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

NCT ID: NCT00463437

Last Updated: 2020-01-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-25

Study Completion Date

2008-06-14

Brief Summary

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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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Detailed Description

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

Conditions

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Hepatitis B Acellular Pertussis Tetanus Poliomyelitis Diphtheria Streptococcus Pneumoniae Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

Infanrix hexa

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV Hib

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Meningitec

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

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.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

Infanrix hexa

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV Hib

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

NeisVac-C

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

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.

Group Type EXPERIMENTAL

Pneumococcal conjugate vaccine GSK1024850A

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

Infanrix penta

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Menitorix

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

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.

Group Type ACTIVE_COMPARATOR

Prevenar

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

Infanrix penta

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Menitorix

Intervention Type BIOLOGICAL

Intramuscular injection, 1 dose.

Interventions

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Pneumococcal conjugate vaccine GSK1024850A

Intramuscular injection, 1 dose.

Intervention Type BIOLOGICAL

Prevenar

Intramuscular injection, 1 dose.

Intervention Type BIOLOGICAL

Infanrix hexa

Intramuscular injection, 1 dose. In Germany and Poland.

Intervention Type BIOLOGICAL

Infanrix IPV Hib

Intramuscular injection, 1 dose. In Spain.

Intervention Type BIOLOGICAL

Infanrix penta

Intramuscular injection, 1 dose. In Germany and Poland.

Intervention Type BIOLOGICAL

Infanrix IPV

Intramuscular injection, 1 dose. In Spain.

Intervention Type BIOLOGICAL

Meningitec

Intramuscular injection, 1 dose.

Intervention Type BIOLOGICAL

NeisVac-C

Intramuscular injection, 1 dose.

Intervention Type BIOLOGICAL

Menitorix

Intramuscular injection, 1 dose.

Intervention Type BIOLOGICAL

Other Intervention Names

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Pneumococcal conjugate vaccine (Wyeth Lederle). DTPa-HBV-IPV/Hib (GSK Biologicals). DTPa-IPV/Hib (GSK Biologicals). DTPa-HBV-IPV (GSK Biologicals). DTPa-IPV (GSK Biologicals) Meningococcal C conjugate vaccine (Wyeth). Meningococcal C conjugate vaccine (Baxter). Combined Hib-MenC vaccine (GSK Biologicals).

Eligibility Criteria

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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).
Minimum Eligible Age

11 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Tettnang, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Cham, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Nördlingen, Bavaria, Germany

Site Status

GSK Investigational Site

Olching, Bavaria, Germany

Site Status

GSK Investigational Site

Roding, Bavaria, Germany

Site Status

GSK Investigational Site

Eschwege, Hesse, Germany

Site Status

GSK Investigational Site

Niedernhausen, Hesse, Germany

Site Status

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

Site Status

GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Döbeln, Saxony, Germany

Site Status

GSK Investigational Site

Singwitz, Saxony, Germany

Site Status

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

Site Status

GSK Investigational Site

Weimar, Thuringia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Dębica, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Siemianowice Śląskie, , Poland

Site Status

GSK Investigational Site

Tarnów, , Poland

Site Status

GSK Investigational Site

Wola, , Poland

Site Status

GSK Investigational Site

Bilbao, , Spain

Site Status

GSK Investigational Site

Blanes (Girona), , Spain

Site Status

GSK Investigational Site

Burgos, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Marid, , Spain

Site Status

GSK Investigational Site

Málaga, , Spain

Site Status

GSK Investigational Site

Montgat/Barcelona, , Spain

Site Status

GSK Investigational Site

Móstoles/Madrid, , Spain

Site Status

GSK Investigational Site

Sant Vicenç Dels Horts /Barcelona, , Spain

Site Status

GSK Investigational Site

Tona/Barcelona, , Spain

Site Status

GSK Investigational Site

Valladolid, , Spain

Site Status

GSK Investigational Site

Vélez-Málaga / Málaga, , Spain

Site Status

Countries

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Germany Poland Spain

References

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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.

Reference Type BACKGROUND
PMID: 19325447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19325452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19325450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26954689 (View on PubMed)

Study Documents

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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2006-005733-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109507

Identifier Type: -

Identifier Source: org_study_id

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