Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

Treatments: Biological: Pneumococcal vaccine GSK1024850A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985465

113166

Details and patient eligibility

About

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).

Enrollment: 218 patients

Sex: All

Ages: 15 to 21 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

218 participants in 2 patient groups

Pn-Pn group

Experimental group

Description:

subjects from the Pn-Pn group, previously vaccinated with pneumococcal conjugate vaccine GSK1024850A in the Malian centre of study NCT00678301, receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A

Treatment:

Biological: Pneumococcal vaccine GSK1024850A

Zil-Pn group

Experimental group

Description:

subjects from the unprimed group of the NCT00678301 Malian study centre, not previously vaccinated with any pneumococcal vaccine, receiving two doses of pneumococcal conjugate vaccine GSK1024850A

Treatment:

Biological: Pneumococcal vaccine GSK1024850A