Clinical trial NCT01090453: Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
Official title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tetanus
Hepatitis B
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Diphtheria
Neisseria Meningitidis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-03-22
Enrollment: 480
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' 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.


Eligibility criteria: 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 4.
* 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.

Primary outcomes:
measure: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Above the Cut-off
timeFrame: At Month 3
measure: Number of Subjects With Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC) Antibody Titers Above the Cut-off
timeFrame: At Month 3
Secondary outcomes:
measure: Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-offs
timeFrame: At Month 3, Month 10 and Month 11.
measure: Number of Subjects With rSBA-MenC Antibody Titers Above the Cut-offs
timeFrame: At Month 3, Month 10 and Month 11.
measure: Concentrations for Anti-PRP.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Titers for rSBA-MenC.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Above the Cut-off.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Concentrations for Anti-T and Anti-D.
timeFrame: At Month 3, Month 10 and Month 11.
measure: 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)
timeFrame: At Month 3, Month 10 and Month 11.
measure: Concentrations for Anti-HBs.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Number of Subjects With Anti-poliovirus (Anti-polio) Types 1, 2 and 3 Above the Cut-off.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Titers for Anti-polio 1, 2 and 3.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Number Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Above the Cut-off.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 3, Month 10 and Month 11.
measure: Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.
timeFrame: At Month 11.
measure: Number of Subjects With Anti-pneumococcal (Anti-PNE) Serotypes Above the Cut-offs.
timeFrame: At Month 3 and Month 11
measure: Concentrations for Anti-PNE Serotypes.
timeFrame: At Month 3 and Month 11
measure: Number of Subjects With Anti-PRP and rSBA-MenC Fold Increase Distribution.
timeFrame: At Month 11.
measure: Number of Subjects Reporting Any Solicited Local Symptoms.
timeFrame: During the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects Reporting Any Solicited General Symptoms.
timeFrame: During the 8-day (Days 0-7) post-vaccination period
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
timeFrame: Within the 31-day (Days 0-30) follow up period after vaccination
measure: Number of Subjects Reporting Any Serious Adverse Events (SAEs).
timeFrame: During the entire study period (Month 0 to Month 11)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Aix en Provence
country: France
facility: GSK Investigational Site
city: Dax
country: France
facility: GSK Investigational Site
city: Draguignan
country: France
facility: GSK Investigational Site
city: Essey les Nancy
country: France
facility: GSK Investigational Site
city: Floirac
country: France
facility: GSK Investigational Site
city: Le Havre
country: France
facility: GSK Investigational Site
city: Lingolsheim
country: France
facility: GSK Investigational Site
city: Nice
country: France
facility: GSK Investigational Site
city: Trélazé
country: France
facility: GSK Investigational Site
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Schwaebisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Berchtesgaden
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bindlach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Wolfenbuettel
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Heiligenhaus
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Loehne
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Porta Westfalica
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Solingen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Worms
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: