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
Study complete
Study complete
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:
Enrollment:
4432
Primary completion date:
2007-27-10
Observational study model:
Not applicable
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
- Inclusion Criteria:
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
Inclusion and exclusion criteria
Inclusion 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
Showing 1 - 6 of 63 Results
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
Study complete
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.
Additional information about the trial
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