Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
December 27, 2019 updated by: GlaxoSmithKline
Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC 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).
Study Overview
Status
Completed
Conditions
Detailed Description
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
Interventional
Enrollment (Actual)
1437
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10315
- GSK Investigational Site
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Berlin, Germany, 10967
- GSK Investigational Site
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Berlin, Germany, 12627
- GSK Investigational Site
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Berlin, Germany, 12679
- GSK Investigational Site
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Berlin, Germany, 14197
- GSK Investigational Site
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Berlin, Germany, 13355
- GSK Investigational Site
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Baden-Wuerttemberg
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Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
- GSK Investigational Site
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Boennigheim, Baden-Wuerttemberg, Germany, 74357
- GSK Investigational Site
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Bretten, Baden-Wuerttemberg, Germany, 75015
- GSK Investigational Site
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Ettenheim, Baden-Wuerttemberg, Germany, 77955
- GSK Investigational Site
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Karlsruhe, Baden-Wuerttemberg, Germany, 76189
- GSK Investigational Site
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Kehl, Baden-Wuerttemberg, Germany, 77694
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Germany, 68167
- GSK Investigational Site
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Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
- GSK Investigational Site
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Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Germany, 70469
- GSK Investigational Site
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Tettnang, Baden-Wuerttemberg, Germany, 88069
- GSK Investigational Site
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Bayern
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Cham, Bayern, Germany, 93413
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81735
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81675
- GSK Investigational Site
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Noerdlingen, Bayern, Germany, 86720
- GSK Investigational Site
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Olching, Bayern, Germany, 82140
- GSK Investigational Site
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Roding, Bayern, Germany, 93426
- GSK Investigational Site
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Hessen
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Eschwege, Hessen, Germany, 37269
- GSK Investigational Site
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Niedernhausen, Hessen, Germany, 65527
- GSK Investigational Site
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Niedersachsen
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Wolfenbuettel, Niedersachsen, Germany, 38302
- GSK Investigational Site
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Nordrhein-Westfalen
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Hille, Nordrhein-Westfalen, Germany, 32479
- GSK Investigational Site
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Loehne, Nordrhein-Westfalen, Germany, 32584
- GSK Investigational Site
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Muenster, Nordrhein-Westfalen, Germany, 48163
- GSK Investigational Site
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Porta Westfalica, Nordrhein-Westfalen, Germany, 32457
- GSK Investigational Site
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Rheinland-Pfalz
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Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
- GSK Investigational Site
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Bodenheim, Rheinland-Pfalz, Germany, 55294
- GSK Investigational Site
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Frankenthal, Rheinland-Pfalz, Germany, 67227
- GSK Investigational Site
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Gerolstein, Rheinland-Pfalz, Germany, 54568
- GSK Investigational Site
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Mainz, Rheinland-Pfalz, Germany, 55131
- GSK Investigational Site
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Trier, Rheinland-Pfalz, Germany, 54290
- GSK Investigational Site
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Trier, Rheinland-Pfalz, Germany, 54294
- GSK Investigational Site
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Worms, Rheinland-Pfalz, Germany, 67547
- GSK Investigational Site
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Sachsen
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Doebeln, Sachsen, Germany, 04720
- GSK Investigational Site
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Singwitz, Sachsen, Germany, 02692
- GSK Investigational Site
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Thueringen
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Lobenstein, Thueringen, Germany, 07356
- GSK Investigational Site
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Weimar, Thueringen, Germany, 99425
- GSK Investigational Site
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Bydgoszcz, Poland, 85-021
- GSK Investigational Site
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Debica, Poland, 39-200
- GSK Investigational Site
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Krakow, Poland
- GSK Investigational Site
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Poznan, Poland, 61-709
- GSK Investigational Site
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Siemianowice Slaskie, Poland, 41-103
- GSK Investigational Site
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Tarnow, Poland, 33-100
- GSK Investigational Site
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Wola, Poland, 43-225
- GSK Investigational Site
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Bilbao, Spain, 48013
- GSK Investigational Site
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Blanes (Girona), Spain, 17300
- GSK Investigational Site
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Burgos, Spain, 09005
- GSK Investigational Site
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Madrid, Spain, 28047
- GSK Investigational Site
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Madrid, Spain, 28034
- GSK Investigational Site
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Madrid, Spain, 28035
- GSK Investigational Site
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Marid, Spain, 28040
- GSK Investigational Site
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Montgat/Barcelona, Spain, 08390
- GSK Investigational Site
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Málaga, Spain, 29011
- GSK Investigational Site
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Móstoles/Madrid, Spain, 28935
- GSK Investigational Site
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Sant Vicenç Dels Horts /Barcelona, Spain, 08620
- GSK Investigational Site
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Tona/Barcelona, Spain, 08551
- GSK Investigational Site
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Valladolid, Spain, 47010
- GSK Investigational Site
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Vélez-Málaga / Málaga, Spain, 29700
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
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Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
In Germany and Poland.
