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

NCT00985751 | Completed Phase 2 Results

• 2 other identifiers: 1131712009-012701-19
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 10

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

Keywords

immunogenicity; toddlers; Pneumococcal vaccine; Haemophilus influenzae; safety; Streptococcus pneumoniae; Streptococcus Pneumoniae Vaccines

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Fever > 40.0°C (Rectal Temperature)

  The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.

  Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination

Secondary Outcomes (10)

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

  During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)

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

  During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 0-30) follow-up period after each primary dose

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 0-30) follow-up period after the booster dose

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)

Study Arms (5)

Group 1

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A (formulation 1)

Group 2

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

Group 3

EXPERIMENTAL

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

Group 4

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK1024850A

Interventions

Pneumococcal vaccine GSK2189242A (formulation 1) BIOLOGICAL

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

Group 1

Pneumococcal vaccine GSK2189242A (formulation 2) BIOLOGICAL

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

Group 2

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

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

Group 3

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

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

Group 4

Pneumococcal vaccine GSK1024850A BIOLOGICAL

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

Control Group

Eligibility Criteria

• Age: 12 Months - 23 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) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Chomutov, 43003, Czechia

Location

GSK Investigational Site

Děčín, 405 01, Czechia

Location

GSK Investigational Site

Náchod, 547 01, Czechia

Location

GSK Investigational Site

Odolena Voda, 25070, Czechia

Location

GSK Investigational Site

Ostrava - Poruba, 70868, Czechia

Location

GSK Investigational Site

Pardubice, 532 03, Czechia

Location

GSK Investigational Site

Pilsen, 305 99, Czechia

Location

GSK Investigational Site

Prague, 140 00, Czechia

Location

GSK Investigational Site

Prague, 1600, Czechia

Location

GSK Investigational Site

Znojmo, 669 00, Czechia

Location

Related Publications (1)

• 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.

  PMID: 24699466 BACKGROUND

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; Haemophilus Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pasteurellaceae Infections; Gram-Negative Bacterial 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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 24, 2009
• Primary Completion: October 12, 2010
• Study Completion: March 2, 2011
• Last Updated: November 5, 2020
• Results First Posted: October 6, 2017

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CZ (10)