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Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
This study has been completed.
First Received: June 26, 2006   Last Updated: September 25, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00345579
  Purpose

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007


Condition Intervention Phase
Haemophilus Influenza Infections
Meningococcal Infection
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
Biological: ActHIB
Biological: Pediarix/Infanrix Penta
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety Study
Official Title: Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects Reporting Specific Adverse Events During the Active Phase of the Study [ Time Frame: From Day 0 after Dose 1 up to Day 30 after Dose 3 ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Specific Adverse Events Throughout the Entire Study [ Time Frame: From Day 0 until the end of the 6-month extended safety follow-up (ESFU) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome measures for the primary vaccination [ Designated as safety issue: No ]

Enrollment: 4429
Study Start Date: September 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Licensed Haemophilus Influenzae Type b Vaccine Group: Active Comparator
Subjects in both pooled studies received 3 intramuscular doses of Sanofi Pasteur's ActHIB vaccine co-administered with GSK Biologicals' Pediarix (Infanrix-Penta) and Wyeth's Prevnar.
Biological: ActHIB
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection
Experimental GSK792014 Vaccine Group: Experimental
Subjects in both pooled studies received 3 intramuscular doses of experimental GSK792014 vaccine co-administered with GSK Biologicals' Pediarix (Infanrix-Penta) and Wyeth's Prevnar.
Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
3-dose intramuscular injection
Biological: Pediarix/Infanrix Penta
3-dose intramuscular injection

Detailed Description:

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after 36 weeks gestation.
  • Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
  • Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
  • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345579

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35235
GSK Investigational Site
Birmingham, Alabama, United States, 35244
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
GSK Investigational Site
Benton, Arkansas, United States, 72015
United States, California
GSK Investigational Site
Fresno, California, United States, 93726
GSK Investigational Site
West Covina, California, United States, 91790
GSK Investigational Site
Slinas, California, United States, 93901
GSK Investigational Site
Madera, California, United States, 93637
GSK Investigational Site
Fresno, California, United States, 93710
GSK Investigational Site
Fountain Valley, California, United States, 92708
United States, Colorado
GSK Investigational Site
Longmont, Colorado, United States, 80501
GSK Investigational Site
Boulder, Colorado, United States, 80303
United States, Florida
GSK Investigational Site
Plantation, Florida, United States, 33324
United States, Idaho
GSK Investigational Site
Nampa, Idaho, United States, 208 463 3126
United States, Iowa
GSK Investigational Site
Waukee, Iowa, United States, 50263
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Louisiana
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
GSK Investigational Site
Jamaica Plain, Massachusetts, United States, 02130
United States, Michigan
GSK Investigational Site
Portage, Michigan, United States, 49024
GSK Investigational Site
Nies, Michigan, United States, 49120
GSK Investigational Site
Stevensville, Michigan, United States, 49127
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New York
GSK Investigational Site
New Hartford, New York, United States, 13413
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Deerfield, North Carolina, United States, 28607
United States, Ohio
GSK Investigational Site
North Canton, Ohio, United States, 44720
GSK Investigational Site
South Euclid, Ohio, United States, 44121
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
GSK Investigational Site
Wexford, Pennsylvania, United States, 15090
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
GSK Investigational Site
Kingsport, Tennessee, United States, 37664
United States, Utah
GSK Investigational Site
South Jordan, Utah, United States, 84095
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Ogden, Utah, United States, 84405
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Pleasant Gorve, Utah, United States, 84062
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53792
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Mexico
GSK Investigational Site
Mexico, D.F., Mexico, 06720
GSK Investigational Site
Mexico city, Mexico, 04530
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 105987
Study First Received: June 26, 2006
Last Updated: September 25, 2009
ClinicalTrials.gov Identifier: NCT00345579     History of Changes
Health Authority: Mexico: Federal Commission for Protection Against Health Risks;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Infants
Humans
H. influenzae type B vaccine
Meningococcal vaccines
Neisseria meningitidis Vaccines, conjugate
Safety
Prophylaxis

Additional relevant MeSH terms:
Haemophilus Infections
Bacterial Infections
Pasteurellaceae Infections
Communicable Diseases
RNA Virus Infections
Orthomyxoviridae Infections
Infection
Gram-Negative Bacterial Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Meningococcal Infections
Influenza, Human
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 30, 2009