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Infections, StreptococcalPhase 2NCT00985751

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

A Phase 2 study testing Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2) and Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) in people with Infections, Streptococcal, run by GlaxoSmithKline at 10 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Streptococcal
What is being tested?
Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2) and Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
10 sitesCzechia
Study dates
24 Nov 2009to 2 Mar 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 23 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Czechia10 sites

  • GSK Investigational Site

    Chomutov, 43003

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Odolena Voda, 25070

  • GSK Investigational Site

    Ostrava - Poruba, 70868

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 1600

  • GSK Investigational Site

    Znojmo, 669 00

Other trials in Czechia

About this study

Official title: Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen in Children Aged 12-23 Months at the Time of First Vaccination.

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).

Being tested
Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2), Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3), Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4), Pneumococcal vaccine GSK1024850A
Keywords
immunogenicity, toddlers, Pneumococcal vaccine, Haemophilus influenzae, safety, Streptococcus pneumoniae, Streptococcus Pneumoniae Vaccines
Medical subject headings
Streptococcal Infections, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal vaccine GSK2189242A (formulation 1)Biological

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

  • Pneumococcal vaccine GSK2189242A (formulation 2)Biological

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

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

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

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

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

  • Pneumococcal vaccine GSK1024850ABiological

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

Study groups in NCT00985751
Study groupRoleWhat they receive
Group 1ExperimentalNot described
Receives: Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Group 2ExperimentalNot described
Receives: Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Group 3ExperimentalNot described
Receives: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Group 4ExperimentalNot described
Receives: Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Control GroupExperimentalNot described
Receives: Biological: Pneumococcal vaccine GSK1024850A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

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

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

    Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

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

  3. Number of Subjects With Unsolicited Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

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

  4. Number of Subjects With Unsolicited Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

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

  5. Number of Subjects With Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

    Measured: 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)

  6. Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations

    Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.

    Measured: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  7. Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations

    Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).

    Measured: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  8. Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes

    Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.

    Measured: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  9. Antibody Concentrations to Protein D (Anti-PD)

    Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).

    Measured: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

  10. Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity

    Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.

    Measured: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2009 (estimated)
  2. Study start24 Nov 2009
  3. Primary completion12 Oct 2010
  4. Study completion2 Mar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00985751
Sponsor's protocol ID
113171
Other IDs
2009-012701-19, 2009
Status last verified
Oct 2020
First submitted
24 Sep 2009
Last updated
5 Nov 2020
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 24699466

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal vaccine GSK2189242A (formulation 1), Pneumococcal vaccine GSK2189242A (formulation 2) and Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) in people with Infections, Streptococcal, run by GlaxoSmithKline at 10 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Fever > 40.0°C (Rectal Temperature) (time frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.

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