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NCT Number: NCT00985751

Safety & Immunogenicity of Pneumococcal Vaccine 2189242A 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).

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Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Infections Pasteurellaceae Infections Streptococcal Infections

Age range

12 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Chomutov, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 GSK1024850A

Biological

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

Primary outcomes

  1. 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

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

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

    Time frame: 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)

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

  6. Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations

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

    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.

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

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

    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).

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

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

    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.

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

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

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

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

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

    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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 28, 2009
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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