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

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00432042
First received: February 5, 2007
Last updated: April 3, 2009
Last verified: April 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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:


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: Anne FIQUET, MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00432042     History of Changes
Other Study ID Numbers: X06-MMRV-302
Study First Received: February 5, 2007
Last Updated: April 3, 2009
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)

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Diphtheria
Haemophilus Infections
Hepatitis
Hepatitis A
Hepatitis B
Measles
Mumps
Parotitis
Whooping Cough
Poliomyelitis
Rubella
Tetanus
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on April 22, 2014