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Completed

NCT Number: NCT00970307

Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

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Key information

Conditions

Tetanus Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meni Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pasteurellaceae Infections Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

8 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Bydgoszcz, Poland

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About this study

In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
  • Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent/LAR 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 vaccines 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.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, 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, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • 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 if no other exclusion criteria is met:

  • Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Treatment and study plan

GSK2202083A vaccine

Biological

Intramuscular, three doses

10-valent pneumococcal vaccine (GSK 1024850A)

Biological

Intramuscular, three doses

Infanrix Hexa™

Biological

Intramuscular, three doses

Menjugate®

Biological

Intramuscular, two doses

Primary outcomes

  1. Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)

    Time frame: At Month 3

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).

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

    Time frame: At Month 3

    A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.

Secondary outcomes

  1. Anti-PRP Antibody Concentrations

    Time frame: At Months 0 and 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.15 µg/mL.

  2. Antibody Titers Against rSBA-MenC

    Time frame: At Months 0 and 3

    The seroprotection cut-off value of the assay was an antibody titer ≥ 1:8.

  3. Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)

    Time frame: At Month 3

    A seropositive subject was defined as a subject with anti-PSC antibody concentration ≥ 0.3 µg/mL.

  4. Anti-PSC Antibody Concentrations

    Time frame: At Months 0 and 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.3 µg/mL.

  5. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)

    Time frame: At Month 3

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

  6. Anti-D and Anti-T Antibody Concentrations

    Time frame: At Month 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off value of ≥ 0.1 IU/mL.

  7. Number of Seropositive Subjects for 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 subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

  8. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

    Time frame: At Months 0 and 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.

  9. Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN

    Time frame: At Month 3

    A subject with a vaccine response was defined as either an initially seronegative subject with anti-PT, anti-FHA or anti-PRN concentrations ≥ 5 EL.U/mL or an initially seropositive subjects with antibody concentrations one month after the primary vaccination ≥ 1 fold the-pre vaccination antibody concentration.

  10. Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)

    Time frame: At Month 3

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. A seropositive subject was defined as a subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

  11. Anti-HBs Antibody Concentrations

    Time frame: At Month 3

    Antibody concentrations were expressed as GMCs. The seroprotection cut-off used was of ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the CLIA approved by the FDA. The table shows updated results following partial or complete retesting/reanalysis.

  12. 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 subject with anti-polio type 1, 2 or 3 antibody titers ≥ 1:8.

  13. Anti-polio Types 1, 2 and 3 Antibody Titers

    Time frame: At Month 3

    Titers were expressed as geometric mean titers (GMTs) for the seroprotection cut-off value of ≥ 1:8.

  14. Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes

    Time frame: At Month 3

    A seropositive subject was defined as a subject with anti-pneumo concentrations ≥ 0.05 µg/mL. The anti-pneumo serotypes assessed were: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  15. Anti-pneumo Antibody Concentrations

    Time frame: At Month 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 0.05 µg/mL.

  16. Number of Seropositive Subjects for Anti-protein D (Anti-PD)

    Time frame: At Month 3

    A seropositive subject was defined as a subject with anti-PD concentrations ≥ 100 EL.U/mL.

  17. Anti-PD Antibody Concentrations

    Time frame: At Month 3

    Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 100 EL.U/mL.

  18. Number of Subjects With Any Solicited Local Symptoms

    Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination

    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a local symptom irrespective of intensity grade.

  19. Number of Subjects With Any Solicited General Symptoms

    Time frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥ 37.5°C). Any= incidence of a general symptom irrespective of intensity grade and relationship to vaccination.

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

    Time frame: During the 31-day (Days 0-30) post-vaccination period after any vaccination

    An unsolicited AE was 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.

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

    Time frame: During the entire study period (from Month 0 to Month 3)

    SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 2, 2009
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.

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