Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691610
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief 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 objective is to demonstrate the non-inferiority of the percentage of subjects 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.

The study also includes as an observational objective to describe the safety profile of MenACYW conjugate vaccine and MENVEO® when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.


Condition or disease Intervention/treatment Phase
Healthy Volunteers (Meningococcal Infection) Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Biological: Haemophilus b Conjugate Vaccine Biological: Pneumococcal 13-valent Conjugate Vaccine Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Hepatitis B Vaccine Biological: Measles, Mumps, and Rubella Virus Vaccine Live Biological: Varicella Virus Vaccine Live Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias.
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
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

Biological: 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

Biological: 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

Biological: Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

Biological: Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL

Biological: Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL

Biological: Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Active Comparator: Group 2
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Biological: 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

Biological: 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

Biological: 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

Biological: Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

Biological: Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL

Biological: Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL

Biological: Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Experimental: Group 3
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
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

Active Comparator: Group 4
Menactra® at 17 to 19 months of age and 20 to 23 months of age
Biological: 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




Primary Outcome Measures :
  1. Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
    Antibody titers are measured by serum bactericidal assay using human complement (hSBA)


Secondary Outcome Measures :
  1. Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
    % of participants achieving antibody titers ≥ predefined threshold of 1:8

  2. Number of participants reporting solicited injection site reactions or systemic reactions [ Time Frame: Within 7 days after vaccination ]
    Injection site reactions: tenderness, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 19 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Aged 6 to 7 months (164 to 224 days) or 17 to 19 months on the day of the first visit
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • 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 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) or rotavirus vaccine
  • For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 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.


Information from the National Library of Medicine

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): NCT03691610


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
Show Show 31 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company

Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03691610    
Other Study ID Numbers: MET61
U1111-1205-2836 ( Other Identifier: UTN )
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs