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Completed

NCT Number: NCT00907777

Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

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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 Streptococcus Pneumoniae

Age range

46 month–50 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Mannheim, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female between, and including, 46-50 months of age at the time of vaccination.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
  • Written informed consent obtained from both parents/guardians 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 vaccination, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
  • Administration of any pneumococcal vaccine since the end of study NCT00333450.
  • Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
  • History of any neurologic disorders or seizures
  • Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • History of hypotonic-hyporesponsive episode after any previous vaccination.
  • Major congenital defects or serious chronic illness.
  • History of invasive pneumococcal diseases.
  • Acute disease at the time of vaccination
  • Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Treatment and study plan

Pneumococcal conjugate vaccine GSK 1024850A

Biological

One dose of vaccine will be injected intramuscularly into the deltoid.

Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

Biological

One dose of vaccine will be injected intramuscularly into the deltoid.

Primary outcomes

  1. Vaccine Pneumococcal Serotype Antibody Concentrations

    Time frame: Before (PRE) and one month after (POST) the additional dose

    The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Secondary outcomes

  1. Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

    Time frame: Before (PRE) and one month after (POST) the additional dose

    The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

  2. Cross-reactive Pneumococcal Serotype Antibody Concentrations

    Time frame: Before (PRE) and one month after (POST) the additional dose

    The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

  3. Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

    Time frame: Before (PRE) and one month after (POST) the additional dose

    The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

  4. Anti-protein D Antibody Concentrations

    Time frame: Before (PRE) and one month after (POST) the additional dose

    The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

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

    Time frame: During the 8-day (Days 0-7) post-additional 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 (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.

  6. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

    Time frame: During the 8-day (Days 0-7) post-additional dose

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

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

    Time frame: Within 31 days (Day 0-30) post-additional vaccination

    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.

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

    Time frame: Throughout the entire study period (approximately 1 month per subject)

    An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 25, 2009
Registry last updated
Nov 23, 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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