Skip to main content
OpenTrials
Completed

NCT Number: NCT00609492

Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections Streptococcus Pneumoniae Vaccines

Age range

16 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Athens, Greece

Loading trial locations.

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 parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
  • A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
  • History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures or progressive neurological disease
  • Acute disease at the time of enrolment.
  • Febrile illness defined as oral, axillary or tympanic temperature < 37.5°C / rectal temperature < 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.

Treatment and study plan

GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A)

Biological

Single dose, intramuscular injection

Infanrix™-IPV/Hib

Biological

Single dose, intramuscular injection

Primary outcomes

  1. Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C)

    Time frame: Within 4-days (Day 0-3) after booster vaccination

    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed within 4-days (Day 0-3) after booster vaccination of Synflorix™ and Infanrix™-IPV/Hib vaccine.

Secondary outcomes

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

    Time frame: Within 4-days (Day 0-3) after booster vaccination

    Solicited local symptoms assessed included 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 With Any and Grade 3 Solicited General Symptoms

    Time frame: Within 4-days (Day 0-3) after booster vaccination

    Solicited general symptoms assessed included 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 activity. 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.

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

    Time frame: Within 31-days (Day 0-30) after booster 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 as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

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

    Time frame: Throughout the active phase of the study (Month 0 to Month 1)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

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

    Time frame: Throughout the entire study period starting from Month 0 up to the end of the extended safety follow-up (Month 6)

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  6. Number of Seropositive Subjects for Anti-pneumococcal Serotypes

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

    A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C , 19F and 23F concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).

  7. Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seroprotected subjects was defined as a subject who had anti-pneumococcal serotypes antibody concentrations greater than or equal to (≥) the threshold value of 0.20 micrograms per milliliter (μg/mL). The anti-pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  8. Antibody Concentrations Against Pneumococcal Serotypes

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  9. Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

    A seropositive subject was defined as a subject who had the anti-pneumococcal serotypes 6A and 19A concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (μg/mL).

  10. Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations greater than or equal to (≥) the cut-off value of 0.05 micrograms per milliliter (µg/mL). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  11. Number of Seropositive Subjects for Protein D Antibodies (Anti-PD)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seropositive subject was defined as a subject who had anti-PD concentration greater than or equal to (≥) the value of 100 ELISA units per milliliter (EL.U/mL).

  12. Antibody Concentrations Against Protein D (Anti-PD)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the anti-protein D (Anti-PD) antibody concentrations greater than or equal to (≥) 100 ELISA units per milliliter (EL.U/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  13. Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seroprotected subject was defined as a subject who had anti-DT and anti-TT concentrations greater than or equal to (≥) the value of 0.1 international units per milliliter (IU/mL).

  14. Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the anti-diphtheria toxoid (Anti-DT) and anti-tetanus toxoid (Anti-TT) antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  15. Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seroprotected subject was defined as a subject who had anti-PRP concentrations greater than or equal to (≥) the value of 0.15 micrograms per milliliter (µg /mL).

  16. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    The concentration of anti-polyribosyl-ribitol phosphate (Anti-PRP) antibody assessed was greater than or equal to (≥) the value of 1.0 micrograms per milliliter (µg /mL).

  17. Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™ -IPV/Hib vaccine

    Seropositivity status was defined as the anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg /mL) and ≥ 1.0 µg/mL. Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  18. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seropositive subject was defined as a subject who had anti-PT, anti-FHA and anti-PRN concentrations greater than or equal to (≥) the value of 5 ELISA units per milliliter (EL.U/mL).

  19. Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the anti-pertussis toxoid (Anti-PT), anti-filamentous haemagglutinin (Anti-FHA) and anti-pertactin (Anti-PRN) antibody concentrations greater than or equal to (≥) 5 ELISA units per milliliter (EL.U /mL). Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs).

  20. Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies

    Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Vaccine response was defined as antibody concentrations ≥ 5 EL.U/mL at post-booster, for initially seronegative subjects (S-) (with concentrations < 5 EL.U/mL) and for initially seropositive subjects (S+) (with concentrations ≥ 5 EL.U/mL), antibody concentrations at post-booster ≥ 2 fold the pre-vaccination antibody concentration.

  21. Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3)

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seroprotected subject was defined as a subject who had anti-polio types 1, 2 and 3 titers greater than or equal to (≥) the value of 8.

  22. Antibody Titers Against Anti-polio Type 1, 2 and 3

    Time frame: Prior to (Pre-booster) and one month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seroprotection status was defined as the anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers greater than or equal to (≥) the cut-off value of 8, presented as geometric mean titers (GMTs).

  23. Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs)

    Time frame: Prior to (Pre-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seroprotection status was defined as the Anti-HBs antibody concentrations greater than or equal to (≥) 10 milli international units per milliliter (mIU/mL), presented as geometric mean concentrations (GMCs).

  24. Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes

    Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seropositive subject was defines as a subject with opsonophagocytic activity cut-off value greater than or equal to (≥) the value of 8. The vaccine pneumococcal serotypes investigated were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  25. Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes

    Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).

  26. Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A

    Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    A seropositive subject was defined as a subject with opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A greater than or equal to (≥) the cut-off value of 8.

  27. Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A

    Time frame: One month after (Post-booster) the administration of the booster dose of Synflorix™ vaccine co-administered with the booster dose of Infanrix™-IPV/Hib vaccine

    Seropositivity status was defined as the opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A, with a cut-off value greater than or equal to (≥) 8, presented as geometric mean titers (GMTs).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Safety, Reactogenicity and Immunogenicity Following Booster Dose of GSK Biologicals´ Pneumococcal Conjugate Vaccine When Co-administered With a Booster Dose of Infanrix-IPV/Hib in Preterm Born Children at 16-18 Months of Age

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 7, 2008
Registry last updated
Jan 3, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.