Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly - Full Text View

Sponsored by:	Sanofi Pasteur MSD
Information provided by:	Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:	NCT00432042

Purpose

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.

Condition	Intervention	Phase
Varicella Measles Mumps Rubella Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B Haemophilus Infections	Biological: ProQuad® and Infanrix® hexa	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Chickenpox Diphtheria Flu Hepatitis Hepatitis B Measles Mumps Polio and Post-Polio Syndrome Rubella Shingles Tetanus Whooping Cough

Drug Information available for: Infanrix hexa

U.S. FDA Resources

Further study details as provided by Sanofi Pasteur MSD:

Estimated Enrollment:	960
Study Start Date:	January 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	12 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432042

Show 50 Study Locations

Sponsors and Collaborators

Sanofi Pasteur MSD

Investigators

Study Director:

Anne Fiquet, MD

SPMSD

More Information

No publications provided

Responsible Party:	Sanofi Pasteur MSD ( Anne FIQUET, MD )
Study ID Numbers:	X06-MMRV-302
Study First Received:	February 5, 2007
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00432042 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut; Italy: The Italian Medicines Agency

Keywords provided by Sanofi Pasteur MSD:

Mumps and Rubella
Haemophilus influenzae type b (Infanrix® hexa)

Study placed in the following topic categories:

Mouth Diseases
Haemophilus Infections
Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Measles
Whooping Cough
Hepatitis, Viral, Human
Healthy
Tetanus
Rubella
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Hepatitis B
Degenerative Motor System Disease
Motor Neuron Disease
Salivary Gland Diseases
Herpes Zoster
Paramyxoviridae Infections
Haemophilus Influenzae
Central Nervous System Diseases
Picornaviridae Infections
Chickenpox
Cough
Diphtheria
Togaviridae Infections
Herpesviridae Infections

Additional relevant MeSH terms:

Bacterial Infections
Mouth Diseases
Liver Diseases
Morbillivirus Infections
Whooping Cough
Central Nervous System Viral Diseases
Rubella
Hepadnaviridae Infections
Neuromuscular Diseases
Hepatitis B
Salivary Gland Diseases
Nervous System Diseases
Chickenpox
Picornaviridae Infections
Herpesviridae Infections

Virus Diseases
Hepatitis
DNA Virus Infections
Enterovirus Infections
Mumps
Parotitis
Haemophilus Infections
Spinal Cord Diseases
Measles
Hepatitis, Viral, Human
Infection
Gram-Negative Bacterial Infections
Rubivirus Infections
Gram-Positive Bacterial Infections
Parotid Diseases

ClinicalTrials.gov processed this record on September 02, 2009