Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (V114-024) (PNEU-PLAN)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03885934 |
Recruitment Status :
Completed
First Posted : March 22, 2019
Last Update Posted : December 14, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumococcal Infections | Biological: V114 Biological: Prevnar 13 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 606 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
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) |
Actual Study Start Date : | June 25, 2019 |
Actual Primary Completion Date : | December 9, 2020 |
Actual Study Completion Date : | December 9, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: V114
Each dose consists of 0.5 mL Intramuscular (IM) injection. Schedule A, 7 to 11 months of age, 3 doses: Dose 1 at randomization, Dose 2 at 1-2 months after Dose 1, and Dose 3 at 2-3 months after Dose 2 and at ≥12 months of age. Schedule B, 12 to 23 months of age, 2 doses: Dose 1 at randomization, and Dose 2 at 2-3 months after Dose 1. Schedule C, 2 to 17 years of age, 1 dose: Single dose at randomization.
|
Biological: V114
V114 15-valent PVC 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 |
Active Comparator: Prevnar 13
Each dose consists of 0.5 mL IM injection. Schedule A, 7 to 11 months of age, 3 doses: Dose 1 at randomization, Dose 2 at 1-2 months after Dose 1, and Dose 3 at 2-3 months after Dose 2 and at ≥12 months of age. Schedule B, 12 to 23 months of age, 2 doses: Dose 1 at randomization, and Dose 2 at 2-3 months after Dose 1. Schedule C, 2 to 17 years of age, 1 dose: Single dose at randomization.
|
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. |
- Immunoglobulin G (IgG) GMCs for Each of the 15 Serotypes [ Time Frame: 30 days post final vaccination ]Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL).
- Percentage of Participants that Report at Least 1 Solicited Injection-site Adverse Event (AE) [ Time Frame: Up to 14 days post any vaccination ]An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant are to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occur in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) will be summarized.
- Percentage of Participants that Report at Least 1 Solicited Systemic AE [ Time Frame: Up to 14 days post any vaccination ]An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The parent/guardian of the participant are to record the presence of any VRC-prompted systemic AEs that occur in the 14 days after any vaccination. The percentage of participants with a systemic AE will be summarized.
- Percentage of Participants that Report at Least 1 Vaccine-related AE [ Time Frame: 30 days post final vaccination ]An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. The percentage of participants that report at least 1 AE that was considered at least possibly related to the study vaccine will be summarized.
- Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes [ Time Frame: 30 days post final vaccination ]Sera from participants will be used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL. The percentage that achieve the GMC threshold value of ≥0.35 μg/mL will be summarized.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Months to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
- Healthy
- 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 pneumococcal conjugate vaccine (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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885934

Study Director: | Study Director | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT03885934 |
Other Study ID Numbers: |
V114-024 V114-024 ( Other Identifier: Merck ) 2018-003706-88 ( EudraCT Number ) |
First Posted: | March 22, 2019 Key Record Dates |
Last Update Posted: | December 14, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |