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
Completed
Completed
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:
Biological/vaccine: GSK2202083A vaccine
Biological/vaccine: 10-valent pneumococcal vaccine (GSK 1024850A)
Biological/vaccine: Infanrix hexa™
Biological/vaccine: Menjugate®
Enrollment:
421
Observational study model:
Not applicable
Primary completion date:
2010-27-01
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)
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
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.
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