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Completed

NCT Number: NCT00463437

Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).

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Key information

Conditions

Hepatitis B Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Body Temperature Changes Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Enterovirus Infections Fever Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Meningococcal Infections Myelitis Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Picornaviridae Infections Pneumococcal Infections Poliomyelitis RNA Virus Infections Signs and Symptoms Spinal Cord Diseases Streptococcal Infections Streptococcus Pneumoniae Vaccines Tetanus Virus Diseases

Age range

11 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bad Saulgau, Baden-Wurttemberg, Germany

Loading trial locations.

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

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 11-18 months of age at the time of the booster vaccination.
  • A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine.
  • 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

  • Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines).
  • Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • 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 three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).

Treatment and study plan

Pneumococcal conjugate vaccine GSK1024850A

Biological

Intramuscular injection, 1 dose.

Prevenar

Biological

Intramuscular injection, 1 dose.

Other names: Pneumococcal conjugate vaccine (Wyeth Lederle).

Infanrix hexa

Biological

Intramuscular injection, 1 dose. In Germany and Poland.

Other names: DTPa-HBV-IPV/Hib (GSK Biologicals).

Infanrix IPV Hib

Biological

Intramuscular injection, 1 dose. In Spain.

Other names: DTPa-IPV/Hib (GSK Biologicals).

Infanrix penta

Biological

Intramuscular injection, 1 dose. In Germany and Poland.

Other names: DTPa-HBV-IPV (GSK Biologicals).

Infanrix IPV

Biological

Intramuscular injection, 1 dose. In Spain.

Other names: DTPa-IPV (GSK Biologicals)

Meningitec

Biological

Intramuscular injection, 1 dose.

Other names: Meningococcal C conjugate vaccine (Wyeth).

NeisVac-C

Biological

Intramuscular injection, 1 dose.

Other names: Meningococcal C conjugate vaccine (Baxter).

Menitorix

Biological

Intramuscular injection, 1 dose.

Other names: Combined Hib-MenC vaccine (GSK Biologicals).

Primary outcomes

  1. Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)

    Time frame: During the 4-day (Day 0-3) period after the booster vaccination

    Fever was measured as rectal temperature.

Secondary outcomes

  1. Number of Subjects Reporting Solicited Local Symptoms

    Time frame: During the 4-day (Day 0-3) period after the booster vaccination

    Solicited local symptoms assessed include pain, redness and swelling.

  2. Number of Subjects Reporting Solicited General Symptoms

    Time frame: During the 4-day (Day 0-3) period after the booster vaccination

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

  3. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    Time frame: During the 31-day (Day 0-30) period after the booster 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.

  4. Number of Subjects Reporting Serious Adverse Events (SAE)

    Time frame: During the 31-day (Day 0-30) period after the booster vaccination

    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.

  5. Number of Subjects Reporting Serious Adverse Events (SAE)

    Time frame: From the beginning of the study up to the end of the extended 6-month safety follow-up period

    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 booster administration

    Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

    The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 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 booster administration

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

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

  8. Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the booster administration

    Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL).

    The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

  9. Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the booster administration

    Anti-pneumococcal antibody cut-off value assessed was ≥ 8.

    The cross-reactive pneumococcal serotypes assessed include 6A and 19A.

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

    Time frame: Before (pre) and one month after (post) the booster administration

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

  11. Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the booster administration

    Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.

  12. Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the booster administration

    Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.

  13. Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value

    Time frame: Before (pre) and one month after (post) the booster administration

    Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2007
Registry last updated
Jan 2, 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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