Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)

NCT ID: NCT03885934

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2020-12-09

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.

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V114, Schedule A: Participants 7-11 months

Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine \[PCV\]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

Prevnar 13®, Schedule A: Participants 7-11 months

Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age.

Group Type: ACTIVE_COMPARATOR

Prevnar 13®

Intervention Type: BIOLOGICAL

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

V114, Schedule B: Participants 12-23 months

Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

Prevnar 13®, Schedule B: Participants 12-23 months

Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1.

Group Type: ACTIVE_COMPARATOR

Prevnar 13®

Intervention Type: BIOLOGICAL

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

V114, Schedule C: Participants 2-17 years

Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

Group Type: EXPERIMENTAL

V114

Intervention Type: BIOLOGICAL

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

Prevnar 13®, Schedule C: Participants 2-17 years

Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced.

Group Type: ACTIVE_COMPARATOR

Prevnar 13®

Intervention Type: BIOLOGICAL

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Interventions

V114

V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration

Intervention Type: BIOLOGICAL

Prevnar 13®

Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™; PCV13

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
• 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

• Minimum Eligible Age: 7 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

Espoo, , Finland

Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)

Helsinki, , Finland

Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006)

Helsinki, , Finland

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

Järvenpää, , Finland

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)

Kokkola, , Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

Oulu, , Finland

Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008)

Pori, , Finland

Seinajoki Vaccine Research Center ( Site 0010)

Seinäjoki, , Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

Tampere, , Finland

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Turku, , Finland

Sabah Womens & Childrens Hospital ( Site 0902)

Kota Kinabalu, , Malaysia

University Malaya Medical Centre ( Site 0901)

Kuala Lumpur, , Malaysia

Przychodnia Vitamed Gaaj i Cichomski Spolka Jawna ( Site 0212)

Bydgoszcz, , Poland

Centrum Medyczne Pratia Bydgoszcz ( Site 0210)

Bydgoszcz, , Poland

Spec Zesp Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu ( Site 0213)

Poznan, , Poland

NZ Lecznictwa Ambulatoryjnego - Michalkowice - Jarosz i Partnerzy ( Site 0211)

Siemianowice Śląskie, , Poland

Uniwersytecki Szpital Kliniczny ( Site 0207)

Wroclaw, , Poland

SPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0209)

Łomianki, , Poland

Central Clinical Hospital of Russian Academy Science ( Site 0317)

Moscow, , Russia

Children s City Polyclinic No. 45 of the Nevsky District ( Site 0312)

Saint Petersburg, , Russia

Research Institute of Children Infections ( Site 0301)

Saint Petersburg, , Russia

MAI Childrens City Clinical Hospital 11 ( Site 0305)

Yekaterinburg, , Russia

Chulalongkorn University ( Site 0601)

Bangkok, , Thailand

Vaccine Trial Center Faculty of Tropical Medicine ( Site 0603)

Bangkok, , Thailand

Siriraj Hospital ( Site 0600)

Bangkok, , Thailand

Srinagarind Hospital ( Site 0602)

Khonkaen, , Thailand

Countries

Finland; Malaysia; Poland; Russia; Thailand

References

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.

Reference Type: RESULT

PMID: 36150974 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-003706-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V114-024

Identifier Type: -

Identifier Source: org_study_id