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

Phase 3

Completed

• Conditions: Acellular Pertussis; Streptococcus Pneumoniae Vaccines; Tetanus; Poliomyelitis; Diphtheria; Hepatitis B
• Interventions: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Prevenar; Biological: Infanrix penta; Biological: Infanrix hexa; Biological: Infanrix IPV Hib; Biological: Infanrix IPV; Biological: Meningitec; Biological: NeisVac-C; Biological: Menitorix

• Registration Number: NCT00463437
• Lead Sponsor: GlaxoSmithKline

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).

Detailed Description

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

Study Timeline

• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Study Start: 2007-04-25
• Primary Completion: 2008-01-21
• Study Completion: 2008-06-14
• Results First Submitted: 2009-06-11
• Results First Submitted QC: 2009-06-11
• Results First Posted: 2009-08-03
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1437

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Pneumococcal conjugate vaccine GSK1024850A	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Infanrix penta	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Pneumococcal conjugate vaccine GSK1024850A	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Pneumococcal conjugate vaccine GSK1024850A	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Infanrix IPV Hib	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	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.
Prevenar™ + Menitorix™	Infanrix penta	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Infanrix hexa	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™	Infanrix IPV Hib	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™	Infanrix hexa	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.
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™	Infanrix IPV	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.
Prevenar™ + Menitorix™	Prevenar	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.
Prevenar™ + Menitorix™	Infanrix IPV	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.
Prevenar™ + Menitorix™	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)	During the 4-day (Day 0-3) period after the booster vaccination	Fever was measured as rectal temperature.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Solicited Local Symptoms	During the 4-day (Day 0-3) period after the booster vaccination	Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects Reporting Solicited General Symptoms	During the 4-day (Day 0-3) period after the booster vaccination	Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
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	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.
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	Anti-pneumococcal antibody cut-off value assessed was ≥ 8.; The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Number of Subjects Reporting Unsolicited Adverse Events (AE)	During the 31-day (Day 0-30) period after the booster vaccination	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.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.
Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	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.
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	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.
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	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.
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value	Before (pre) and one month after (post) the booster administration	Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Vélez-Málaga / Málaga, Spain