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

Hepatitis B Clinical Trial

Official title:

Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463437
• Other study ID #: 109507
• Secondary ID: 2006-005733-38
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2007
• Est. completion date: June 14, 2008

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1437
• Est. completion date: June 14, 2008
• Est. primary completion date: January 21, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Months to 18 Months

Eligibility

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).

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Hepatitis B
• Pneumonia
• Poliomyelitis
• Streptococcus Pneumoniae Vaccines
• Tetanus

Intervention

Biological:
• Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 1 dose.
• Prevenar
Intramuscular injection, 1 dose.
• Infanrix hexa
Intramuscular injection, 1 dose. In Germany and Poland.
• Infanrix IPV Hib
Intramuscular injection, 1 dose. In Spain.
• Infanrix penta
Intramuscular injection, 1 dose. In Germany and Poland.
• Infanrix IPV
Intramuscular injection, 1 dose. In Spain.
• Meningitec
Intramuscular injection, 1 dose.
• NeisVac-C
Intramuscular injection, 1 dose.
• Menitorix
Intramuscular injection, 1 dose.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Kreuznach	Rheinland-Pfalz
Germany	GSK Investigational Site	Bad Saulgau	Baden-Wuerttemberg
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bodenheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Boennigheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Bretten	Baden-Wuerttemberg
Germany	GSK Investigational Site	Cham	Bayern
Germany	GSK Investigational Site	Doebeln	Sachsen
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Ettenheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Gerolstein	Rheinland-Pfalz
Germany	GSK Investigational Site	Hille	Nordrhein-Westfalen
Germany	GSK Investigational Site	Karlsruhe	Baden-Wuerttemberg
Germany	GSK Investigational Site	Kehl	Baden-Wuerttemberg
Germany	GSK Investigational Site	Lobenstein	Thueringen
Germany	GSK Investigational Site	Loehne	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Niedernhausen	Hessen
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Oberstenfeld	Baden-Wuerttemberg
Germany	GSK Investigational Site	Olching	Bayern
Germany	GSK Investigational Site	Porta Westfalica	Nordrhein-Westfalen
Germany	GSK Investigational Site	Roding	Bayern
Germany	GSK Investigational Site	Schwaebisch-Hall	Baden-Wuerttemberg
Germany	GSK Investigational Site	Singwitz	Sachsen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tettnang	Baden-Wuerttemberg
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Wolfenbuettel	Niedersachsen
Germany	GSK Investigational Site	Worms	Rheinland-Pfalz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Tarnow
Poland	GSK Investigational Site	Wola
Spain	GSK Investigational Site	Bilbao
Spain	GSK Investigational Site	Blanes (Girona)
Spain	GSK Investigational Site	Burgos
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Málaga
Spain	GSK Investigational Site	Marid
Spain	GSK Investigational Site	Montgat/Barcelona
Spain	GSK Investigational Site	Móstoles/Madrid
Spain	GSK Investigational Site	Sant Vicenç Dels Horts /Barcelona
Spain	GSK Investigational Site	Tona/Barcelona
Spain	GSK Investigational Site	Valladolid
Spain	GSK Investigational Site	Vélez-Málaga / Málaga

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Poland,  Spain, 

References & 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. Review. — View Citation

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. Review. — View Citation

Silfverdal SA, Coremans V, François 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. Review. — View Citation

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. — View Citation

Outcome

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

External 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.