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Completed

NCT Number: NCT00871338

Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

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Key information

Conditions

Neisseria Meningitidis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Infections Pasteurellaceae Infections

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Ely, Cambridgeshire, United Kingdom

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About this study

This protocol posting has been updated following Protocol amendment 1, 11-February-2010; The Study design section is impacted by this amendment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All subjects must satisfy the following criteria at study entry:

  • A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Born after 36 to 42 weeks of gestation.
  • 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.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • 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 since birth. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
  • History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.

The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

  • Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration

Treatment and study plan

GSK2197870A

Biological

3 doses given at 2, 3 and 4 months of age

Other names: GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, polio, HiB and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.

Prevenar™

Biological

3 co-administered doses, intramuscular into right thigh

Other names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

Menitorix™

Biological

1 booster dose at 12 months of age

Other names: GSK Biologicals' combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine.

Pediacel™

Biological

3 doses given at 2, 3 and 4 months of age

Other names: Sanofi-Pasteur-MSD's combined DTPa-inactivated polio-Haemophilus influenzae type b vaccine.

Menjugate™

Biological

2 doses given at 3 and 4 months of age

Other names: Novartis' meningococcal serogroup C CRM197 protein conjugated vaccine.

Primary outcomes

  1. Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).

    Time frame: At Month 3

    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

  2. Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)

    Time frame: At Month 2 and Month 3.

    A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.

Secondary outcomes

  1. Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.

    Time frame: At Month 3

    The reference cut-off was ≥ 1.0 micrograms per milliliter (µg/mL).

  2. Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.

    Time frame: At Month 2 and Month 3.

    The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.

  3. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

    Time frame: At Month 3.

    A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

  4. Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).

    Time frame: At Month 3.

    A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

  5. Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

    Time frame: At Month 3.

    A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.

  6. Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.

    Time frame: At Month 3

    A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.2 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 4, 6B, 9V, 14, 18C, 19F and 23F.

  7. Concentrations for Anti-PRP.

    Time frame: At Month 3.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.

  8. Titers for rSBA-MenC.

    Time frame: At Month 2 and Month 3.

    Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.

  9. Concentrations for Anti-PSC.

    Time frame: At Month 2 and Month 3.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.

  10. Concentrations for Anti-T and Anti-D.

    Time frame: At Month 3.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL.

  11. Concentrations for Anti-PT, Anti-FHA and Anti-PRN.

    Time frame: At Month 3.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.

  12. Titers for Anti-polio 1, 2 and 3.

    Time frame: At Month 3.

    Titers were expressed as geometric mean titers (GMTs). The seropositivity reference cut-off value was ≥ 1:8.

  13. Concentrations for Anti-PNE Serotypes.

    Time frame: At Month 3.

    Concentrations were expressed as geometric mean concentreations (GMCs). The seropositivity reference cut-off value was ≥ 0.2 µg/mL.

  14. Number of Seroprotected Subjects for Anti-PRP.

    Time frame: At Month 10 and Month 11.

    A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

  15. Number of Seropositive Subjects Against rSBA-MenC.

    Time frame: At Month 10 and Month 11.

    A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.

  16. Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.

    Time frame: At Month 10 and Month 11.

    The reference cut-offs were ≥ 0.3 µg/mL and ≥ 2 µg/mL.

  17. Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.

    Time frame: At Month 10.

    A seropositive subject was defined as a vaccinated subject who had anti-D (ELISA) and anti-T antibody concentrations ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).

  18. Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.

    Time frame: At Month 10.

    A seropositive subject was defined as a vaccinated subject who had anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

  19. Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.

    Time frame: At Month 10.

    A seroprotected subject was defined as a vaccinated subject who had anti-polio 1, 2 and 3 antibody concentrations ≥ 1:8.

  20. Concentrations for Anti-PRP.

    Time frame: At Month 10 and Month 11.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.15 µg/mL.

  21. Titers for rSBA-MenC.

    Time frame: At Month 10 and Month 11.

    Titers were expressed as geometric mean titers (GMCs). The seropositivity reference cut-off value was ≥ 1:8.

  22. Concentrations for Anti-PSC.

    Time frame: At Month 10 and Month 11.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.3 µg/mL.

  23. Concentrations for Anti-T and Anti-D.

    Time frame: At Month 10.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection reference cut-off value was ≥ 0.1 IU/mL. Seropositivity for anti-D was also defined with the ≥ 0.016 IU/mL cut-off (Neutralisation assay).

  24. Concentrations for Anti-PT, Anti-FHA and Anti-PRN.

    Time frame: At Month 10.

    Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity reference cut-off value was ≥ 5 EL.U/mL.

  25. Titers for Anti-polio 1, 2 and 3.

    Time frame: At Month 10.

    Titers were expressed as geometric mean titers (GMTs). The seroprotection reference cut-off value was ≥ 1:8.

  26. Number of Subjects With a Booster Response to rSBA-MenC Antibodies.

    Time frame: At Month 11

    Booster response defined as: for initially seronegative subjects, antibody titre ≥ 1:32 at post-booster (Month 11); for initially seropositive subjects, antibody titres at post-booster ≥ 4 fold the pre-booster.

  27. Number of Subjects With a Booster Response to Anti-PRP Antibodies.

    Time frame: At Month 11

    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 0.6 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.

  28. Number of Subjects With a Booster Response to Anti-PSC Antibodies.

    Time frame: At Month 11

    Booster response defined as: for initially seronegative subjects, antibody concentration ≥ 1.2 µg/mL at post-booster (Month 11); for initially seropositive subjects, antibody concentrations at post-booster ≥ 4 fold the pre-booster.

  29. Number of Subjects Reporting Any Solicited Local Symptoms.

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

    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

  30. Number of Subjects Reporting Any Solicited General Symptoms.

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

    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

  31. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).

    Time frame: Within the 31-day (Days 0-30) follow up period after vaccination.

    An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

  32. Number of Subjects Reporting Any Serious Adverse Events (SAEs).

    Time frame: During the entire study period (Month 0 to Month 11)

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study in Healthy Children of GSK Biologicals' DTPa-IPV/Hib-MenC-TT Vaccine, GSK2197870A, Co-administered With Prevenar™ as a Three-dose Primary Vaccination Course in Infancy Followed by a Booster Dose of Menitorix™ at 12 Months of Age

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2009
Registry last updated
Jun 6, 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.

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