Clinical trial NCT00678301: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
Official title: Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Zilbrix™ Hib and Polio Sabin™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: pneumococcal conjugate vaccine
Streptococcus pneumoniae
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 365
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Detailed description: Vaccination course at 6, 10, 14 weeks of age.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
* Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use 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 (pharmaceutical product or device).
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (Hepatitis B immunoglobulins at birth are allowed).
* Previous vaccination against, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and/or Streptococcus pneumoniae.
* History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment. Study entry should be delayed until the illness has improved.
* Babies for which birth weight is \< 2 kilogram (if known) at Visit 1

Primary outcomes:
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Antibody Concentrations Against Protein D (Anti-PD Antibodies)
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
Secondary outcomes:
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Titers for Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Titers for Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Antibodies Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seroprotected Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seroprotected Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Anti-6A and -19A)
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Antibodies Against Protein D (Anti-PD Antibodies)
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations
timeFrame: At Month 3, one month after the administration of the third dose of Synflorix vaccine
measure: Number of Subjects Seropositive for Antibodies Against Bordetella Pertussis (Anti-BPT)
timeFrame: At Month 3, one month after the administration of the third dose of DTPw-HBV/Hib vaccine
measure: Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
measure: Number of Subjects Seroprotected Against Diphtheria (D) and Tetanus Toxoids (TT) Antigens
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
measure: Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
measure: Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP)
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
measure: Number of Subjects Seroprotected Against Polyribosyl-ribitol Phosphate (PRP) Antigens
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
measure: Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix -HepB /Hiberix vaccine
measure: Number of Subjects Seroprotected Against Anti-Hepatitis B Surface Antigens (HBs).
timeFrame: At Month 3, one month after the administration of the third dose of Tritanrix HepB/ Hiberix vaccine
measure: Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms
timeFrame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
measure: Number of Subjects With Any and Any Grade 3 and Related Solicited General Symptoms
timeFrame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
measure: Number of Subjects With Fever (Temperature Measured Rectally) > the Cut-off
timeFrame: Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: Throughout the entire study period, from Month 0 to Month 3
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: GSK Investigational Site
city: Ikeja / Lagos
country: Nigeria
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dicko A, Odusanya OO, Diallo AI, Santara G, Barry A, Dolo A, Diallo A, Kuyinu YA, Kehinde OA, Francois N, Borys D, Yarzabal JP, Moreira M, Schuerman L. Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in infants in Mali and Nigeria: a randomized controlled trial. BMC Public Health. 2011 Nov 23;11:882. doi: 10.1186/1471-2458-11-882.
citation: Odusanya OO, Kuyinu YA, Kehinde OA, Francois N, Yarzabal JP, Moreira M, Borys D, Schuerman L. Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal non-typeable haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Nigerian Infants: a randomised trial. Niger Postgrad Med J. 2013 Dec;20(4):272-81.
citation: Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.