] 0 0
Malaysia
State/province [44] 0 0
Pelabuhan Klang
Country [45] 0 0
Peru
State/province [45] 0 0
Lima
Country [46] 0 0
Peru
State/province [46] 0 0
Trujillo
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taichung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taoyuan
Country [50] 0 0
Thailand
State/province [50] 0 0
Bangkok
Country [51] 0 0
Thailand
State/province [51] 0 0
Chiang Mai
Country [52] 0 0
Thailand
State/province [52] 0 0
Hat Yai
Country [53] 0 0
Thailand
State/province [53] 0 0
Khon Kaen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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™.
Trial website
https://clinicaltrials.gov/study/NCT03692871
Trial related presentations / publications
Banniettis N, Horn M, Sadarangani M, Patel SM, Greenberg D, Oberdorfer P, Klein NP, Rupp R, Dagan R, Richmond P, Lumley J, Zhou W, Shi Y, Tamms G, Feemster K, Lupinacci R, Musey L, Bickham K; V114-031 (PNEU-LINK) study group. Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study. Pediatrics. 2023 Jul 1;152(1):e2022060428. doi: 10.1542/peds.2022-060428.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03692871