Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Healthy Volunteers (Meningococcal Infection) Clinical Trial

Official title:

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691610
• Other study ID #: MET61
• Secondary ID: U1111-1205-2836M
• Status: Completed
• Phase: Phase 3
• Start date: October 4, 2018
• Est. completion date: October 20, 2023

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: - To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. - To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. - To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. - To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Description:

Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 19 Months

Eligibility

Inclusion criteria :

• Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
• Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
• Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
• For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
• For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

Exclusion criteria:

• Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
• For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
• Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
• Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
• Individuals with active tuberculosis
• History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
• At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
• History of intussusception
• History of any neurologic disorders, including any seizures and progressive neurologic disorders
• History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
• History of Guillain-Barré syndrome
• Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
• Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0 C [= 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Healthy Volunteers (Meningococcal Infection)
• Meningococcal Infections

Intervention

Biological:
• Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
• Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
• Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
• Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
• Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
• Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
• Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
• Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
• Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
• Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
• Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Locations

Country	Name	City	State
Puerto Rico	Investigational Site Number : 6300102	Guayama
Puerto Rico	Investigational Site Number : 6300014	San Juan
United States	MedPharmics Inc Site Number : 8400006	Albuquerque	New Mexico
United States	Emmaus Research Center, Inc Site Number : 8400019	Anaheim	California
United States	ARC Clinical Research at Wilson Parke Site Number : 8400029	Austin	Texas
United States	Victory Clinical Research Site Number : 8400026	Baltimore	Maryland
United States	Meridian Clinical Research, LLC Site Number : 8400035	Baton Rouge	Louisiana
United States	Tekton Research Site Number : 8400047	Beaumont	Texas
United States	Coast Clinical Trials, LLC Site Number : 8400073	Bellflower	California
United States	Alabama Clinical Therapeutics Site Number : 8400036	Birmingham	Alabama
United States	Craig Spiegel, MD Site Number : 8400023	Bridgeton	Missouri
United States	Coastal Pediatric Research Charleston Site Number : 8400002	Charleston	South Carolina
United States	Coastal Pediatric Research Charleston Site Number : 8400011	Charleston	South Carolina
United States	Eagle Clinical Research Site Number : 8400094	Chicago	Illinois
United States	Ohio Pediatric Research Site Number : 8400022	Dayton	Ohio
United States	PriMed Clinical Research Site Number : 8400008	Dayton	Ohio
United States	Mercury Clinical Research, Inc. Site Number : 8400088	Dickinson	Texas
United States	Southeastern Pediatric Associates Site Number : 8400009	Dothan	Alabama
United States	Allegheny Health and Wellness Pavilion Site Number : 8400025	Erie	Pennsylvania
United States	Pediatric Associates of Fall River Site Number : 8400112	Fall River	Massachusetts
United States	Matrix Clinical Research Site Number : 8400082	Gardena	California
United States	Tribe Clinical Research Site Number : 8400118	Greenville	South Carolina
United States	Cyn3rgy Research Site Number : 8400010	Gresham	Oregon
United States	Meridian Clinical Research Site Number : 8400097	Hastings	Nebraska
United States	Kid's Way Pediatrics Site Number : 8400015	Hermitage	Pennsylvania
United States	Next Phase Research Alliance Site Number : 8400044	Homestead	Florida
United States	Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037	Houston	Texas
United States	Snake River Research, PLLC Site Number : 8400058	Idaho Falls	Idaho
United States	PAS Research Site Number : 8400101	Land O' Lakes	Florida
United States	Midwest Childrens Health Research Institute Site Number : 8400111	Lincoln	Nebraska
United States	Midwest Childrens Health Research Institute Site Number : 8400117	Lincoln	Nebraska
United States	All Children Pediatrics Site Number : 8400024	Louisville	Kentucky
United States	Brownsboro Park Pediatrics Site Number : 8400039	Louisville	Kentucky
United States	Axcess Medical Research Site Number : 8400021	Loxahatchee Groves	Florida
United States	Madera Family Med Group Site Number : 8400065	Madera	California
United States	Dr Ruben Aleman & Associates Site Number : 8400062	McAllen	Texas
United States	Velocity Clinical Research Site Number : 8400016	Metairie	Louisiana
United States	Biomedical Research LLC Site Number : 8400041	Miami	Florida
United States	Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046	Miami	Florida
United States	Crystal Biomedical Research Site Number : 8400034	Miami Lakes	Florida
United States	Advantage Clinical Trials Site Number : 8400069	New York	New York
United States	Rio Grade Valley Clinical Research Institute Site Number : 8400084	Pharr	Texas
United States	MedPharmics, LLC - Phoenix Site Number : 8400013	Phoenix	Arizona
United States	Omega Pediatrics Site Number : 8400093	Roswell	Georgia
United States	Tekton Research, Inc. Site Number : 8400040	San Antonio	Texas
United States	Willis-Knighton Physician Network Site Number : 8400075	Shreveport	Louisiana
United States	PAS Research Site Number : 8400059	Tampa	Florida
United States	Pediatric Clinical Trials Tullahoma Site Number : 8400106	Tullahoma	Tennessee
United States	Oklahoma State University - Center for Health Sciences Site Number : 8400110	Tulsa	Oklahoma
United States	Invesclinic.US.LLC Site Number : 8400061	West Palm Beach	Florida
United States	Wilmington Health Site Number : 8400054	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers against meningococcal serogroups A, C, Y, and W	Antibody titers are measured by serum bactericidal assay using human complement (hSBA)	30 days after the second dose of meningococcal vaccine
Secondary	Antibody titers = 1:8 against meningococcal serogroups A, C,Y, and W 30 days after the second dose of meningococcal vaccine	Percentage of participants achieving antibody titers = predefined threshold of 1:8	30 days after the second dose of meningococcal vaccine
Secondary	Percentage of subjects with titer = 4-fold rise from pre-vaccination to post-vaccination 30 days after the second of dose of meningococcal vaccine		30 days after the second dose of meningococcal vaccine
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the first dose of meningococcal vaccine		30 days after the first dose of meningococcal vaccine
Secondary	Percentage of participants with titer = 4-fold rise from pre-vaccination to post-vaccination 30 days after the first dose of meningococcal vaccine		30 days after the first dose of meningococcal vaccine
Secondary	Percentage of participants with hSBA vaccine seroresponse 30 days after the first dose of meningococcal vaccine	The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8	30 days after the first dose of meningococcal vaccine
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W 6 months after the first dose of meningococcal vaccine		6 months after the first dose of meningococcal vaccine
Secondary	Percentage of participants with titer = 4-fold rise from pre-vaccination to post-vaccination 6 months after the first dose of meningococcal vaccine		6 months after the first dose of meningococcal vaccine
Secondary	Percentage of participants with hSBA vaccine seroresponse 6 months after the first dose of meningococcal vaccine	The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8	6 months after the first dose of meningococcal vaccine
Secondary	Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the second dose of meningococcal vaccine		30 days after the second dose of meningococcal vaccine
Secondary	Percentage of participants with titer = 4-fold rise from pre-vaccination to post-vaccination 30 days after the second dose of meningococcal vaccine		30 days after the second dose of meningococcal vaccine
Secondary	Percentage of participants with hSBA vaccine seroresponse 30 days after the second dose of meningococcal vaccine	The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8	30 days after the second 30 days after the second dose of meningococcal vaccine