NCT00307567|CompletedPhase 2

Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

A Phase II, Multicentre Booster Study to Evaluate Booster Vaccination With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following the Administration of a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 11PN-PD-DIT-002 (103488)

GlaxoSmithKline ClinicalTrials.gov

Compare

1 other identifier

105555

Study Type

interventional

Target

689

Locations

1 country

Sites

Timeline

RegisteredMar 2006

StartedNov 2005

CompletionMar 2006

Brief Summary

Booster and immune memory study

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

689

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2005

Shorter than P25 for phase_2

Geographic Reach

1 country

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

November 1, 2005

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2006

Completed

21 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed

Last Updated

September 23, 2016

Status Verified

September 1, 2016

First QC Date

March 7, 2006

Last Update Submit

September 22, 2016

Conditions

Acellular Pertussis Tetanus Hepatitis B Diphtheria Haemophilus Influenzae Type b Poliomyelitis

Outcome Measures

Primary Outcomes (1)

1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,

Secondary Outcomes (6)

Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Ab concentrations to protein D & seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Occurrence of: solicited local*,general *symptoms within 4 d
+1 more secondary outcomes

Interventions

Pneumococcal (vaccine)BIOLOGICAL

Eligibility Criteria

Age11 Months - 18 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

GlaxoSmithKlinelead

Study Sites (51)

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, 88348, Germany

Location

GSK Investigational Site

Bretten, Baden-Wurttemberg, 75015, Germany

Location

GSK Investigational Site

Eppelheim, Baden-Wurttemberg, 69214, Germany

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, 77704, Germany

Location

GSK Investigational Site

Offenburg, Baden-Wurttemberg, 77654, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, 97941, Germany

Location

GSK Investigational Site

Cham, Bavaria, 93413, Germany

Location

GSK Investigational Site

Herzogenaurach, Bavaria, 91074, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80939, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81241, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81675, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Weilheim, Bavaria, 82362, Germany

Location

GSK Investigational Site

Koenigstein, Hesse, 61462, Germany

Location

GSK Investigational Site

Wiesbaden, Hesse, 65205, Germany

Location

GSK Investigational Site

Salzgitter, Lower Saxony, 38226, Germany

Location

GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

Location

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, 18059, Germany

Location

GSK Investigational Site

Waren, Mecklenburg-Vorpommern, 17192, Germany

Location

GSK Investigational Site

Detmold, North Rhine-Westphalia, 32756, Germany

Location

GSK Investigational Site

Dortmund, North Rhine-Westphalia, 44329, Germany

Location

GSK Investigational Site

Erkrath, North Rhine-Westphalia, 40699, Germany

Location

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, 42579, Germany

Location

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, 47533, Germany

Location

GSK Investigational Site

Krefeld, North Rhine-Westphalia, 47798, Germany

Location

GSK Investigational Site

Löhne, North Rhine-Westphalia, 32584, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48159, Germany

Location

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, 55294, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, 67059, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54294, Germany

Location

GSK Investigational Site

Worms, Rhineland-Palatinate, 67547, Germany

Location

GSK Investigational Site

Bredstedt, Schleswig-Holstein, 25821, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24939, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24943, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24944, Germany

Location

GSK Investigational Site

Husum, Schleswig-Holstein, 25813, Germany

Location

GSK Investigational Site

Neumünster, Schleswig-Holstein, 24534, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 12627, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13355, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

MeSH Terms

Conditions

TetanusHepatitis BDiphtheriaHaemophilus InfectionsPoliomyelitis

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesCorynebacterium InfectionsActinomycetales InfectionsPasteurellaceae InfectionsGram-Negative Bacterial InfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

GSK Clinical Trials
GlaxoSmithKline
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 28, 2006

Study Start

November 1, 2005

Study Completion

March 1, 2006

Last Updated

September 23, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing: Will share

Locations

DE(51)

Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (51)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (51)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations