Skip to main content
OpenTrials
Completed

NCT Number: NCT00390910

Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants

This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis B virus-inactivated polio virus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.

This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number = 00609492)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Streptococcal Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Infections Obstetric Labor Complications Obstetric Labor, Premature Pneumococcal Infections Pregnancy Complications Premature Birth Streptococcal Infections Urogenital Diseases

Age range

8 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Athens, Greece

Loading trial locations.

About this study

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

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
  • A male or female between, and including, 8-16 weeks (56-118 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Born after a gestation period of >27 weeks (at least 189 days).
  • If full term born, healthy subjects as established by medical history and clinical examination before entering into the study
  • If premature, medically stable condition (not requiring significant medical support or ongoing management for debilitating disease and having demonstrated a clinical course of sustained recovery).

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month before the first dose of vaccines and up to Visit 6.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Neisseria meningitidis and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, Neisseria meningitidis.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurologic disorders or seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past).
  • Acute disease at the time of enrolment.
  • 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 one month preceding the first dose of study vaccines or planned administration during the active phase of the study.

Treatment and study plan

Pneumococcal conjugate vaccine GSK1024850A

Biological

Intramuscular injection, 3 doses

Infanrix hexa

Biological

Intramuscular injection, 3 doses

Other names: DTPa-HBV-IPV/Hib

Primary outcomes

  1. Number of Subjects With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

    Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

    Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.

Secondary outcomes

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

    Time frame: Within 4 days (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

    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 greater than (>) 30 millimeters (mm). "Any" was 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 (Days 0-3) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

    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" was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.

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

    Time frame: Within 31 days (Days 0-30) after each vaccine dose, administered according to a 3-dose schedule at 2-4-6 months of age (Month 0-2-4)

    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" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.

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

    Time frame: Throughout the active phase of the study (from the first vaccine administration (Month 0) up to 1 month after the third vaccine administration (Month5).

    Serious adverse events (SAEs) assessed included 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 Any Serious Adverse Events (SAEs)

    Time frame: Throughout the entire study period starting from the first vaccine dose administration (Month 0) up to the end of the 6-month safety follow-up (ESFU- Month 10).

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

  6. Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Greater Than or Equal to (≥) the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 0.20 microgram per mililiter (μg/ mL).

  7. Number of Subjects With Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 0.05 microgram per mililiter (μg/mL).

  8. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

    Time frame: One month after the 3rd vaccine dose (Month 5)

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

  9. Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 8

  10. Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

    Time frame: One month after the 3rd vaccine dose (Month 5)

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

  11. Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).

  12. Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations ≥ 0.05 microgram per milliliter (μg/mL).

  13. Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 8.

  14. Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seropositivity status was defined as opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8.

  15. Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 100 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  16. Concentrations of Antibodies Against Protein D (Anti-PD)

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seropositivity status was defined as anti-PD antibody concentrations ≥ 100 ELISA units per milliliter ( EL.U/mL).

  17. Number of Subjects With Anti-diphtheria (Anti DT) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

  18. Antibody Concentrations for Anti-diphtheria and Tetanus Toxoids ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seroprotection status was defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations ≥ 0.1 IU/mL

  19. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 0.15 microgram per milliliter (μg/mL).

  20. Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 1.0 microgram per milliliter (μg/mL).

  21. Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations ≥ th Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seroprotection status was defined as anti-PRP antibody concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL

  22. Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 5 ELISA unit per milliliter (EL.U/mL).

  23. Antibody Concentration for Anti-pertussis Toxoid (Anti-PT) , Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seropositivity status was defined as anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ 5 EL.U/mL.

  24. Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off.

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 10 milli-international units per milliliter (mIU/mL).

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

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seroprotection status was defined as Anti-HBs antibody concentrations ≥ 10 mIU/mL

  26. Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titres

    Time frame: One month after the 3rd vaccine dose (Month 5)

    The cut-off for the assay was ≥ 8.

  27. Antibody Titers for Polio Type 1, 2 and 3 ≥ the Cut-off

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Seroprotection status was defined as Anti-polio type 1, Anti-polio type 2 and Anti-polio type 3 antibody titers ≥ 8.

  28. Number of Subjects With Vaccine Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)

    Time frame: One month after the 3rd vaccine dose (Month 5)

    Vaccine response to PT, FHA and PRN was defined as appearance of antibodies in subjects who are initially seronegative (S-), or at least maintenance of pre-vaccination antibody concentrations in those who are initially seropositive (S+). For the SYNFLORIX™ + INFANRIX™ HEXA GROUP I, no subjects presented initial seropositivity for PT and PRN antigens.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study to Assess the Safety and Immunogenicity of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine When Co-administered With DTPa-HBV-IPV/Hib (Infanrix-Hexa) Vaccine in Preterm Infants as a 3-dose Primary Immunization Course During the First 6 Months of Life.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Oct 23, 2006
Registry last updated
Dec 17, 2018

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.