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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 5, 2007

Last Updated Date

April 3, 2009

Start Date ^†

January 2007

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00432042 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Varicella
Measles
Mumps
Rubella
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Infections

Intervention ^†

Biological: ProQuad® and Infanrix® hexa

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

960

Completion Date

March 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

12 Months to 23 Months

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Germany, Italy

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00432042

Responsible Party

Anne FIQUET, MD, Sanofi Pasteur MSD

Secondary IDs ^††

Study Sponsor ^†

Sanofi Pasteur MSD

Collaborators ^††

Investigators ^†

Study Director:

Anne Fiquet, MD

SPMSD

Information Provided By

Sanofi Pasteur MSD

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.