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Hepatitis BPhase 3NCT00463437

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

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Prevenar and Infanrix hexa in people with Hepatitis B and Acellular Pertussis, run by GlaxoSmithKline at 63 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 11 to 18 monthsHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Acellular Pertussis, Tetanus
What is being tested?
Pneumococcal conjugate vaccine GSK1024850A, Prevenar and Infanrix hexa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,437 participants
Where
63 sitesin 3 countries
Study dates
25 Apr 2007to 14 Jun 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

63 sites in 3 countries.

63 sites in 3 countries

Germany42 sites

  • GSK Investigational Site

    Bad Kreuznach, Rhineland-Palatinate, 55543

  • GSK Investigational Site

    Bad Lobenstein, Thuringia, 07356

  • GSK Investigational Site

    Bad Saulgau, Baden-Wurttemberg, 88348

  • GSK Investigational Site

    Berlin, 10315

  • GSK Investigational Site

    Berlin, 10967

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 12679

  • GSK Investigational Site

    Berlin, 13355

  • GSK Investigational Site

    Berlin, 14197

  • GSK Investigational Site

    Bodenheim, Rhineland-Palatinate, 55294

  • GSK Investigational Site

    Bönnigheim, Baden-Wurttemberg, 74357

  • GSK Investigational Site

    Bretten, Baden-Wurttemberg, 75015

  • GSK Investigational Site

    Cham, Bavaria, 93413

  • GSK Investigational Site

    Döbeln, Saxony, 04720

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Ettenheim, Baden-Wurttemberg, 77955

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Gerolstein, Rhineland-Palatinate, 54568

  • GSK Investigational Site

    Hille, North Rhine-Westphalia, 32479

  • GSK Investigational Site

    Karlsruhe, Baden-Wurttemberg, 76189

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Löhne, North Rhine-Westphalia, 32584

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Munich, Bavaria, 81675

  • GSK Investigational Site

    Munich, Bavaria, 81735

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48163

  • GSK Investigational Site

    Niedernhausen, Hesse, 65527

  • GSK Investigational Site

    Nördlingen, Bavaria, 86720

  • GSK Investigational Site

    Oberstenfeld, Baden-Wurttemberg, 71720

  • GSK Investigational Site

    Olching, Bavaria, 82140

  • GSK Investigational Site

    Porta Westfalica, North Rhine-Westphalia, 32457

  • GSK Investigational Site

    Roding, Bavaria, 93426

  • GSK Investigational Site

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • GSK Investigational Site

    Singwitz, Saxony, 02692

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70469

  • GSK Investigational Site

    Tettnang, Baden-Wurttemberg, 88069

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54294

  • GSK Investigational Site

    Weimar, Thuringia, 99425

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38302

  • GSK Investigational Site

    Worms, Rhineland-Palatinate, 67547

Other trials in Germany

Spain14 sites

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Blanes (Girona), 17300

  • GSK Investigational Site

    Burgos, 09005

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Málaga, 29011

  • GSK Investigational Site

    Marid, 28040

  • GSK Investigational Site

    Montgat/Barcelona, 08390

  • GSK Investigational Site

    Móstoles/Madrid, 28935

  • GSK Investigational Site

    Sant Vicenç Dels Horts /Barcelona, 08620

  • GSK Investigational Site

    Tona/Barcelona, 08551

  • GSK Investigational Site

    Valladolid, 47010

  • GSK Investigational Site

    Vélez-Málaga / Málaga, 29700

Other trials in Spain

Poland7 sites

  • GSK Investigational Site

    Bydgoszcz, 85-021

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Krakow

  • GSK Investigational Site

    Poznan, 61-709

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Wola, 43-225

Other trials in Poland

About this study

Official title: 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).

Read the detailed description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Being tested
Pneumococcal conjugate vaccine GSK1024850A, Prevenar, Infanrix hexa, Infanrix IPV Hib, Infanrix penta
Keywords
Fever., Meningococcal disease., Pneumococcal disease., Meningococcal vaccine., Pneumococcal vaccine., Immunogenicity., Booster vaccination., Safety.
Medical subject headings
Hepatitis B, Tetanus, Poliomyelitis, Diphtheria, Fever, Meningococcal Infections, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal conjugate vaccine GSK1024850ABiological

    Intramuscular injection, 1 dose.

  • PrevenarBiological

    Also called Pneumococcal conjugate vaccine (Wyeth Lederle).

    Intramuscular injection, 1 dose.

  • Infanrix hexaBiological

    Also called DTPa-HBV-IPV/Hib (GSK Biologicals).

    Intramuscular injection, 1 dose. In Germany and Poland.

  • Infanrix IPV HibBiological

    Also called DTPa-IPV/Hib (GSK Biologicals).

    Intramuscular injection, 1 dose. In Spain.

  • Infanrix pentaBiological

    Also called DTPa-HBV-IPV (GSK Biologicals).

    Intramuscular injection, 1 dose. In Germany and Poland.

  • Infanrix IPVBiological

    Also called DTPa-IPV (GSK Biologicals)

    Intramuscular injection, 1 dose. In Spain.

  • MeningitecBiological

    Also called Meningococcal C conjugate vaccine (Wyeth).

    Intramuscular injection, 1 dose.

  • NeisVac-CBiological

    Also called Meningococcal C conjugate vaccine (Baxter).

    Intramuscular injection, 1 dose.

  • MenitorixBiological

    Also called Combined Hib-MenC vaccine (GSK Biologicals).

    Intramuscular injection, 1 dose.

Study groups in NCT00463437
Study groupRoleWhat they receive
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ExperimentalSubjects 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.
Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa; Biological: Infanrix IPV Hib; Biological: Meningitec
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ExperimentalSubjects 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.
Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa; Biological: Infanrix IPV Hib; Biological: NeisVac-C
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ExperimentalSubjects 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.
Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix penta; Biological: Infanrix IPV; Biological: Menitorix
Prevenar™ + Menitorix™Active comparatorSubjects 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.
Receives: Biological: Prevenar; Biological: Infanrix penta; Biological: Infanrix IPV; Biological: Menitorix

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Fever was measured as rectal temperature.

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

Secondary outcomes (13)

  1. Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling.

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

  2. Number of Subjects Reporting Solicited General Symptoms

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

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2007 (estimated)
  2. Study start25 Apr 2007
  3. Primary completion21 Jan 2008
  4. Study completion14 Jun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463437
Sponsor's protocol ID
109507
Other IDs
2006-005733-38
Status last verified
Dec 2019
First submitted
19 Apr 2007
Last updated
2 Jan 2020
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

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.

    PubMed 19325447

  • 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.

    PubMed 19325452

  • 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.

    PubMed 19325450

  • 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.

    PubMed 26954689

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Prevenar and Infanrix hexa in people with Hepatitis B and Acellular Pertussis, run by GlaxoSmithKline at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Germany, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463437, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.

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