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

NCT00463437 | Completed Phase 3 Results

• 2 other identifiers: 1095072006-005733-38
• Study Type: interventional
• Target: 1,437
• Locations: 3 countries
• Sites: 63

Brief 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 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).

Conditions

Hepatitis B; Acellular Pertussis; Tetanus; Poliomyelitis; Diphtheria; Streptococcus Pneumoniae Vaccines

Keywords

Fever.; Meningococcal disease.; Pneumococcal disease.; Meningococcal vaccine.; Pneumococcal vaccine.; Immunogenicity.; Booster vaccination.; Safety.

Outcome Measures

Primary Outcomes (1)

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

  Fever was measured as rectal temperature.

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

Secondary Outcomes (13)

• Number of Subjects Reporting Solicited Local Symptoms

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

• Number of Subjects Reporting Solicited General Symptoms

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

• Number of Subjects Reporting Unsolicited Adverse Events (AE)

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

• Number of Subjects Reporting Serious Adverse Events (SAE)

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

• Number of Subjects Reporting Serious Adverse Events (SAE)

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

Study Arms (4)

GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™

EXPERIMENTAL

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.

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa; Biological: Infanrix IPV Hib; Biological: Meningitec

GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™

EXPERIMENTAL

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.

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix hexa; Biological: Infanrix IPV Hib; Biological: NeisVac-C

GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™

EXPERIMENTAL

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.

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Infanrix penta; Biological: Infanrix IPV; Biological: Menitorix

Prevenar™ + Menitorix™

ACTIVE COMPARATOR

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.

Biological: Prevenar; Biological: Infanrix penta; Biological: Infanrix IPV; Biological: Menitorix

Interventions

Pneumococcal conjugate vaccine GSK1024850A BIOLOGICAL

Intramuscular injection, 1 dose.

GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™; GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™; GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™

Prevenar BIOLOGICAL

Intramuscular injection, 1 dose.

Also known as: Pneumococcal conjugate vaccine (Wyeth Lederle).

Prevenar™ + Menitorix™

Infanrix hexa BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Also known as: DTPa-HBV-IPV/Hib (GSK Biologicals).

GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™; GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™

Infanrix IPV Hib BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Also known as: DTPa-IPV/Hib (GSK Biologicals).

GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™; GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™

Infanrix penta BIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Also known as: DTPa-HBV-IPV (GSK Biologicals).

GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™; Prevenar™ + Menitorix™

Infanrix IPV BIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Also known as: DTPa-IPV (GSK Biologicals)

GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™; Prevenar™ + Menitorix™

Meningitec BIOLOGICAL

Intramuscular injection, 1 dose.

Also known as: Meningococcal C conjugate vaccine (Wyeth).

GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™

NeisVac-C BIOLOGICAL

Intramuscular injection, 1 dose.

Also known as: Meningococcal C conjugate vaccine (Baxter).

GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™

Menitorix BIOLOGICAL

Intramuscular injection, 1 dose.

Also known as: Combined Hib-MenC vaccine (GSK Biologicals).

GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™; Prevenar™ + Menitorix™

Eligibility Criteria

• Age: 11 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (63)

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, 88348, Germany

Location

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, 74357, Germany

Location

GSK Investigational Site

Bretten, Baden-Wurttemberg, 75015, Germany

Location

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, 77955, Germany

Location

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, 76189, Germany

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, 71720, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, 70469, Germany

Location

GSK Investigational Site

Tettnang, Baden-Wurttemberg, 88069, Germany

Location

GSK Investigational Site

Cham, Bavaria, 93413, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81675, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81735, Germany

Location

GSK Investigational Site

Nördlingen, Bavaria, 86720, Germany

Location

GSK Investigational Site

Olching, Bavaria, 82140, Germany

Location

GSK Investigational Site

Roding, Bavaria, 93426, Germany

Location

GSK Investigational Site

Eschwege, Hesse, 37269, Germany

Location

GSK Investigational Site

Niedernhausen, Hesse, 65527, Germany

Location

GSK Investigational Site

Wolfenbüttel, Lower Saxony, 38302, Germany

Location

GSK Investigational Site

Hille, North Rhine-Westphalia, 32479, Germany

Location

GSK Investigational Site

Löhne, North Rhine-Westphalia, 32584, Germany

Location

GSK Investigational Site

Münster, North Rhine-Westphalia, 48163, Germany

Location

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, 32457, Germany

Location

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, 55543, Germany

Location

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, 55294, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, 54568, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, 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

Döbeln, Saxony, 04720, Germany

Location

GSK Investigational Site

Singwitz, Saxony, 02692, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Berlin, 10315, Germany

Location

GSK Investigational Site

Berlin, 10967, Germany

Location

GSK Investigational Site

Berlin, 12627, Germany

Location

GSK Investigational Site

Berlin, 12679, Germany

Location

GSK Investigational Site

Berlin, 13355, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

GSK Investigational Site

Bydgoszcz, 85-021, Poland

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, Poland

Location

GSK Investigational Site

Poznan, 61-709, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Tarnów, 33-100, Poland

Location

GSK Investigational Site

Wola, 43-225, Poland

Location

GSK Investigational Site

Bilbao, 48013, Spain

Location

GSK Investigational Site

Blanes (Girona), 17300, Spain

Location

GSK Investigational Site

Burgos, 09005, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28035, Spain

Location

GSK Investigational Site

Madrid, 28047, Spain

Location

GSK Investigational Site

Marid, 28040, Spain

Location

GSK Investigational Site

Málaga, 29011, Spain

Location

GSK Investigational Site

Montgat/Barcelona, 08390, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

GSK Investigational Site

Sant Vicenç Dels Horts /Barcelona, 08620, Spain

Location

GSK Investigational Site

Tona/Barcelona, 08551, Spain

Location

GSK Investigational Site

Valladolid, 47010, Spain

Location

GSK Investigational Site

Vélez-Málaga / Málaga, 29700, Spain

Location

Related Publications (4)

• 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.

  PMID: 19325447 BACKGROUND

• 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.

  PMID: 19325452 BACKGROUND

• 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.

  PMID: 19325450 BACKGROUND

• 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.

  PMID: 26954689 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Fever; Meningococcal Infections; Pneumococcal Infections

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; serogroup C meningococcal conjugate vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Corynebacterium Infections; Actinomycetales Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Streptococcal Infections

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 20, 2007
• Study Start: April 25, 2007
• Primary Completion: January 21, 2008
• Study Completion: June 14, 2008
• Last Updated: January 2, 2020
• Results First Posted: August 3, 2009

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.

Locations

PL (7); ES (14); DE (42)