Clinical trial NCT00985465: Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
Official title: 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 Malian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Streptococcal
Keywords: Booster vaccination
Pneumococcal vaccine
Catch-up vaccination
Pneumococcal disease
Safety
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 218
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Malian 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).


Eligibility criteria: 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 1.
* For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301.
* 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 (drug or vaccine) 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 (pharmaceutical product or device).
* Administration of any pneumococcal vaccine since the end of study NCT00678301.
* 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.

Primary outcomes:
measure: Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
timeFrame: Within 31 days (Day 0-Day 30) after booster vaccination
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within 4 days (Day 0-Day 3) after the booster dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within 4 days (Day 0-Day 3) after the booster dose
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: Within 4 days (Day 0-Day 3) after each vaccine dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: Within 4 days (Day 0-Day 3) after each vaccine dose
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: Within 31 days (Day 0-Day 30) after each vaccine dose
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From the first vaccination up to one month (31 days) after the last vaccination for each subject
measure: Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
timeFrame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
measure: Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
timeFrame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
measure: Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
timeFrame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
measure: Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
timeFrame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
measure: Concentrations of Antibodies Against Protein D (PD)
timeFrame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dicko A, Santara G, Mahamar A, Sidibe Y, Barry A, Dicko Y, Diallo A, Dolo A, Doumbo O, Shafi F, Francois N, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of a booster dose of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Hum Vaccin Immunother. 2013 Feb;9(2):382-8. doi: 10.4161/hv.22692. Epub 2013 Jan 4.
citation: Dicko A et al. Safety and immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 7th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011 (Abstract 532).
citation: Dicko et al. Safety/reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) in Malian children. Abstract presented at the 8th International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Iguaçu Falls, Brazil, 11-15 March 2012 (Abstract 085).
citation: Dicko A, Dicko Y, Barry A, Sidibe Y, Mahamar A, Santara G, Dolo A, Diallo A, Doumbo O, Shafi F, Francois N, Yarzabal JP, Strezova A, Borys D, Schuerman L. Safety, reactogenicity and immunogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Malian children in the second year of life: Results from an open study. Hum Vaccin Immunother. 2015;11(9):2207-14. doi: 10.1080/21645515.2015.1016679.