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Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (MET41)

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: NCT03673462
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:
The primary objective of this study is 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 (MENVEO®) Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine Biological: Pneumococcal 13-valent Conjugate Vaccine Biological: Rotavirus Vaccine Biological: Hepatitis B Vaccine Biological: Measles, Mumps, and Rubella Virus Vaccine Biological: Varicella Virus Vaccine Phase 3

Detailed Description:
Study duration per participant is approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A modified double blind design is used. With the exception of the personnel administering the vaccine, everyone involved in study (participants, care provider, investigator, safety outcomes assessor, Sponsor) is blinded.
Primary Purpose: Prevention
Official Title: A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MenACYW conjugate vaccine
MenACYW conjugate vaccine, 4 doses at 2, 4, 6, and 12 months of age, co-administered with routine vaccines
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine)
Pharmaceutical form: liquid solution. Route of administration: Intramuscular

Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Pharmaceutical form:Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

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

Biological: Rotavirus Vaccine
Pharmaceutical form:Oral solution Route of administration: Oral

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

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

Biological: Varicella Virus Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous

Active Comparator: MENVEO®
MENVEO®, 4 doses at 2, 4, 6, and 12 months of age, co-administered with routine vaccines
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)
Pharmaceutical form:Lyophilized powder combined with liquid components Route of administration: Intramuscular

Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Pharmaceutical form:Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

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

Biological: Rotavirus Vaccine
Pharmaceutical form:Oral solution Route of administration: Oral

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

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

Biological: Varicella Virus Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous




Primary Outcome Measures :
  1. Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after any injection ]
    Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability

  2. Participant with immediate adverse events [ Time Frame: Within 30 minutes after any injection ]
    Immediate adverse events are unsolicited systemic adverse events occuring in the 30 minutes after injection

  3. Participant with unsolicited adverse events [ Time Frame: Within 30 days after any injection ]
    Unsolicited adverse events are adverse events other than solicited reactions

  4. Participant with serious adverse events [ Time Frame: From Day 0 to Month 6 ]
    Serious adverse events are collected throughout the study

  5. Participant with medically attended adverse events [ Time Frame: From Day 0 to Month 6 ]
    Medically attended adverse events are collected throughout the study



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.


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Ages Eligible for Study:   42 Days to 89 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
  • Healthy infants as determined by medical history, physical examination, and judgment of the investigator.
  • Informed consent form has been signed and dated by the parent(s) or 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.
  • Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit

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, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease.
  • Receipt of more than 1 previous dose of hepatitis B vaccine.
  • Receipt of immune globulins, blood or blood-derived products since birth.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
  • 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, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection/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 traveling to countries with high endemic or epidemic disease).
  • History of intussusception.
  • History of any neurologic disorders, including seizures and progressive neurologic disorders.
  • 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.
  • Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) 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 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): NCT03673462


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

Locations
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03673462    
Other Study ID Numbers: MET41
U1111-1183-6261 ( Other Identifier: WHO )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 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/

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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:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs