Clinical trial

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2)

Name
V114-026
Description
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended schedules by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries. The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen included in Vaxelis™.
Trial arms
Trial start
2019-08-28
Estimated PCD
2021-10-29
Trial end
2021-10-29
Status
Completed
Phase
Early phase I
Treatment
V114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.
Arms:
V114
Other names:
VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine
Prevenar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
Arms:
Prevenar 13™
Other names:
Prevnar 13™
Vaxelis™
Intramuscular 0.5 mL single dose
Arms:
Prevenar 13™, V114
M-M-R®II
Subcutaneous 0.5 mL single dose
Arms:
Prevenar 13™, V114
Other names:
Measles, Mumps, and Rubella Virus Vaccine Live
VARIVAX™
Subcutaneous 0.5 mL single dose
Arms:
Prevenar 13™, V114
Other names:
Varicella Vaccine Live
Size
1191
Primary endpoint
Percentage of Participants With a Solicited Injection-site Adverse Event
Day 1 to Day 14 after each vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
Day 1 to Day 14 after each vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
Up to approximately 6 months after Dose 3 (up to approximately 16 months)
Percentage of Participants Meeting Serotype-specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL 30 Days After Dose 3
30 days after Dose 3
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) 30 Days After Dose 3
30 days after Dose 3
Eligibility criteria
Inclusion Criteria: * Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent. * 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: * Was born prior to 37 weeks of gestation. * Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease. * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid containing vaccine. * Has any contraindication to the concomitant study vaccines being administered in the study. * Has a known or suspected impairment of immunological function. * Has a history of congenital or acquired immunodeficiency. * Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection. * Has, or his/her mother has, a documented hepatitis B surface antigen - positive test. * Has 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 a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders. * Has received a dose of any pneumococcal vaccine prior to study entry. * Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry. * Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry. * Has received a blood transfusion or blood products, including immunoglobulins. * Has 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; these will be reviewed on a case by-case basis for approval by the Sponsor. * Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study. * Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1191, 'type': 'ACTUAL'}}
Updated at
2023-05-06

1 organization

5 products

1 indication

Product
V114
Product
M-M-R®II
Product
VARIVAX™
Product
Vaxelis™