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

NCT ID: NCT00345358

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-18
• Study Completion Date: 2007-11-15

Brief Summary

The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:

< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.

Detailed Description

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

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Synflorix <6M Group

This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Group Type: ACTIVE_COMPARATOR

Synflorix

Intervention Type: BIOLOGICAL

1, 2, 3 or 4 Intramuscular injections, depending on age group

Infanrix IPV/Hib

Intervention Type: BIOLOGICAL

4 intramuscular injections

Synflorix 7-11M Group

This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Group Type: EXPERIMENTAL

Synflorix

Intervention Type: BIOLOGICAL

1, 2, 3 or 4 Intramuscular injections, depending on age group

Synflorix 12-23M Group

This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Group Type: EXPERIMENTAL

Synflorix

Intervention Type: BIOLOGICAL

1, 2, 3 or 4 Intramuscular injections, depending on age group

Synflorix >=24M Group

This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate).

Group Type: EXPERIMENTAL

Synflorix

Intervention Type: BIOLOGICAL

1, 2, 3 or 4 Intramuscular injections, depending on age group

Interventions

Synflorix

1, 2, 3 or 4 Intramuscular injections, depending on age group

Intervention Type: BIOLOGICAL

Infanrix IPV/Hib

4 intramuscular injections

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal conjugate vaccine GSK1024850A.; DTPa-IPV/Hib

Eligibility Criteria

Inclusion Criteria

• Male or female between, and including

• 9-12 weeks of age at the time of first vaccination for the <6 Mo group.
• 7-11 months of age at the time of first vaccination for the 7-11 Mo group.
• 12-23 months of age at the time of first vaccination for the 12-23 Mo group.
• 24 months to 5 years at the time of first vaccination for the >= 24 Mo group.
• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
• 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.
• Born after a gestation period between 36 and 42 weeks.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
• Previous vaccination against S. pneumoniae.
• 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 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 since birth or planned administration during the entire study period.

• Minimum Eligible Age: 9 Weeks
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Espoo, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Helsinki, , Finland

GSK Investigational Site

Järvenpää, , Finland

GSK Investigational Site

Kotka, , Finland

GSK Investigational Site

Lahti, , Finland

GSK Investigational Site

Seinäjoki, , Finland

GSK Investigational Site

Tampere, , Finland

GSK Investigational Site

Vantaa, , Finland

GSK Investigational Site

Vantaa, , Finland

Countries

Finland

References

Vesikari T, Karvonen A, Korhonen T, Karppa T, Sadeharju K, Fanic A, Dieussaert I, Schuerman L. Immunogenicity of 10-valent pneumococcal nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine when administered as catch-up vaccination to children 7 months to 5 years of age. Pediatr Infect Dis J. 2011 Aug;30(8):e130-41. doi: 10.1097/INF.0b013e31821d1790.

Reference Type: BACKGROUND

PMID: 21540760 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

107058

Identifier Type: -

Identifier Source: org_study_id