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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Haemophilus Infections
Hepatitis B
Herpes Zoster
Measles
Poliomyelitis
Rubella
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Gram-Negative Bacterial Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Herpesviridae Infections
Liver Diseases
Mononegavirales Infections
Morbillivirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Paramyxoviridae Infections
Pasteurellaceae Infections
Picornaviridae Infections
RNA Virus Infections
Rubivirus Infections

ClinicalTrials.gov processed this record on October 21, 2014