February 5, 2007 |
April 3, 2009 |
January 2007 |
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Complete list of historical versions of study NCT00432042 on ClinicalTrials.gov Archive Site |
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Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly |
An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of Concomitant Versus Separate Administration of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) and a Booster Dose of Infanrix® Hexa in Healthy Children 12 to 23 Months of Age |
Primary Objective:
- To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.
Secondary Objectives:
- To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.
- To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.
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Phase III |
Interventional |
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Varicella
- Measles
- Mumps
- Rubella
- Diphtheria
- Tetanus
- Pertussis
- Poliomyelitis
- Hepatitis B
- Haemophilus Infections
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Biological: ProQuad® and Infanrix® hexa |
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Completed |
960 |
March 2008 |
March 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Healthy subjects of either gender
- Aged 12 to 23 months
- No clinical history of measles, mumps, rubella, varicella and zoster
- For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
- For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
- Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
- Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.
Exclusion Criteria:
- Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
- Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
- Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
- Any recent (<= 3 days) history of febrile illness
- Any severe chronic disease
- Active untreated tuberculosis
- Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
- Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
- Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
- Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
- Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
- Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
- Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
- Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
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Both |
12 Months to 23 Months |
Yes |
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Germany, Italy |
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NCT00432042 |
Anne FIQUET, MD, Sanofi Pasteur MSD |
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Sanofi Pasteur MSD |
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Study Director: |
Anne Fiquet, MD |
SPMSD |
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Sanofi Pasteur MSD |
April 2009 |