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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00463437
Other study ID # 109507
Secondary ID 2006-005733-38
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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