Clinical trial NCT03885934: Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-03-22
Enrollment: 606
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.


Eligibility criteria: Inclusion Criteria

* Not be pregnant or breastfeeding
* Not be a woman of childbearing potential
* If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention
* 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

* History of invasive pneumococcal disease (IPD)
* Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine
* Had a recent febrile illness occurring within 72 hours prior to receipt of study 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
* Has failure to thrive based on the clinical judgement of the investigator
* Has a bleeding 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 known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine
* Meets one or more of the following systemic corticosteroid exclusion criteria: has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing \>10 kg) for ≥14 consecutive days and has not completed this course of treatment at least 30 days prior to the first dose of study vaccine at randomization; has received or is expected to receive systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days prior to any dose of study vaccine; or is expected to require systemic corticosteroids within 30 days after any study vaccination during conduct of the study (Note: Topical, ophthalmic and inhaled steroids are permitted)
* Has received other licensed non-live vaccines within 14 days before receipt of study vaccine. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine
* Has received a licensed live vaccine within 30 days before receipt of study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins, within 6 months before receipt of study vaccine
* Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study

Primary outcomes:
measure: Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months
timeFrame: 30 days post last vaccination
measure: GMC of Serotype-specific IgG - Schedule B: 12-23 Months
timeFrame: 30 days post last vaccination
measure: GMC of Serotype-specific IgG - Schedule C: 2-17 Years
timeFrame: 30 days post vaccination
measure: Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months
timeFrame: Up to 14 days post any vaccination
measure: Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months
timeFrame: Up to 14 days post any vaccination
measure: Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years
timeFrame: Up to 14 days post vaccination
measure: Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months
timeFrame: Up to 14 days post any vaccination
measure: Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months
timeFrame: Up to 14 days post any vaccination
measure: Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years
timeFrame: Up to 14 days post vaccination
measure: Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months
timeFrame: Up to ~6 months post final vaccination
measure: Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months
timeFrame: Up to ~6 months post final vaccination
measure: Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years
timeFrame: Up to ~6 months post vaccination
Secondary outcomes:
measure: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months
timeFrame: 30 days post final vaccination
measure: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months
timeFrame: 30 days post final vaccination
measure: Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years
timeFrame: 30 days post vaccination
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
city: Helsinki
country: Finland
facility: Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
city: Helsinki
country: Finland
facility: Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)
city: Jarvenpaa
country: Finland
facility: Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
city: Kokkola
country: Finland
facility: Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
city: Oulu
country: Finland
facility: Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
city: Pori
country: Finland
facility: Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)
city: Seinajoki
country: Finland
facility: Seinajoki Vaccine Research Center ( Site 0010)
city: Tampere
country: Finland
facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
city: Turku
country: Finland
facility: Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
city: Kota Kinabalu
country: Malaysia
facility: Sabah Womens & Childrens Hospital ( Site 0902)
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 0901)
city: Bydgoszcz
country: Poland
facility: Przychodnia Vitamed Gaaj i Cichomski Spolka Jawna ( Site 0212)
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz ( Site 0210)
city: Lomianki
country: Poland
facility: SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0209)
city: Poznan
country: Poland
facility: Spec Zesp Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu ( Site 0213)
city: Siemianowice Slaskie
country: Poland
facility: NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0211)
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny ( Site 0207)
city: Ekaterinburg
country: Russian Federation
facility: MAI Childrens City Clinical Hospital 11 ( Site 0305)
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of Russian Academy Science ( Site 0317)
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Children Infections ( Site 0301)
city: St.Petersburg
country: Russian Federation
facility: Children s City Polyclinic No. 45 of the Nevsky District ( Site 0312)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 0601)
city: Bangkok
country: Thailand
facility: Vaccine Trial Center Faculty of Tropical Medicine ( Site 0603)
city: Bangkok
country: Thailand
facility: Siriraj Hospital ( Site 0600)
city: Khonkaen
country: Thailand
facility: Srinagarind Hospital ( Site 0602)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Banniettis N, Wysocki J, Szenborn L, Phongsamart W, Pitisuttithum P, Ramet M, Richmond P, Shi Y, Dagan R, Good L, Papa M, Lupinacci R, McFetridge R, Tamms G, Churchill C, Musey L, Bickham K; V114-024 PNEU-PLAN study group. A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants, children, and adolescents (PNEU-PLAN). Vaccine. 2022 Oct 19;40(44):6315-6325. doi: 10.1016/j.vaccine.2022.09.003. Epub 2022 Sep 21.