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OpenTrials
Completed

NCT Number: NCT00808444

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

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Key information

Age range

6 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Kuala Lumpur, Malaysia

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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 subjects between, and including 6-12 weeks of age at the time of the first vaccination.
  • Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
  • Born after a gestation period of >= 36 to <= 42 weeks.

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 the study vaccines, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
  • History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of any neurological disorders or seizures.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Treatment and study plan

Pneumococcal conjugate vaccine GSK1024850A (different lots)

Biological

Intramuscular injection, 3 doses

Infanrix hexa

Biological

Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore

Other names: DTPa-combined vaccine

Infanrix-IPV/Hib

Biological

Intramuscular injection, only for Visit 2 in Singapore

Other names: DTPa-combined vaccine

Rotarix

Biological

Oral, 2 doses

Other names: HRV vaccine

Primary outcomes

  1. Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine

    Time frame: One month after primary immunization (month 4)

    Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL).

    Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  2. Concentration of Antibody Against Protein D (PD)

    Time frame: One month after primary immunization (month 4)

    Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Secondary outcomes

  1. Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL

    Time frame: One month after primary immunization (month 4)

    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  2. Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL

    Time frame: One month after primary immunization (month 4)

    Anti-pneumococcal cross-reactive serotypes were 6A and 19A.

  3. Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 4)

    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

    Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

  4. Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 4)

    Cross-reactive pneumococcal serotypes were 6A and 19A.

    Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

  5. Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 4)

    Opsonophagocytic titers were expressed as GMTs.

    Cross-reactive pneumococcal serotypes included 6A and 19A.

  6. Poliovirus Types 1, 2 and 3 Titers

    Time frame: One month after primary immunization (month 4)

    Titers were given as Geometric Mean Titers (GMTs).

  7. Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)

    Time frame: One month after primary immunization (month 4)

    Concentrations were defined as GMCs in international units per milliter (IU/mL)

  8. Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).

    Time frame: One month after primary immunization (month 4)

    Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.

  9. Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)

    Time frame: 3 months after primary immunization (month 4)

    Concentration was expressed as GMC in units per milliliter (U/mL).

  10. Occurrence of Serious Adverse Events

    Time frame: Following vaccination and throughout the entire study period (Month 0 to Month 4)

    SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

  11. Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 4)

    Titers are presented as Geometric Mean Titers (GMTs).

    Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

  12. Number of Subjects With Solicited Local and General Symptoms.

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

    Solicited local symptoms were pain, redness and swelling.

    Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.

  13. Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)

    Time frame: One month after primary immunization (month 4)

    Concentrations are expressed as GMCs in EL.U/mL.

  14. Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)

    Time frame: One month after primary immunization (month 4)

    Concentrain was expressed as GMC in µg/mL.

  15. Occurrence of Unsolicited Adverse Events

    Time frame: Within 31 days (day 0-30) after 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Non-inferiority of a Commercial Lot of the Pneumococcal Vaccine GSK1024850A Compared to a Clinical Lot.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 15, 2008
Registry last updated
Aug 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.

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