Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00422292
Other study ID # MTA37
Secondary ID
Status Completed
Phase Phase 3
First received January 12, 2007
Last updated April 12, 2016
Start date December 2006
Est. completion date April 2009

Study information

Verified date April 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

- To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.

- To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination[s]) in subjects in the study groups.

Immunogenicity:

- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.


Description:

No meningococcal vaccine is presently licensed for the population aged < 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged < 2 years would address this important, currently unmet public health need.

At enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.

Twelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group


Recruitment information / eligibility

Status Completed
Enrollment 1664
Est. completion date April 2009
Est. primary completion date January 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Months to 12 Months
Eligibility Inclusion Criteria :

- Healthy, as determined by medical history and physical examination

- Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment

- The parent or legal guardian has signed and dated the Institutional Review Board (IRB)-approved informed consent form.

Exclusion Criteria :

- Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion

- Known or suspected impairment of immunologic function

- Acute medical illness within the last 72 hours or a temperature = 100.4ºF (=38.0ºC) at the time of enrollment.

- History of documented invasive meningococcal disease or previous meningococcal vaccination.

- Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian

- Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids, or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.

- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any blood draw. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

- Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.

- Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.

- Parent or legal guardian unable or unwilling to comply with the study procedures

- Participation in another interventional clinical trial in the 30 days preceding enrollment or planned participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.

- Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine

- Received any vaccine in the 30-day period prior to receipt of the study vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their fourth dose of Pneumococcal conjugate vaccine (PCV) or Haemophilus influenzae type b (Hib) vaccine or their first dose of Measles, mumps, rubella, varicella (MMRV) vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits.

- Personal or family history of Guillain-Barré Syndrome (GBS)

- History of seizures, including febrile seizures, or any other neurologic disorder

- Known hypersensitivity to dry natural rubber latex.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Intervention

Biological:
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, intramuscular (IM)
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL dose, IM
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine
0.5 Ml dose, IM
Measles, Mumps, Rubella and Varicella
0.5 mL dose, SC

Locations

Country Name City State
n/a

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
Other Percentage of Participants With Anti-Pneumococcal Concentrations = 0.35 µg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4 Day 30 after 12-month vaccination No
Other Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.
Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.
Days 0 to 7 after vaccination Yes
Other Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age Days 0 to 7 after vaccination Yes
Primary Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only) Percentage of participants who had a concentration of = 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or = 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; = 500 U/mL (ELISA) or = 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; = 10 IU/mL (ELISA) - for Rubella; and = 300 mIU/mL (ELISA) or = 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella. Day 30 after the 12-month vaccination No
Primary Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4 Day 30 after the 12-month vaccination No
See also
  Status Clinical Trial Phase
Completed NCT04183114 - Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study) Phase 2/Phase 3
Completed NCT00092430 - Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016) Phase 3
Completed NCT02196285 - Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella Phase 1
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT00402831 - ProQuad® Intramuscular vs Subcutaneous Phase 3
Completed NCT00560755 - Safety Study of ProQuad® rHA in Infants (V221-037) Phase 3
Completed NCT01878435 - Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya N/A
Completed NCT01777529 - Comparative Study of the Immunogenicity of MMR (Measles, Mumps and Rubella) Single Dose and Multidose Presentations Phase 4
Terminated NCT00258726 - Immune Responses to Two Dose Varivax +/- MMR-II Phase 1/Phase 2
Completed NCT00109278 - A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED) Phase 2
Not yet recruiting NCT05771779 - Co-administration Study of OCV, TCV and MR Phase 3
Completed NCT02880865 - Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine Phase 4
Completed NCT01681992 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life Phase 3
Completed NCT00751348 - Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 Phase 3
Completed NCT01702428 - Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age Phase 3
Completed NCT00969436 - Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM Phase 3
Completed NCT00566527 - Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) Phase 3
Completed NCT00127010 - Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases Phase 3
Completed NCT00388440 - Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore. Phase 4

External Links