Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

NCT ID: NCT00985751

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-24
• Study Completion Date: 2011-03-02

Brief Summary

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A (formulation 1)

Intervention Type: BIOLOGICAL

Three doses will be administered intramuscularly, at Month 0, 2 and 6.

Group 2

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A (formulation 2)

Intervention Type: BIOLOGICAL

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Group 3

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Intervention Type: BIOLOGICAL

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Group 4

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

Intervention Type: BIOLOGICAL

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Control Group

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK1024850A

Intervention Type: BIOLOGICAL

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Interventions

Pneumococcal vaccine GSK2189242A (formulation 1)

Three doses will be administered intramuscularly, at Month 0, 2 and 6.

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK2189242A (formulation 2)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK1024850A

Three doses will be administered intramuscularly, at Month 0, 2 and 6

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
• Written informed consent obtained from the parents/LAR(s) of the subject.
• 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) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
• Previous vaccination against S. pneumoniae since birth.
• History of any hypersensitivity reaction following any previous vaccination.
• Eczema and any history of allergy
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
• Child in care.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 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

Chomutov, , Czechia

GSK Investigational Site

Děčín, , Czechia

GSK Investigational Site

Náchod, , Czechia

GSK Investigational Site

Odolena Voda, , Czechia

GSK Investigational Site

Ostrava - Poruba, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Znojmo, , Czechia

Countries

Czechia

References

Prymula R, Pazdiora P, Traskine M, Ruggeberg JU, Borys D. Safety and immunogenicity of an investigational vaccine containing two common pneumococcal proteins in toddlers: a phase II randomized clinical trial. Vaccine. 2014 May 23;32(25):3025-34. doi: 10.1016/j.vaccine.2014.03.066. Epub 2014 Apr 1.

Reference Type: BACKGROUND

PMID: 24699466 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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

2009-012701-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113171

Identifier Type: -

Identifier Source: org_study_id