MedDataX Logo

Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule

NCT ID: NCT00513409

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-22

Study Completion Date

2008-08-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections, Streptococcal

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Immunogenicity Pneumococcal disease Safety Booster vaccination Pneumococcal vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Synflorix Booster Group

Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Group Type EXPERIMENTAL

Synflorix

Intervention Type BIOLOGICAL

Intramuscular injection, 1 or 2 doses

Infanrix Hexa

Intervention Type BIOLOGICAL

1 Intramuscular injection

Havrix

Intervention Type BIOLOGICAL

1 Intramuscular injection

Synflorix Catch-up Group

Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).

Group Type EXPERIMENTAL

Synflorix

Intervention Type BIOLOGICAL

Intramuscular injection, 1 or 2 doses

Infanrix Hexa

Intervention Type BIOLOGICAL

1 Intramuscular injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Synflorix

Intramuscular injection, 1 or 2 doses

Intervention Type BIOLOGICAL

Infanrix Hexa

1 Intramuscular injection

Intervention Type BIOLOGICAL

Havrix

1 Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DTPa-HBV-IPV/Hib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female between, and including, 18-21 months of age at the time of vaccination.
* Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
* 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.

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
* Acute disease at the time of enrolment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
* 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 the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.
Minimum Eligible Age

18 Months

Maximum Eligible Age

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Chile

References

Explore related publications, articles, or registry entries linked to this study.

Lagos RE, Munoz AE, Levine MM, Lepetic A, Francois 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. doi: 10.4161/hv.7.5.14634. Epub 2011 May 1.

Reference Type BACKGROUND
PMID: 21441782 (View on PubMed)

Lagos R et al. 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) given as booster dose or 2-dose catch-up in Chilean children. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.

Reference Type BACKGROUND

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

110031

Identifier Type: -

Identifier Source: org_study_id