Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

NCT ID: NCT00792909

Last Updated: 2017-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-02
• Study Completion Date: 2009-07-02

Brief Summary

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

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 = 00307034)

Conditions

Infections, Streptococcal

Keywords

Pneumococcal vaccine; Pneumococcal disease; Safety; Immunogenicity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Synflorix™ Group 1

Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Synflorix™ Group 2

Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 1 dose

Unprimed Group

Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

Group Type: ACTIVE_COMPARATOR

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Intramuscular injection, 2 doses

Interventions

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 1 dose

Intervention Type: BIOLOGICAL

Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 2 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female between, and including, +- 36-46 months of age at the time of vaccination.
• For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/guardian(s) of the subject.
• Free of obvious health problems 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 vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
• For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
• For unprimed subjects: previous vaccination with any pneumococcal vaccine.
• Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
• History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine.
• Acute disease at the time of enrolment.

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 46 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Dlhá nad Oravou, , Slovakia

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Ružomberok, , Slovakia

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Slovakia; Sweden

References

Silfverdal SA, Skerlikova H, Zanova M, Papuchova D, Traskine M, Borys D, Schuerman L. Anamnestic immune response in 3- to 4-year-old children previously immunized with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine as 2-dose or 3-dose priming and a booster dose in the first year of life. Pediatr Infect Dis J. 2011 Sep;30(9):e155-63. doi: 10.1097/INF.0b013e31821feeb7.

Reference Type: BACKGROUND

PMID: 21572373 (View on PubMed)

Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Reference Type: BACKGROUND

Silfverdal SA et al. Immunogenicity/reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) during fourth year of life. Abstract presented at the 8th Biennial International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Foz de Iguaçu, Brazil, 11-15 March 2012.

Reference Type: BACKGROUND

Study Documents

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

111736

Identifier Type: -

Identifier Source: org_study_id