Clinical trial NCT00513409: Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
Official title: Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Streptococcal
Keywords: Immunogenicity
Pneumococcal disease
Safety
Booster vaccination
Pneumococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
timeFrame: Within 4 days after the administration of any study vaccine dose
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: Within 4 days after the administration of any study vaccine dose
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: Within 4 days after the administration of any study vaccine dose
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: Within 31 days after the administration of any study vaccine dose
measure: Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study
timeFrame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
measure: Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period
timeFrame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
measure: Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
timeFrame: Before (pre) and one month after (post) the administration of Dose 2
measure: Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
timeFrame: Before (pre) and one month after (post) the administration of Dose 2
measure: Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
timeFrame: Before (pre) and one month after (post) the administration of Dose 2
measure: Anti-hepatitis A Virus Antibodies Concentration
timeFrame: Before (pre) and one month after (post) the administration of Dose 2
measure: Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value
timeFrame: Before (pre) and one month after (post) the administration of Dose 2
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.