Last updated: 11/03/2018 15:52:21
Safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (GSK217744)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (GSK217744) in primary infant vaccination
Trial description: This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Timeframe: At Month 0
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Timeframe: At Month 3
Concentrations for anti-pertussis toxoid (anti-PT) and anti-pertactin (anti-PRN) antibodies.
Timeframe: At Month 0
Concentrations for anti-pertussis toxoid (anti-PT) and anti-pertactin (anti-PRN) antibodies.
Timeframe: At Month 3
Number of seroprotected subjects for anti-polyribosyl-ribitol-phosphate (anti-PRP) antibodies.
Timeframe: At Month 3
Number of subjects with anti-hepatitis B (anti-HBs) antibody concentration equal to or above (≥) 10 and 100 milli-International units per milliliter (mIU/mL)
Timeframe: At Month 3
Concentrations for anti-HBs antibodies ≥ 10 and 100 mIU/mL
Timeframe: At Month 3
Secondary outcomes:
Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies.
Timeframe: At Months 0 and 3
Number of seropositive subjects for anti-pertussis toxoid (anti-PT) and anti-pertactin (anti-PRN) antibodies.
Timeframe: At Months 0 and 3
Concentrations for anti-polyribosyl-ribitol-phosphate (anti-PRP) antibodies.
Timeframe: At Month 3
Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes.
Timeframe: At Month 3
Concentrations for anti-PNE antibodies.
Timeframe: At Month 3
Number of subjects with a vaccine response to PT and PRN.
Timeframe: At Month 3
Number of subjects reporting any solicited local symptoms.
Timeframe: During the 8-day (Days 0-7)
Number of subjects reporting any solicited general symptoms.
Timeframe: During the 8-day (Days 0-7)
Number of subjects reporting any unsolicited adverse events (AEs).
Timeframe: Within the 31-day (Days 0-30) follow up period after vaccination.
Number of subjects reporting any serious adverse events (SAEs).
Timeframe: During the entire study period (Month 0 to Month 3)
Interventions:
Biological/vaccine: Infanrix hexa™
Biological/vaccine: Prevenar 13®
Biological/vaccine: GSK217744
Enrollment:
721
Observational study model:
Not applicable
Primary completion date:
2012-05-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tetanus, Poliomyelitis, Hepatitis B, Haemophilus influenzae type b, acellular pertussis, Diphtheria
Product
SB217744
Collaborators
Not applicable
Study date(s)
December 2010 to January 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
60 - 90 days
Accepts healthy volunteers
Yes
- A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
- Concurrently participating 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.
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
Child in care.
Trial location(s)
Location
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
Status
Study Complete
Study documents
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
2012-05-01
Actual study completion date
2012-05-01
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
Additional information
Not applicable
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