Last updated: 11/03/2018 08:40:28
Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 2, 4, 6 and 12 to 15 months of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A single-blind, randomized, controlled, multinational study for the evaluation of safety of GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen compared to monovalent Haemophilus influenzae type b (Hib) control vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.
Trial description: 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
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of subjects reporting New Onset of Chronic Illnesses (NOCIs)
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of subjects reporting rash
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of subjects reporting Adverse Events resulting in Emergency Room (ER)
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of subjects with Serious Adverse Events (SAEs)
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of subjects with New Onset of Chronic illnesses (NOCIs)
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of subjects with rash
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of subjects with Adverse Events resulting in Emergency Room (ER)
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014
Biological/vaccine: ActHIB
Biological/vaccine: Pediarix/Infanrix Penta
Enrollment:
4432
Observational study model:
Not applicable
Primary completion date:
2007-27-10
Time perspective:
Not applicable
Clinical publications:
Bryant KA et al. (2011) Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines.10(7):941-950.
Rinderknecht S et al. (2012) The safety profile of Haemophilus influenzae type b–Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 8(3). [Epub ahead of print].
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB217744, SB792014
Collaborators
Not applicable
Study date(s)
September 2006 to March 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Deerfield, North Carolina, United States, 28607
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80303
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35244
Status
Study Complete
Location
GSK Investigational Site
Pleasant Gorve, Utah, United States, 84062
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Location
GSK Investigational Site
Clyde, North Carolina, United States, 28721
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Akron, Ohio, United States, 44308-1062
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Hartford, New York, United States, 13413
Status
Study Complete
Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Katy, Texas, United States, 77450
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fresno, California, United States, 93726
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93710
Status
Study Complete
Location
GSK Investigational Site
North Canton, Ohio, United States, 44720
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete
Location
GSK Investigational Site
South Euclid, Ohio, United States, 44121
Status
Study Complete
Location
GSK Investigational Site
Nampa, Idaho, United States, 208 463 3126
Status
Study Complete
Location
GSK Investigational Site
Wexford, Pennsylvania, United States, 15090
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Location
GSK Investigational Site
Sylva, North Carolina, United States, 28779
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portage, Michigan, United States, 49024
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37664
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Jamaica Plain, Massachusetts, United States, 02130
Status
Study Complete
Location
GSK Investigational Site
Slinas, California, United States, 93901
Status
Study Complete
Location
GSK Investigational Site
Benton, Arkansas, United States, 72015
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oaklawn, Illinois, United States, 60453
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77084
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madera, California, United States, 93637
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
Status
Study Complete
Location
GSK Investigational Site
Longmont, Colorado, United States, 80501
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-27-10
Actual study completion date
2008-28-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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