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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432042
First Posted: February 6, 2007
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: None (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 Merck Sharp & Dohme Corp.:

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432042


  Hide Study Locations
Locations
Germany
Alsfeld, Germany
Bad Saulgau, Germany
Bad Sobernheim, Germany
Bad Säckingen, Germany
Berlin, Germany
Bielefeld, Germany
Birkenfeld, Germany
Bramsche, Germany
Bretten, Germany
Brunsbüttel, Germany
Datteln, Germany
Detmold, Germany
Espelkamp, Germany
Ettenheim, Germany
Friedrichshafen, Germany
Gerolstein, Germany
Gifhorn, Germany
Gütersloh, Germany
Hamburg, Germany
Heilbronn, Germany
Herbolzheim, Germany
Karlsruhe, Germany
Kehl, Germany
Koblenz, Germany
Lauffen, Germany
Mannheim, Germany
Marbach, Germany
Mönchengladbach, Germany
München, Germany
Neustadt a.d. Aisch, Germany
Nidderau, Germany
Oberhausen, Germany
Oberkirch, Germany
Offenburg, Germany
Pegnitz, Germany
Rodorf, Germany
Schwieberdingen, Germany
Schwäbisch Hall, Germany
Traunreut, Germany
Veitshöchheim, Germany
Wanzleben, Germany
Welzheim, Germany
Wildeshausen, Germany
Zwiesel, Germany
Italy
Chiavari, Italy
Ferrara, Italy
Latisana, Italy
Ragusa, Italy
Sassari, Italy
Taranto, Italy
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Anne Fiquet, MD SPMSD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00432042     History of Changes
Other Study ID Numbers: V221-035
X06-MMRV-302 ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number )
First Submitted: February 5, 2007
First Posted: February 6, 2007
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Mumps and Rubella
Haemophilus influenzae type b (Infanrix® hexa)

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Measles
Chickenpox
Herpes Zoster
Poliomyelitis
Rubella
Haemophilus Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Herpesviridae Infections
Enterovirus Infections
Picornaviridae Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases


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