Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines

NCT00891176 | Completed Phase 3 Results

• 1 other identifier: 112830
• Study Type: interventional
• Target: 582
• Locations: 3 countries
• Sites: 28

Brief Summary

This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437). The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.

Conditions

Neisseria Meningitidis; Haemophilus Influenzae Type b

Keywords

Conjugate vaccines; Meningococcal serogroup C vaccine; Antibody persistence; Pneumococcal vaccine; Haemophilus Influenzae type b vaccine

Outcome Measures

Primary Outcomes (3)

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

  rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.

  At 3 years of age

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

  rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.

  At 6 years of age

• Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value

  rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.

  At 4 years of age

Secondary Outcomes (31)

• Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value

  At 3 years of age

• rSBA-MenC Titers

  At 3 years of age

• Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values

  At 3 years of age

• Anti-PRP Concentrations

  At 3 years of age

• Antibody Concentrations Against Vaccine Pneumococcal Serotypes

  At 3 years of age

Study Arms (4)

Synflorix-Meningitec Group

EXPERIMENTAL

Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: MeningitecTM; Biological: InfanrixTM hexa; Biological: InfanrixTM IPV/Hib

Synflorix-NeisVac-C Group

EXPERIMENTAL

Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.

Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: NeisVac-CTM; Biological: InfanrixTM hexa; Biological: InfanrixTM IPV/Hib

Synflorix-Menitorix Group

EXPERIMENTAL

Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.

Biological: MenitorixTM; Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: InfanrixTM penta; Biological: InfanrixTM IPV

Prevenar-Menitorix Group

ACTIVE COMPARATOR

Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.

Biological: MenitorixTM; Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: PrevenarTM; Biological: InfanrixTM penta; Biological: InfanrixTM IPV

Interventions

MenitorixTM BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

Prevenar-Menitorix Group; Synflorix-Menitorix Group

Pneumococcal conjugate vaccine GSK1024850A BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

Prevenar-Menitorix Group; Synflorix-Meningitec Group; Synflorix-Menitorix Group; Synflorix-NeisVac-C Group

PrevenarTM BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.

Prevenar-Menitorix Group

MeningitecTM BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study

Synflorix-Meningitec Group

NeisVac-CTM BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study

Synflorix-NeisVac-C Group

InfanrixTM hexa BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study

Synflorix-Meningitec Group; Synflorix-NeisVac-C Group

InfanrixTM penta BIOLOGICAL

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study

Prevenar-Menitorix Group; Synflorix-Menitorix Group

InfanrixTM IPV/Hib BIOLOGICAL

Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study

Synflorix-Meningitec Group; Synflorix-NeisVac-C Group

InfanrixTM IPV BIOLOGICAL

Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study

Prevenar-Menitorix Group; Synflorix-Menitorix Group

Eligibility Criteria

• Age: 36 Months - 76 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 should be enrolled in the study.
• A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of Visit 3.
• Written informed consent obtained from the parent or guardian of the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who previously participated in the primary and booster studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the booster study, of the blood sampling subset.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of the booster study
• History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of booster study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of booster study, based on medical history and physical examination (no laboratory testing required).
• Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (28)

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, 88348, 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, 68163, Germany

Location

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, 71720, Germany

Location

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

Location

GSK Investigational Site

Tettnang, Baden-Wurttemberg, 88069, 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

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

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Trier, Rhineland-Palatinate, 54290, Germany

Location

GSK Investigational Site

Döbeln, Saxony, 04720, Germany

Location

GSK Investigational Site

Bad Lobenstein, Thuringia, 07356, Germany

Location

GSK Investigational Site

Weimar, Thuringia, 99425, Germany

Location

GSK Investigational Site

Berlin, 13355, Germany

Location

GSK Investigational Site

Berlin, 14197, Germany

Location

GSK Investigational Site

Dębica, 39-200, Poland

Location

GSK Investigational Site

Krakow, Poland

Location

GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Móstoles/Madrid, 28935, Spain

Location

Related Publications (1)

• Tejedor JC, Brzostek J, Konior R, Grunert D, Kolhe D, Baine Y, Van Der Wielen M. Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines. Clin Vaccine Immunol. 2016 Jul 5;23(7):555-63. doi: 10.1128/CVI.00057-16. Print 2016 Jul.

  PMID: 27145999 DERIVED

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

Haemophilus Infections

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody when tested by ELISA.The tables show both the results obtained by ELISA and updated results following complete retesting by CLIA.

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 30, 2009
• First Posted: May 1, 2009
• Study Start: May 14, 2009
• Primary Completion: November 21, 2012
• Study Completion: November 21, 2012
• Last Updated: February 15, 2018
• Results First Posted: December 23, 2010

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (23); PL (3); ES (2)