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Completed

NCT Number: NCT00814710

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.

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Key information

Conditions

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

Age range

6 week–10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Kolkata, India

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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 6-10 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. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).

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, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • 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, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b 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.
  • Babies for which birth weight is < 2 kilogram.

Treatment and study plan

Pneumococcal conjugate vaccine GSK1024850A

Biological

Intramuscular injection, 3 doses

Tritanrix-HepB/Hib

Biological

Intramuscular injection, 3 doses

Other names: DTPw-HBV/Hib

Hiberix

Biological

Intramuscular injection, 3 doses

Other names: Hib

Tritanrix-HepB

Biological

Intramuscular injection, 3 doses

Other names: DTPw-HBV

Primary outcomes

  1. Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 3)

    Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

    Pneumococcal serotypes 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 3)

    Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Secondary outcomes

  1. Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 3)

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

    Cross-reactive pneumococcal serotypes included 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.

  2. Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value

    Time frame: One month after primary immunization

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

    The cut-off was defined as 0.20 microgram per milliliter (µg/mL).

  3. Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes

    Time frame: One month after primary immunization (month 3)

    Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.

  4. Number of Subjects Seropositive for Pneumococcal Serotypes

    Time frame: One month after primary immunization (month 3)

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

    Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL

  5. Number of Subjects Seropositive for Protein D (PD)

    Time frame: One month after primary immunization (month 3)

    Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.

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

    Time frame: One month after primary immunization (month 3)

    Concentration is expressed as GMC in µg/mL.

  7. Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)

    Time frame: One month after primary immunization (month 3)

    Concentrations were expressed as GMCs in international units per milliliter (IU/mL).

  8. Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)

    Time frame: One month after primary immunization (month 3)

    Concentration was expressed as GMC in EL.U/mL.

  9. Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).

    Time frame: One month after primary immunization (month 3)

    Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs 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 retesting/reanalysis.

  10. Number of Subjects Seropostive for B. Pertussis

    Time frame: One month after primary immunization (month 3)

    Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.

  11. Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)

    Time frame: One month after primary immunization (month 3)

    Seroprotection was defined as:

    Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.

  12. Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)

    Time frame: One month after primary immunization (month 3)

    Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.

  13. Number of Subjects With Solicited Local and General Symptoms

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

    Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.

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

    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.

    Unsolicited AE covers any AE 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

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

    Time frame: Following first vaccination (Month 0) throughout the entire study period (month 3)

    SAEs assessed include medical occurrences that result in death, are 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 25, 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.

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