Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00338351

Collaborator

(none)

240

Enrollment

Location

Duration (Months)

39.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A	Biological: Pneumococcal (vaccine)	Phase 2

Detailed Description

Test groups: 2 (120 subjects/group). 1 group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa combined vaccine; Control group receiving GSK Biologicals' Havrix + DTPa combined vaccine

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Prevention

Official Title:

To Assess Reactogenicity and Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Co-administered With GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix™ Hexa) at 2, 4 and 6 Months of Age.

Study Start Date :

Apr 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

After each dose: Grade 3 AEs []

Secondary Outcome Measures

After each dose: solicited/unsolicited AEs (4/31 days),SAEs (whole study); 1 month post 3: antibody concns to vaccine antigens []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Weeks to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female between, and including, 6 and 12 weeks (42-90 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Santiago	Región Metro De Santiago	Chile

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

Lagos RE, Muñoz AE, Levine MM, Lepetic A, François N, Yarzabal JP, Schuerman L. Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children. Hum Vaccin. 2011 May;7(5):511-22. Epub 2011 May 1.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00338351

Other Study ID Numbers:

106208

First Posted:

Jun 20, 2006

Last Update Posted:

Sep 28, 2016

Last Verified:

Sep 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Hepatitis A

Study Results

No Results Posted as of Sep 28, 2016