Clinical trial NCT01027845: Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A in Healthy Japanese Children
Official title: Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline Biologicals' Pneumococcal Vaccine GSK1024850A Following Primary and Booster Vaccination of Healthy Japanese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Pneumococcal disease
Immunogenicity
Booster vaccination
Pneumococcal vaccine
Primary vaccination
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 360
Sex: ALL
Minimum age (years): 90
Maximum age (years): 118
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will aim to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' 10-valent pneumococcal conjugate vaccine GSK1024850A when co-administered with Japanese DTPa vaccine as a 3-dose primary immunization course in healthy Japanese children at 3, 4 and 5 months of age and as a booster vaccination at 17-19 months of age.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator/co-investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
* A male or female between, and including, 90 and 118 days of age (3 months) at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/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:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), 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 period starting from 30 days before the first dose of study vaccine(s) and ending on the last study visit, with the exception of Haemophilus influenzae type b vaccine, Hepatitis B Vaccine, Bacille Calmette-Guérin vaccine, Oral Polio Vaccine, Japanese encephalitis, measles and rubella, varicella, mumps, and 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 (pharmaceutical product or device).
* Administration of any pneumococcal vaccine since birth except for the DTPa group for whom vaccination with a licensed pneumococcal vaccine by catch-up schedule will be allowed only if the 2 vaccine doses are administered between Study Visit 4 and 5, i.e. from the second blood sampling timepoint (Visit 4) onwards and up to 7 days before the booster dose of the DTPa vaccine.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* History of, or intercurrent diphtheria, tetanus, pertussis disease.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* Major congenital defects or serious chronic illness.
* History of any seizures or progressive neurological disease.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Child in care.
* Acute disease and/or fever at the time of enrolment.

Primary outcomes:
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
Secondary outcomes:
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes (Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16 ) and one month after booster (POST, at Month 15-17) immunization
measure: Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes (Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A (Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Concentrations of Antibodies Against Protein D (PD) (Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Concentrations of Antibodies Against Protein D (PD) (Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT)(Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Primary Immunization)
timeFrame: 1 month following primary immunization (at Month 3)
measure: Concentrations of Antibodies Against Pertussis (PT) and Filamentous Haemagglutinin (FHA)(Booster Immunization)
timeFrame: Prior to (PRE, at Month 14-16) and one month after booster (POST, at Month 15-17) immunization
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Primary Vaccination
timeFrame: During the 8-day (Days 0-7) after each primary vaccine dose
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Booster Vaccination
timeFrame: During the 8-day (Days 0-7) period following booster vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Primary Vaccination
timeFrame: During the 8-day (Days 0-7) after each primary vaccine dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Booster Vaccination
timeFrame: During the 8-day (Days 0-7) period following booster vaccination
measure: Number of Subjects With Unsolicited AEs After Primary Vaccination
timeFrame: Within the 31-day (Days 0-30) post-primary vaccination period, across doses
measure: Number of Subjects With Unsolicited AEs After Booster Vaccination
timeFrame: Within the 31-day (Days 0-30) post booster vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From study start at Month 0 up to study end at Month 15-17
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
city: Niigata
country: Japan
facility: GSK Investigational Site
city: Okayama
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Iwata S, Kawamura N, Kuroki H, Tokoeda Y, Miyazu M, Iwai A, Oishi T, Sato T, Suyama A, Francois N, Shafi F, Ruiz-Guinazu J, Borys D. Immunogenicity and safety of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with DTPa vaccine in Japanese children: A randomized, controlled study. Hum Vaccin Immunother. 2015;11(4):826-37. doi: 10.1080/21645515.2015.1012019.