Last updated: 07/17/2024 15:20:43
Immunogenicity and safety study of GSK Biologicals’ GSK2202083A vaccine in healthy infants at 2, 3 and 4 months of age
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 2, 3 and 4 months of age
Trial description: This study will evaluate the safety and immunogenicity of GSK Biologicals’ GSK2202083A vaccine co-administered with GSK Biologicals’ 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of seroprotected subjects against Polyribosyl-Ribitol-Phosphate (PRP)
Timeframe: At Month 3
Number of seroprotected subjects against Neisseria meningitidis serogroup C using baby rabbit complement (rSBA-MenC)
Timeframe: At Month 3
Secondary outcomes:
Anti-PRP antibody concentrations
Timeframe: At Months 0 and 3
Antibody titers against rSBA-MenC
Timeframe: At Months 0 and 3
Number of seropositive subjects for anti-polysaccharide Neisseria meningitidis serogroup C (anti-PSC)
Timeframe: At Month 3
Anti-PSC antibody concentrations
Timeframe: At Months 0 and 3
Number of seroprotected subjects against diphtheria (D) and tetanus (T)
Timeframe: At Month 3
Anti-D and anti-T antibody concentrations
Timeframe: At Month 3
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
Timeframe: At Month 3
Anti-PT, anti-FHA and anti-PRN antibody concentrations
Timeframe: At Months 0 and 3
Number of subjects with a vaccine response to anti-PT, anti-FHA and anti-PRN
Timeframe: At Month 3
Number of seroprotected and seropositive subjects for anti-hepatitis B surface antigen (anti-HBs)
Timeframe: At Month 3
Anti-HBs antibody concentrations
Timeframe: At Month 3
Number of seroprotected subjects for anti-poliovirus (anti-polio) types 1, 2 and 3
Timeframe: At Month 3
Anti-polio types 1, 2 and 3 antibody titers
Timeframe: At Month 3
Number of seropositive subjects for anti-pneumococcal (anti-pneumo) serotypes
Timeframe: At Month 3
Anti-pneumo antibody concentrations
Timeframe: At Month 3
Number of seropositive subjects for anti-protein D (anti-PD)
Timeframe: At Month 3
Anti-PD antibody concentrations
Timeframe: At Month 3
Number of subjects with any solicited local symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of subjects with any solicited general symptoms
Timeframe: During the 8-day (Days 0-7) post-vaccination period after any vaccination
Number of subjects with unsolicited adverse events (AEs)
Timeframe: During the 31-day (Days 0-30) post-vaccination period after any vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Month 0 to Month 3)
Interventions:
Enrollment:
421
Primary completion date:
2010-27-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Szenborn L et al. (2013) A randomized, controlled trial to assess the immunogenicity and safety of a Heptavalent Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Hib and Meningococcal Serogroup C combination vaccine administered at 2, 3, 4 and 12–18 months of age. Pediatr Infect Dis J. 32(7):777-785.
Medical condition
Tetanus, Diphtheria, Haemophilus influenzae type b, Poliomyelitis, acellular pertussis, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus influenzae type b-Neisseria Meni
Product
GSK2202083A, SB444563
Collaborators
Not applicable
Study date(s)
August 2009 to January 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
8 - 12 weeks
Accepts healthy volunteers
Yes
- A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
- Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent/LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
Exclusion criteria:
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration during the study period.
- 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, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
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.
Trial location(s)
Showing 1 - 6 of 9 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
2010-27-01
Actual study completion date
2010-27-01
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
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