A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
NCT ID: NCT01049035
Last Updated: 2022-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
580 participants
INTERVENTIONAL
2009-12-16
2012-02-13
Brief Summary
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Objectives:
* To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
* To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
* To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months
Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months
Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 5: MenACYW Conjugate Vaccine: Month 12
Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 6: Control: 2, 4, 6, and 12 Months
Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Group 7: Control: 2, 4, 6, 12, and 15 Months
Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Interventions
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Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection
Varicella Virus Vaccine Live
0.5 mL, SC injection
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Rotavirus Vaccine
oral
Hepatitis B Vaccine
0.5 mL, IM injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born at full term of pregnancy (greater than or equal to \[≥\] 37 weeks) and with a birth weight ≥2.5 kilogram (kg).
* Informed consent form had been signed and dated by the parent or other legally acceptable representative.
* Participant and parent/guardian were able to attend all scheduled visits and to be complied with all trial procedures.
* Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses of rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine.
Group 5 only: Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of rotavirus vaccine; and 3 previous doses of hepatitis B vaccine.
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with the exception of influenza vaccine, which may be received 14 days before or after MenACYW Conjugate vaccine.
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
* Receipt of blood or blood-derived products in the past 30 days, which might interfere with assessment of the immune response.
* 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).
* Known personal or maternal seropositivity for human immunodeficiency virus (HIV), hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian.
* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
* At high risk for meningococcal infection during the trial.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
* Thrombocytopenia, as reported by the parent/guardian.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* History of seizures.
* Personal or family history of Guillain-Barré Syndrome (GBS).
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
Temporary contraindications were resolved before vaccination:
* Febrile illness (temperature ≥38.0 degree Celsius \[≥100.4 degree Fahrenheit\]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.
* Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops were not included in this exclusion criterion. (Note: This did not applied to the other groups at this time, as they did not have a blood draw within 30 days of the initial visit.).
42 Days
365 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Birmingham, Alabama, United States
Tuscaloosa, Alabama, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Huntington Beach, California, United States
Marietta, Georgia, United States
Woodstock, Georgia, United States
Bardstown, Kentucky, United States
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Bossier City, Louisiana, United States
Clyde, North Carolina, United States
Cleveland, Ohio, United States
Pittsburgh, Pennsylvania, United States
Barnwell, South Carolina, United States
Clarksville, Tennessee, United States
Fort Worth, Texas, United States
Layton, Utah, United States
Orem, Utah, United States
Springville, Utah, United States
Midlothian, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Countries
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References
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Cornish MJ, Hedrick JA, Gabrielsen AA, Johnson AD, Miriam Pina L, Rehm C, Pan J, Neveu D, Da Costa X, Jordanov E, Dhingra MS. Safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in infants and toddlers: A Phase II study. Vaccine. 2022 Mar 1;40(10):1421-1438. doi: 10.1016/j.vaccine.2022.01.050. Epub 2022 Feb 7.
Other Identifiers
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UTN: U1111-1112-2593
Identifier Type: OTHER
Identifier Source: secondary_id
MET39
Identifier Type: -
Identifier Source: org_study_id
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