Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Nigerian Children
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).
Study Overview
Brief Summary
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Nigerian subjects previously enrolled in the primary vaccination study NCT00678301.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Months to 21 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who the 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 15-21 months of age at the time of visit
- •For the Pn-Pn group, subjects who completed the full vaccination course in study NCT
- •For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT
- •Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- •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)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
- •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.
- •Administration of any pneumococcal vaccine since the end of study NCT
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
- •Major congenital defects or serious chronic illness.
- •History of any progressive neurological disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study.
- •Child in care.
Arms & Interventions
Synflorix/Infanrix primed Group
Subjects previously primed with the Synflorix™ vaccine in the primary study 110521 (NCT00678301) received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Intervention: Pneumococcal vaccine GSK1024850A (Biological)
Synflorix/Infanrix primed Group
Subjects previously primed with the Synflorix™ vaccine in the primary study 110521 (NCT00678301) received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Intervention: InfanrixTM (Biological)
Synflorix/Infanrix unprimed Group
Unprimed subjects from the primary study 110521 (NCT00678301), not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Intervention: InfanrixTM (Biological)
Synflorix/Infanrix unprimed Group
Unprimed subjects from the primary study 110521 (NCT00678301), not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Intervention: Pneumococcal vaccine GSK1024850A (Biological)
Outcomes
Primary Outcomes
Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).
Time Frame: Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.
Grade 3 symptom = severe symptom that prevented normal activity. Solicited local symptoms assessed were pain, redness and swelling. Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite. Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Secondary Outcomes
- Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.(Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.(Within 4 days (Days 0-3) after vaccination.)
- Number of Subjects Reporting Unsolicited AEs.(Within 31 days (Days 0-30) after vaccination)
- Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.(Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group)
- Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.(One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group)
- Concentration of Antibodies Against Protein D (PD).(Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group)
- Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.(Within 4 days (Days 0-3) after vaccination.)
- Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.)
- Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.(One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group)