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

Infections, Streptococcal Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513409
• Other study ID #: 110031
• Status: Completed
• Phase: Phase 2
• Start date: August 22, 2007
• Est. completion date: August 28, 2008

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 28, 2008
• Est. primary completion date: February 20, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 21 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Streptococcal
• Streptococcal Infections

Intervention

Biological:
• Synflorix
Intramuscular injection, 1 or 2 doses
• Infanrix Hexa
1 Intramuscular injection
• Havrix
1 Intramuscular injection

Locations

Country	Name	City	State
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Chile, 

References & Publications (2)

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)	Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).	Within 4 days after the administration of any study vaccine dose
Secondary	Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling.	Within 4 days after the administration of any study vaccine dose
Secondary	Number of Subjects Reporting Solicited General Symptoms	Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite.; Fever was defined as rectal temperature = 38 degrees Celsius.	Within 4 days after the administration of any study vaccine dose
Secondary	Number of Subjects Reporting Unsolicited Adverse Events	An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Within 31 days after the administration of any study vaccine dose
Secondary	Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study	A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose)
Secondary	Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.	Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up)
Secondary	Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value	Anti-pneumococcal antibody cut-off value assessed was 0.20 microgram per milliliter (µg/mL).; The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.	Before (pre) and one month after (post) the administration of Dose 2
Secondary	Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value	Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was = 8; The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F.	Before (pre) and one month after (post) the administration of Dose 2
Secondary	Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value	Anti-protein D antibody cut-off value assessed was = 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).	Before (pre) and one month after (post) the administration of Dose 2
Secondary	Anti-hepatitis A Virus Antibodies Concentration	Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).	Before (pre) and one month after (post) the administration of Dose 2
Secondary	Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value	Anti-hepatitis A antibodies cut-off value assessed was = 15 mIU/mL.	Before (pre) and one month after (post) the administration of Dose 2

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