Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 421
- Locations
- 9
- Primary Endpoint
- Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
Study Overview
Brief Summary
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.
Detailed Description
In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 8 Weeks to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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.
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 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.
Arms & Interventions
GSK2202083A + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: GSK2202083A vaccine (Biological)
GSK2202083A + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: 10-valent pneumococcal vaccine (GSK 1024850A) (Biological)
INFANRIX HEXA + MENJUGATE GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: Menjugate® (Biological)
INFANRIX HEXA + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: 10-valent pneumococcal vaccine (GSK 1024850A) (Biological)
INFANRIX HEXA + SYNFLORIX GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: Infanrix hexa™ (Biological)
INFANRIX HEXA + MENJUGATE GROUP
Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Intervention: Infanrix hexa™ (Biological)
Outcomes
Primary Outcomes
Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
Time Frame: At Month 3
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
Time Frame: At Month 3
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
Secondary Outcomes
- Anti-HBs Antibody Concentrations(At Month 3)
- Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)(At Month 3)
- Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations(At Months 0 and 3)
- Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN(At Month 3)
- Anti-PD Antibody Concentrations(At Month 3)
- Number of Subjects With Any Solicited Local Symptoms(During the 8-day (Days 0-7) post-vaccination period after any vaccination)
- Number of Subjects With Any Solicited General Symptoms(During the 8-day (Days 0-7) post-vaccination period after any vaccination)
- Anti-PSC Antibody Concentrations(At Months 0 and 3)
- Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)(At Month 3)
- Anti-D and Anti-T Antibody Concentrations(At Month 3)
- Anti-PRP Antibody Concentrations(At Months 0 and 3)
- Antibody Titers Against rSBA-MenC(At Months 0 and 3)
- Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)(At Month 3)
- Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)(At Month 3)
- Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3(At Month 3)
- Anti-polio Types 1, 2 and 3 Antibody Titers(At Month 3)
- Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes(At Month 3)
- Anti-pneumo Antibody Concentrations(At Month 3)
- Number of Seropositive Subjects for Anti-protein D (Anti-PD)(At Month 3)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-vaccination period after any vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Month 0 to Month 3))