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A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine (TetraMen-T) in Infants and Toddlers

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ClinicalTrials.gov Identifier: NCT01049035
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of this study is to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease.

Objectives:

  • To describe the safety profile of TetraMen-T vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
  • To describe the immunogenicity profile of TetraMen-T 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 TetraMen-T vaccine.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Infection Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate Biological: Pentacel® Biological: M-M-R®II Biological: Varivax® Biological: Prevnar® Biological: RotaTeq® Biological: Engerix-B® Phase 2

Detailed Description:
Participants will receive study vaccinations beginning at age 2, 6, or 12 months, depending on the assigned schedule in their randomized groups. All participants will undergo safety and immunogenicity assessments according to the schedule for their assigned group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) Administered in Infants and Toddlers
Study Start Date : December 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TetraMen-T Group 1
Participants will receive TetraMen-T vaccine at 2, 4, 6, and 12 Months
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Experimental: TetraMen-T Group 2
Participants will receive TetraMen-T vaccine at 2, 4, 6, and 15 Months.
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Experimental: TetraMen-T Group 3
Participants will receive TetraMen-T vaccine at 2, 4, and 12 Months
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Experimental: TetraMen-T Group 4
Participants will receive TetraMen-T vaccine at 6 and 12 Months
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Experimental: TetraMen-T Group 5
Participants will receive TetraMen-T vaccine at 12 Months
Biological: Meningococcal Polysaccharide Tetanus Protein Conjugate
0.5 mL, Intramuscular

Study Group 6
Participants will not receive TetraMen-T vaccine; Only routine vaccines at 2, 4, 6, and 12 Months
Biological: Pentacel®
As in the prescribing information (All are licensed vaccines)
Other Name: Routine pediatric vaccines

Biological: M-M-R®II
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Varivax®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Prevnar®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: RotaTeq®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Engerix-B®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Study Group 7
Participants will not receive TetraMen-T vaccine; Only routine Vaccines at 2, 4, 6, and 15 Months.
Biological: Pentacel®
As in the prescribing information (All are licensed vaccines)
Other Name: Routine pediatric vaccines

Biological: M-M-R®II
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Varivax®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Prevnar®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: RotaTeq®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine

Biological: Engerix-B®
As in the prescribing information
Other Name: Routine licensed pediatric vaccine




Primary Outcome Measures :
  1. To provide information concerning the immunogenicity of meningococcal tetanus protein conjugate (TetraMen-T) vaccine. [ Time Frame: 30 days post 4- or 6-month vaccination; before and 30 days post-final vaccinations. ]
  2. To provide information concerning the safety after administration of meningococcal tetanus protein conjugate (TetraMen-T) vaccine. [ Time Frame: 0-7 days post-vaccination and entire study duration ]


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 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6 months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days + 14 days) on the day of inclusion
  • 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 or other legally acceptable representative
  • Participant and parent/guardian are able to attend all scheduled visits and to comply 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 :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • 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 TetraMen-T 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, is at a stage where it might interfere with trial conduct or completion

Temporary contraindications to be resolved before vaccination:

  • Febrile illness (temperature ≥38.0°C [≥100.4°F]) 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 are not included in this exclusion criterion. (Note: This does not apply to the other groups at this time, as they will not be having a blood draw within 30 days of the initial visit.)

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): NCT01049035


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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01049035     History of Changes
Other Study ID Numbers: MET39
UTN: U1111-1112-2593 ( Other Identifier: WHO )
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Infection
Neisseria meningitidis
Tetravalent Meningococcal Vaccine
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs