Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Infections, Streptococcal Clinical Trial

Official title:

Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307541
• Other study ID #: 105554
• Secondary ID: 2005-003299-40
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2005
• Est. completion date: April 7, 2006

Study information

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

Clinical Trial Summary

Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Description:

Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 7, 2006
• Est. primary completion date: April 7, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Weeks to 16 Weeks

Eligibility

Inclusion criteria:

• Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion criteria:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Related Conditions & MeSH terms

• Infections, Streptococcal
• Pneumonia
• Streptococcal Infections
• Streptococcus Pneumoniae Vaccines

Intervention

Biological:
• Pneumococcal (vaccine)

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Oeynhausen	Nordrhein-Westfalen
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	Erkrath	Nordrhein-Westfalen
Germany	GSK Investigational Site	Frankenthal	Rheinland-Pfalz
Germany	GSK Investigational Site	Gerolstein	Rheinland-Pfalz
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Heiligenhaus	Nordrhein-Westfalen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Lobenstein	Thueringen
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Marbach	Baden-Wuerttemberg
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Moenchengladbach	Nordrhein-Westfalen
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Neuhaus am Rennweg	Thueringen
Germany	GSK Investigational Site	Noerdlingen	Bayern
Germany	GSK Investigational Site	Oberhausen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Stollberg	Sachsen
Germany	GSK Investigational Site	Trier	Rheinland-Pfalz
Germany	GSK Investigational Site	Tutzing	Bayern
Germany	GSK Investigational Site	Waren	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Weimar	Thueringen
Germany	GSK Investigational Site	Wiesbaden	Hessen
Germany	GSK Investigational Site	Willich	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Köllges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
Secondary	1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Secondary	Antibody (Ab) concns >= 0.05 µg/mL
Secondary	Ab concns to protein D and seropositivity (S+) status
Secondary	S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Secondary	After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Secondary	Unsolicited adverse events within 31 days, SAEs (whole study period)

External Links

•   Booster Study