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

• ClinicalTrials.gov Identifier: NCT00513409
• Recruitment Status: Completed
• First Posted: August 8, 2007
• Results First Posted: August 11, 2009
• Last Update Posted: December 18, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Tracking Information

• First Submitted Date: August 7, 2007
• First Posted Date: August 8, 2007
• Results First Submitted Date: March 11, 2009
• Results First Posted Date: August 11, 2009
• Last Update Posted Date: December 18, 2018
• Study Start Date: August 22, 2007
• Actual Primary Completion Date: February 20, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 4, 2010)

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited) [ Time Frame: Within 4 days after the administration of any study vaccine dose ]

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).

• Original Primary Outcome Measures (submitted: August 7, 2007): Occurrence of grade 3 adverse events after administration of any study vaccine dose
• Change History: Complete list of historical versions of study NCT00513409 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: November 4, 2010)

• Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within 4 days after the administration of any study vaccine dose ]
  Solicited local symptoms assessed include pain, redness and swelling.
• Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within 4 days after the administration of any study vaccine dose ]
  Solicited general symptoms assessed include drowsiness, fever, irritability and loss of appetite. Fever was defined as rectal temperature ≥ 38 degrees Celsius.
• Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within 31 days after the administration of any study vaccine dose ]
  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.
• Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study [ Time Frame: Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose) ]
  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.
• Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period [ Time Frame: Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up) ]
  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.
• Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
  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.
• Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
  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.
• Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
  Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
• Anti-hepatitis A Virus Antibodies Concentration [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
  Concentration of anti-hepatitis A antibodies given as geometric mean concentration (GMC) in milli-international units per milliliter (mIU/mL).
• Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value [ Time Frame: Before (pre) and one month after (post) the administration of Dose 2 ]
  Anti-hepatitis A antibodies cut-off value assessed was ≥ 15 mIU/mL.

• Original Secondary Outcome Measures (submitted: August 7, 2007): Occurrence of solicited local and general symptoms, Occurrence of unsolicited adverse events, Occurrence of serious adverse events during active phase of study, Assess vaccine immunogenicity
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Double (Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Infections, Streptococcal

Intervention

• Biological: Synflorix
  Intramuscular injection, 1 or 2 doses
• Biological: Infanrix Hexa
  1 Intramuscular injection
  Other Name: DTPa-HBV-IPV/Hib
• Biological: Havrix
  1 Intramuscular injection

Study Arms

• Experimental: 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).
  Interventions:

  • Biological: Synflorix
  • Biological: Infanrix Hexa
  • Biological: Havrix
• Experimental: 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).
  Interventions:

  • Biological: Synflorix
  • Biological: Infanrix Hexa

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2008): 163
• Original Estimated Enrollment (submitted: August 7, 2007): 240
• Actual Study Completion Date: August 28, 2008
• Actual Primary Completion Date: February 20, 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Months to 21 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Chile

Administrative Information

• NCT Number: NCT00513409
• Other Study ID Numbers: 110031
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

• Responsible Party: GlaxoSmithKline
• Study Sponsor: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: May 2018