Clinical trial NCT01204658: Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Official title: Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Streptococcal
Keywords: Haemophilus influenzae
Streptococcus pneumoniae
immunogenicity
Pneumococcal vaccine
infants
safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 576
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Detailed description: This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A \[high dose (HD) or low dose (LD)\] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
* Male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parents/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

* Child in care.
* 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.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.
* 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.
* Previous vaccination against S. pneumoniae since birth.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or any chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature \>= 38.0°C on rectal setting or \>= 37.5°C on oral or axillary setting.
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
* Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.

Primary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
timeFrame: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course
measure: Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses
measure: Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses
Secondary outcomes:
measure: Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study
timeFrame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
timeFrame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
timeFrame: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
timeFrame: Within the 7-day (Days 0-6) period after booster vaccination
measure: Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
timeFrame: Within the 7-day (Days 0-6) period post vaccination after booster vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study
timeFrame: Within the 31-day (Days 0-30) period post primary vaccination, across doses
measure: Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study
timeFrame: Within the 31-day (Days 0-30) period post booster vaccination
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Months 0-11)
Other outcomes:
Locations:
city: Benesov
country: Czechia
facility: GSK Investigational Site
city: Brno
country: Czechia
facility: GSK Investigational Site
city: Decin
country: Czechia
facility: GSK Investigational Site
city: Jindrichuv Hradec
country: Czechia
facility: GSK Investigational Site
city: Kladno
country: Czechia
facility: GSK Investigational Site
city: Liberec
country: Czechia
facility: GSK Investigational Site
city: Nachod
country: Czechia
facility: GSK Investigational Site
city: Ostrov
country: Czechia
facility: GSK Investigational Site
city: Pardubice
country: Czechia
facility: GSK Investigational Site
city: Praha 6
country: Czechia
facility: GSK Investigational Site
city: Schwäbisch-Hall
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Detmold
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Debica
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Siemianowice Slaskie
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Umeå
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
city: Östersund
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Prymula R, Szenborn L, Silfverdal SA, Wysocki J, Albrecht P, Traskine M, Gardev A, Song Y, Borys D. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants. Vaccine. 2017 Aug 16;35(35 Pt B):4603-4611. doi: 10.1016/j.vaccine.2017.07.008. Epub 2017 Jul 17.