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

Purpose

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).

Condition	Intervention	Phase
Pneumococcal Disease. Meningococcal Disease. Streptococcus Pneumoniae Vaccines	Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Prevenar Biological: Infanrix hexa Biological: Infanrix IPV Hib Biological: Infanrix penta Biological: Infanrix IPV Biological: Meningitec Biological: NeisVac-C Biological: Menitorix	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

Resource links provided by NLM:

MedlinePlus related topics: Fever Meningococcal Infections Pneumonia

Drug Information available for: Boostrix Heptavalent pneumococcal conjugate vaccine Adacel Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C) [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
Fever was measured as rectal temperature.

Secondary Outcome Measures:

Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
Solicited local symptoms assessed include pain, redness and swelling.
Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) period after the booster vaccination ] [ Designated as safety issue: No ]
Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 31-day (Day 0-30) period after the booster vaccination ] [ Designated as safety issue: No ]
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 Reporting Serious Adverse Events (SAE) [ Time Frame: During the 31-day (Day 0-30) period after the booster vaccination ] [ Designated as safety issue: No ]
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 Reporting Serious Adverse Events (SAE) [ Time Frame: From the beginning of the study up to the end of the extended 6-month safety follow-up period ] [ Designated as safety issue: No ]
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 Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
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 Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
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 Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
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 Cross-reactive Pneumococcal Serotypes Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
Anti-pneumococcal antibody cut-off value assessed was ≥ 8.

The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
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 [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
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 [ Time Frame: Before (pre) and one month after (post) the booster administration ] [ Designated as safety issue: No ]
Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.

Enrollment:	1437
Study Start Date:	April 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 1 dose. Biological: Infanrix hexa Intramuscular injection, 1 dose. In Germany and Poland. Other Name: DTPa-HBV-IPV/Hib (GSK Biologicals). Biological: Infanrix IPV Hib Intramuscular injection, 1 dose. In Spain. Other Name: DTPa-IPV/Hib (GSK Biologicals). Biological: Meningitec Intramuscular injection, 1 dose. Other Name: Meningococcal C conjugate vaccine (Wyeth).
Experimental: 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.	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 1 dose. Biological: Infanrix hexa Intramuscular injection, 1 dose. In Germany and Poland. Other Name: DTPa-HBV-IPV/Hib (GSK Biologicals). Biological: Infanrix IPV Hib Intramuscular injection, 1 dose. In Spain. Other Name: DTPa-IPV/Hib (GSK Biologicals). Biological: NeisVac-C Intramuscular injection, 1 dose. Other Name: Meningococcal C conjugate vaccine (Baxter).
Experimental: 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.	Biological: Pneumococcal conjugate vaccine GSK1024850A Intramuscular injection, 1 dose. Biological: Infanrix penta Intramuscular injection, 1 dose. In Germany and Poland. Other Name: DTPa-HBV-IPV (GSK Biologicals). Biological: Infanrix IPV Intramuscular injection, 1 dose. In Spain. Other Name: DTPa-IPV (GSK Biologicals) Biological: Menitorix Intramuscular injection, 1 dose. Other Name: Combined Hib-MenC vaccine (GSK Biologicals).
Active Comparator: 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.	Biological: Prevenar Intramuscular injection, 1 dose. Other Name: Pneumococcal conjugate vaccine (Wyeth Lederle). Biological: Infanrix penta Intramuscular injection, 1 dose. In Germany and Poland. Other Name: DTPa-HBV-IPV (GSK Biologicals). Biological: Infanrix IPV Intramuscular injection, 1 dose. In Spain. Other Name: DTPa-IPV (GSK Biologicals) Biological: Menitorix Intramuscular injection, 1 dose. Other Name: Combined Hib-MenC vaccine (GSK Biologicals).

Detailed Description:

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

Eligibility

Ages Eligible for Study:	11 Months to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463437

Show 62 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

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.

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.

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.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00463437 History of Changes
Other Study ID Numbers:	109507
Study First Received:	April 19, 2007
Results First Received:	June 11, 2009
Last Updated:	August 2, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

Fever.
Meningococcal disease.
Pneumococcal disease.
Meningococcal vaccine.

Pneumococcal vaccine.
Immunogenicity.
Booster vaccination.
Safety.

Additional relevant MeSH terms:

Meningococcal Infections
Pneumonia
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pentetic Acid
PENTA
Chelating Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Anticoagulants
Hematologic Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013