Other Names:
Intramuscular injection, 1 dose.
In Spain.
Other Names:
Intramuscular injection, 1 dose.
Other Names:
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Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
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Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
In Germany and Poland.
Other Names:
Intramuscular injection, 1 dose.
In Spain.
Other Names:
Intramuscular injection, 1 dose.
Other Names:
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Experimental: GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
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Intramuscular injection, 1 dose.
Intramuscular injection, 1 dose.
In Germany and Poland.
Other Names:
Intramuscular injection, 1 dose.
In Spain.
Other Names:
Intramuscular injection, 1 dose.
Other Names:
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Active Comparator: Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
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Intramuscular injection, 1 dose.
In Germany and Poland.
Other Names:
Intramuscular injection, 1 dose.
In Spain.
Other Names:
Intramuscular injection, 1 dose.
Other Names:
Intramuscular injection, 1 dose.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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Fever was measured as rectal temperature.
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During the 4-day (Day 0-3) period after the booster vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Subjects Reporting Solicited Local Symptoms
Time Frame: During the 4-day (Day 0-3) period after the booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling.
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During the 4-day (Day 0-3) period after the booster vaccination
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Number of Subjects Reporting Solicited General Symptoms
Time Frame: During the 4-day (Day 0-3) period after the booster vaccination
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Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
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During the 4-day (Day 0-3) period after the booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time Frame: During the 31-day (Day 0-30) period after the booster vaccination
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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.
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During the 31-day (Day 0-30) period after the booster vaccination
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Number of Subjects Reporting Serious Adverse Events (SAE)
Time Frame: During the 31-day (Day 0-30) period after the booster vaccination
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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.
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During the 31-day (Day 0-30) period after the booster vaccination
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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
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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.
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From the beginning of the study up to the end of the extended 6-month safety follow-up period
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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
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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. |
Before (pre) and one month after (post) the booster administration
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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
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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. |
Before (pre) and one month after (post) the booster administration
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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
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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. |
Before (pre) and one month after (post) the booster administration
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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
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Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A. |
Before (pre) and one month after (post) the booster administration
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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
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Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
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Before (pre) and one month after (post) the booster administration
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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
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Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.
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Before (pre) and one month after (post) the booster administration
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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
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Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.
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Before (pre) and one month after (post) the booster administration
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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
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Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.
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Before (pre) and one month after (post) the booster administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.
- Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.
- Wysocki J, Tejedor JC, Grunert D, Konior R, Garcia-Sicilia J, Knuf M, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S77-88. doi: 10.1097/INF.0b013e318199f609.
- Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 25, 2007
Primary Completion (Actual)
January 21, 2008
Study Completion (Actual)
June 14, 2008
Study Registration Dates
First Submitted
April 19, 2007
First Submitted That Met QC Criteria
April 19, 2007
First Posted (Estimate)
April 20, 2007
Study Record Updates
Last Update Posted (Actual)
January 2, 2020
Last Update Submitted That Met QC Criteria
December 27, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Pneumonia
- Lung Diseases
- Liver Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Pneumonia, Bacterial
- Corynebacterium Infections
- Hepatitis
- Myelitis
- Pneumococcal Infections
- Hepatitis B
- Pneumonia, Pneumococcal
- Diphtheria
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- 109507
- 2006-005733-38 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Study Data/Documents
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Study Protocol
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 109507Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.