Clinical trial NCT00970307: Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tetanus
Diphtheria
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Hepatitis B
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 421
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)
timeFrame: At Month 3
measure: Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)
timeFrame: At Month 3
Secondary outcomes:
measure: Anti-PRP Antibody Concentrations
timeFrame: At Months 0 and 3
measure: Antibody Titers Against rSBA-MenC
timeFrame: At Months 0 and 3
measure: Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)
timeFrame: At Month 3
measure: Anti-PSC Antibody Concentrations
timeFrame: At Months 0 and 3
measure: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)
timeFrame: At Month 3
measure: Anti-D and Anti-T Antibody Concentrations
timeFrame: At Month 3
measure: Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
timeFrame: At Month 3
measure: Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
timeFrame: At Months 0 and 3
measure: Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
timeFrame: At Month 3
measure: Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)
timeFrame: At Month 3
measure: Anti-HBs Antibody Concentrations
timeFrame: At Month 3
measure: Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3
timeFrame: At Month 3
measure: Anti-polio Types 1, 2 and 3 Antibody Titers
timeFrame: At Month 3
measure: Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes
timeFrame: At Month 3
measure: Anti-pneumo Antibody Concentrations
timeFrame: At Month 3
measure: Number of Seropositive Subjects for Anti-protein D (Anti-PD)
timeFrame: At Month 3
measure: Anti-PD Antibody Concentrations
timeFrame: At Month 3
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 8-day (Days 0-7) post-vaccination period after any vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period after any vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Month 0 to Month 3)
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Tarnow
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Trzebnica
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Szenborn L, Czajka H, Brzostek J, Konior R, Caubet M, Ulianov L, Leyssen M. 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. 2013 Jul;32(7):777-85. doi: 10.1097/INF.0b013e31828d6b20.