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

NCT00985465 | Completed Phase 3 Results

• 1 other identifier: 113166
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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).

Conditions

Infections, Streptococcal

Keywords

Booster vaccination; Pneumococcal vaccine; Catch-up vaccination; Pneumococcal disease; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)

  The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.

  Within 31 days (Day 0-Day 30) after booster vaccination

Secondary Outcomes (11)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Within 4 days (Day 0-Day 3) after the booster dose

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Within 4 days (Day 0-Day 3) after the booster dose

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Within 4 days (Day 0-Day 3) after each vaccine dose

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Within 4 days (Day 0-Day 3) after each vaccine dose

• Number of Subjects With Any Unsolicited Adverse Events (AEs)

  Within 31 days (Day 0-Day 30) after each vaccine dose

Study Arms (2)

Pn-Pn group

EXPERIMENTAL

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

Biological: Pneumococcal vaccine GSK1024850A

Zil-Pn group

EXPERIMENTAL

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

Biological: Pneumococcal vaccine GSK1024850A

Interventions

Pneumococcal vaccine GSK1024850A BIOLOGICAL

Intramuscular injection, 1 or 2 doses

Pn-Pn group; Zil-Pn group

Eligibility Criteria

• Age: 15 Months - 21 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bamako, Mali

Location

Related Publications (4)

• 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.

  PMID: 23291945 BACKGROUND

• 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).

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 26020101 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: November 12, 2009
• Primary Completion: June 26, 2010
• Study Completion: July 26, 2010
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

MA (1)