Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 480
- Locations
- 34
- Primary Endpoint
- Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
Study Overview
Brief Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 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
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- •A male or female infant between, and including, 8 and 12 weeks at the time of the first vaccination.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •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.
Exclusion Criteria
- •Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth.
- •Child in care.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to the end of the study with the exception of inactivated influenza vaccines. The administration of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, pneumococcal, rotavirus and/or MenC vaccines is not allowed at any time during the study period but other vaccines are allowed during the period from one day after study Visit 3 to 31 days before study Visit
- •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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal, rotavirus and/or MenC vaccination or disease, including Hepatitis B virus vaccination at birth.
- •History of seizures or progressive neurological disease.
- •Subjects with history of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- •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 vaccine(s).
- •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 other moderate to severe illness within 24 hours of study vaccine administration.
- •Current gastrointestinal infection.
Arms & Interventions
GSK2202083A Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Rotarix™ (Biological)
GSK2202083A Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: GSK2202083A vaccine (Biological)
GSK2202083A Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Prevenar 13® (Biological)
Infanrix hexa Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Prevenar 13® (Biological)
Infanrix hexa Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Menjugate® (Biological)
Infanrix hexa Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Rotarix™ (Biological)
Infanrix hexa Group
Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
Intervention: Infanrix hexa™ (Biological)
Outcomes
Primary Outcomes
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
Time Frame: At Month 3
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
Time Frame: At Month 3
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
Secondary Outcomes
- Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PRP.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PT, Anti-FHA and Anti-PRN.(At Month 3, Month 10 and Month 11.)
- Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.(At Month 11.)
- Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.(At Month 3 and Month 11)
- Number of Subjects Reporting Any Solicited General Symptoms.(During the 8-day (Days 0-7) post-vaccination period)
- 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)(At Month 3, Month 10 and Month 11.)
- Number of Subjects Reporting Any Solicited Local Symptoms.(During the 8-day (Days 0-7) post-vaccination period)
- Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs(At Month 3, Month 10 and Month 11.)
- Titers for rSBA-MenC.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-T and Anti-D.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-HBs.(At Month 3, Month 10 and Month 11.)
- Titers for Anti-polio 1, 2 and 3.(At Month 3, Month 10 and Month 11.)
- Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.(At Month 3, Month 10 and Month 11.)
- Concentrations for Anti-PNE Serotypes.(At Month 3 and Month 11)
- Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.(At Month 11.)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).(Within the 31-day (Days 0-30) follow up period after vaccination)
- Number of Subjects Reporting Any Serious Adverse Events (SAEs).(During the entire study period (Month 0 to Month 11))