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Completed

NCT Number: NCT00513409

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

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Key information

Conditions

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

Age range

18 month–21 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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

  • Male or female between, and including, 18-21 months of age at the time of vaccination.
  • Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion criteria

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
  • 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 and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.

Treatment and study plan

Synflorix

Biological

Intramuscular injection, 1 or 2 doses

Infanrix hexa

Biological

1 Intramuscular injection

Other names: DTPa-HBV-IPV/Hib

Havrix

Biological

1 Intramuscular injection

Primary outcomes

  1. Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)

    Time frame: Within 4 days after the administration of any study vaccine dose

    Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).

Secondary outcomes

  1. Number of Subjects Reporting Solicited Local Symptoms

    Time frame: Within 4 days after the administration of any study vaccine dose

    Solicited local symptoms assessed include pain, redness and swelling.

  2. Number of Subjects Reporting Solicited General Symptoms

    Time frame: Within 4 days after the administration of any study vaccine dose

    Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.

    Fever was defined as rectal temperature ≥ 38 degrees Celsius.

  3. Number of Subjects Reporting Unsolicited Adverse Events

    Time frame: Within 31 days after the administration of any study vaccine dose

    An Adverse Event 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.

  4. Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study

    Time frame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)

    A serious adverse event (SAE) is any untoward medical occurrence that:

    results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

  5. Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period

    Time frame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)

    An SAE is any untoward medical occurrence that:

    results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

  6. Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the administration of Dose 2

    Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (μg/mL).

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

  7. Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the administration of Dose 2

    Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.

  8. Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the administration of Dose 2

    Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

  9. Anti-hepatitis A Virus Antibodies Concentration

    Time frame: Before (pre) and one month after (post) the administration of Dose 2

    Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).

  10. Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the administration of Dose 2

    Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 8, 2007
Registry last updated
Dec 19, 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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